Compounding Pharmacy Report Reveals Limited Regulation

Posted by Salvatore J. Zambri, founding member and partner

 

The push to regulate compounding pharmacies is beginning to gain more attention on the national front. According to a congressional report released on April 15, 2013, the state-by-state examination last fall into the safety issues surrounding the common practices among compounding pharmacies demonstrates that states do not adequately track, regulate or inspect these pharmacies, exposing patients to unsafe drugs, disease and death.

 

The Markey Report, "State of Disarray," findings and conclusions:

  • "State boards of pharmacy generally do not know which pharmacies engage in compounding, do not know whether pharmacies ship compounded drugs across state
    lines, and do not know which pharmacies manufacture large quantities of compounded
    drugs.
  • Only thirteen state boards of pharmacy know which pharmacies are providing sterile compounding services and only five of these states have inspectors that are trained to identify problems with sterile compounding.
  • States typically do not maintain pharmacy inspection records that enable them to identify systemic and repeated compounding pharmacy safety problems that originate either in-state or out-of-state.
  • States are unable to effectively police compounding pharmacy activities in other states. Moreover, when issues arise with out-of-state pharmacies, states do not consistently inform the origination state or the FDA.
  • Despite general increases in state board of pharmacy budgets, the number of pharmacy inspectors has remained consistently low. Furthermore, states usually do not distinguish between inspections of traditional and compounding pharmacies."

Congressman Markey is among those who support legislation to give the Food and Drug Administration more authority over compounding pharmacies.  A scheduled hearing of a House Energy and Commerce subcommittee will be held on Tuesday, April 16, 2013 to focus on this issue.

I will continue to update our readers on this critical consumer issue as more attention is given to the safety problems of compounding pharmacies. 

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Clinical Specialties Compounding Pharmacy Recalls All Sterile Products

Posted by Salvatore J. Zambri, founding member and partner

 

The FDA has announced that Clinical Specialties Compounding Pharmacy is recalling all sterile products due to lack of sterility assurance.  We have reproduced the FDA notice in its entirity for our readers.

 "Clinical Specialties Compounding Pharmacy Products: Recall - All Sterile Products Recalled Due To Lack of Sterility Assurance

 [Posted 03/21/2013]

AUDIENCE: Health Professional, Pharmacy, Patient

ISSUE: Clinical Specialties is voluntarily recalling all lots of all sterile products repackaged and distributed by the pharmacy due to lack of sterility assurance. The recall of all sterile products is conducted in follow-up to concerns regarding practices at the site which cannot assure the sterility of the products.

BACKGROUND: This expanded recall follows the firm’s initial recall of Avastin on March 18, 2013, due to reports of five patients who have been diagnosed with serious eye infections associated with the use of the product. The Center for Disease Control and Prevention (CDC) notified the FDA of these endophthalmitis infections, which occur inside the eyeball. Endophthalmitis after intravitreal injection is a serious complication that can lead to permanent loss of vision. Clinical Specialties Compounding sterile products covered under this recall were distributed nationwide between October 19, 2012 and March 19, 2013.

RECOMMENDATION: Until further notice, health care providers should stop using all sterile products distributed by Clinical Specialties Compounding and return them to the company. Consumers or Health Care providers with questions regarding this recall may contact Clinical Specialties by phone at 866.880.1915 Monday through Friday between the hours of 10 am to 5 pm EST, or e-mail at clinicalrx@bellsouth.net. Patients who have received any product distributed by Clinical Specialties Compounding and have concerns should contact their healthcare provider.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[03/21/2013 - News Release - FDA]

[03/20/2013 - Press Release - Clinical Specialties ]

Related MedWatch Alert

[03/18/2013 - Press Release - Clinical Specialties ]"

As I have been following the compounding pharmacy investigations, I will continue to share with our readers what I learn regarding this very important consumer safety issue.

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Another Compounding Pharmacy Recalls All Products

 Posted by Salvatore J. Zambri, founding member and partner

 

 A recent U.S. Food and Drug Administration (FDA) press release announced the voluntary recall of all compounded products by Medprep Consulting, Inc. due to potential mold contamination.  We are including the complete FDA press release along with a listing of all the products in the recall.

 "Recall -- Firm Press Release

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

Medprep Consulting Inc. Announces Voluntary Nationwide Recall Of All Lots Of All Compounded Products Due To Potential Mold Contamination

Contact
Consumer:
732-493-3390

Media:
Angelo J. Cifaldi, Esq., R.Ph.
Satish V. Poondi, Esq., R.Ph.
Counsel for Med Prep Consulting Inc.
(732)855-6096

FOR IMMEDIATE RELEASE – March 17, 2013 – Tinton Falls, NJ., Med Prep Consulting, Inc. is voluntarily recalling all lots of all products compounded at its facility. The level of recall is to the user, that is, regional hospital pharmacies and related departments, and physician’s office practices. The recall resulted from the pharmacy being notified by a Connecticut hospital, that it observed visible particulate contaminants in 50 ml bags of MAGNESIUM SULFATE 2GM IN DEXTROSE 5% IN WATER, 50ML FOR INJECTION intravenous solution confirmed to be mold. These were unique and distinct lots compounded and dispensed by the pharmacy to the Connecticut hospital. At this time a total of five (5) contaminated bags were discovered. In an abundance of caution, the pharmacy included all compounded products in the voluntary recall due to lack of sterility assurance.

Administration of an intravenous product found to be contaminated with mold, could result in a fatal infection in a broad array of patients. To date, no injuries or illnesses have been reported.

The products are used for a wide range of therapeutic uses for hospitalized inpatients and outpatients, and, patients directly treated by a health care professional at a physician’s office practice facility or clinic. None of these products are dispensed directly to patients from retail pharmacies or to home care patients for either self-administration or nursing administration. All products are packaged in plastic infusion bags, plastic infusion devices, plastic syringes and glass vials. Products packaged in plastic infusion bags, plastic infusion devices, plastic syringes and glass vials were distributed directly to regional hospital pharmacies located in New Jersey, Pennsylvania, Connecticut, and Delaware. Products packaged in plastic syringes only, were distributed nationwide to physician’s office practice facilities and clinics. All of these products were distributed to the described users through March 13, 2013, from Tinton Falls, New Jersey to both regional and nationwide locations.

Included in the recall are the following product list:

  • Acetylcystiene vials
  • Adenosine Bags
  • Alteplase syringe
  • Atropine syringe
  • Avastin syringe
  • Aztreonam syringe
  • Bacitracin vials
  • Bupivacaine Bag
  • Bupivacaine
  • Epinephrine Bag
  • Bupivacaine Syringe
  • Bupivacaine OnQ Pump
  • Calcium Gluconate Bag
  • Calcium Gluconate syringe
  • Cefazolin syringe
  • Cefazolin Bag
  • Cefepime syringe
  • Cefepime Bag
  • Cefotaxime syringe
  • Cefotetan syringe
  • Cefoxitin syringe
  • Ceftazidime syringe
  • Ceftazidime Bag
  • Ceftriaxone syringe
  • Ceftriaxone Bag
  • Cefuroxime syringe
  • Cefuroxime Bag
  • Clindamycin syringe
  • Darboepoetin (Aranesp) syringe
  • Denusumab Syringe
  • Dexamethasone Bag
  • Diltiazem Bag
  • Diphenhydramine Bags
  • Dobutamine Bag
  • Dobutamine syringe
  • Ephedrine syringes
  • Epinephrine Bag
  • Epinephrine Bag
  • Epinephrine syringe
  • Epoetin Alfa syringe
  • Esmolol syringes
  • Famotidine syringe
  • Fentanyl Citrate Bag
  • Fentanyl Citrate with Bupivacaine HCL Bag
  • Gentamicin syringe
  • Gentamicin Bag
  • Glycopyrrolate syringes
  • Granisetron syringe
  • Hectoral syringe
  • Heparin syringe
  • Heparin bag
  • Hydromorphone syringe
  • Hydromorphone Bag
  • Hydromorphone PCA syringe
  • LET Gel syringe
  • LET Soln syringe
  • Leukine syringe
  • Magnesium Sulfate bag
  • Meperidine Bag
  • Methadone Syringe
  • Midazolam Bag
  • Midazolam syringe
  • Morphine Sulfate Bag
  • Morphine Sulfate syringe
  • Norepinephrine bag
  • Norepinephrine Syringe
  • Ondansetron Bag
  • Ondansetron – Dexamethasone Bag
  • Ondansetron syringe
  • Oxacillin syringe
  • Oxacillin Bag
  • Oxytocin bag
  • Palanosetron (Aloxi) syringe
  • Penicillin syringe
  • Penicillin Bag
  • Phenylephrine Bags
  • Phenylephrine syringes
  • Potassium Chloride Bag
  • Potassium Phosphate l bag
  • Ranitidine syringe
  • Rituxan syringe
  • Ropivacaine Bag
  • Ropivacaine OnQ Pump
  • Sodium Citrate syringe
  • Sodium Phosphate bag
  • Succinylcholine syringes
  • Sufentanil with Bupivacaine Bag
  • Timentin syringe
  • Tobramycin syringe
  • Vancomycin Bags
  • Zometa syringe

All facilities that received any product compounded by Med Prep Consulting, Inc. have been notified by telephone fax, electronic mail and regular mail of the recall and have been instructed to remove and return the product to the pharmacy. Facilities with questions may contact the company at 732-493-3390, Monday through Friday, between 10:00 a.m. and 5:00 p.m. EST.

Product complaints related to this recall should be reported to 732-493-3390, Monday through Friday, between 10:00 a.m. and 5:00 p.m. EST.

Adverse events that may be related to the use of these products may be reported to FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by fax:

As I have been following the compounding pharmacy investigations, I will continue to share with our readers what I learn regarding this very important consumer safety issue.

Do you have any questions about this post?

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FDA Recall: DePuy Orthopaedics Class I Recall for LPS Diaphyseal Sleeve

Posted by Salvatore J. Zambri, founding member and partner

 

The FDA recently announced a Class 1 Recall for DePuy Orthopedics.  We are reproducing the recall notice below for our readers in its entirety.  If you anticipate or have recently had knee replacement surgery, please consult with your surgeon regarding the type of implant and possible symptoms or issues related to it.

"DePuy Orthopaedics LPS Diaphyseal Sleeve: Class I Recall - Taper Connection May  Not Accommodate Physiologic Loads

[Posted 02/22/2013]

AUDIENCE: Orthopedics, Surgery, Risk Manager

ISSUE: FDA notified healthcare professionals of a Class I recall of the LPS Diaphyseal Sleeve. The LPS Diaphyseal Sleeve to Diaphyseal Sleeve Base taper connection may not be sufficient to accommodate potential physiologic loads that may be transferred to the junction during normal gait activities by some patients. This may result in fracture of the sleeve at the taper joint which may also lead to loss of function or loss of limb, infection, compromised soft tissue or death.

The FDA has received a total of 10 reports (6 fractures and 4 reports of loosening that may or may not be attributed to the same device design issue) of incidents in which the device has malfunctioned.

The affected devices were manufactured from 2008 to July 20, 2012. See the Recall notice for a list of affected product codes and lot numbers.

BACKGROUND: The LPS Diaphyseal Sleeve is intended for use with the LPS System which is an end-stage revision knee product that allows surgeons to reconstruct severe soft tissue and bony defects. The diaphyseal sleeve is intended to enhance the fit and fill of the diaphyseal femoral canal with femoral and tibial replacements.

RECOMMENDATION: On Jan. 4, 2013, DePuy issued an Urgent Medical Device Recall informing hospitals and surgeons of the problem and to immediately stop distributing or using the recalled lots. If a medical facility has the affected product in stock, it should be returned to DePuy.

DePuy is not recommending revision or additional follow up in the absence of symptoms of patients with this implanted device. However, DePuy is encouraging surgeons to communicate with patients who received these implants and discuss the risks of the implant fracture and the method for detecting implant failure if the patient begins experiencing symptoms.


Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178


[02/22/2013 - Recall Notice - FDA]"

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Anticlotting Drug Pradaxa Allegedly Causing Deaths

Posted by: Salvatore J. Zambri, founding member and partner

 

Please read the front-page of the Business Day section of the New York Times (11/3, B1, Thomas, Subscription Publication, 1.23M), which reported that blockbuster anticlotting drug Pradaxa is producing deaths from unstoppable bleeding, and critics are taking aim at the FDA "because it allowed a potentially dangerous drug to be sold without an option for reversing its effects." Unlike warfarin, Pradaxa - or dabigatran - has no antidote to stop its blood-thinning ability. The Times adds, "Pradaxa is an example, some critics say, of what can happen when a drug that performs well in tightly controlled trials is released into the messy world of real-life medicine. Boehringer Ingelheim said it was working on developing an antidote but that even without one, patients in a large clinical trial died at roughly the same rate as those who were taking warfarin."

Please consult with your doctor before taking any medication.

Do you have questions about this post?

About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. The association has recently named him the " 2011 Trial Lawyer of the Year".  He has also been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri was recently (2012 edition) acknowledged as one of the "Best Lawyers in America" by Best Lawyers, and has also been repeatedly named a "Super Lawyer" by Law and Politics magazine (2012)--a national publication that honors the top lawyers in the country.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning defective drugs, medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com.  You may also reach him at 202-822-1899.

Posted In Medications , Men's Health Issues , Patient Safety , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Merck to Settle Rofecoxib Class-Action Suit

Posted by: Salvatore J. Zambri, founding member and partner


The AP (11/2) reported Merck & Co. Inc. announced Nov. 1 that it has "agreed to settle a class action lawsuit filed on behalf of Missouri consumers" over its prescription painkiller Vioxx (rofecoxib). The FDA "approved Vioxx as a painkiller in May 1999," but the Justice Department "said Merck began marketing it almost immediately" off-label as a rheumatoid arthritis treatment, an indication for which the FDA did not grant approval "until 2002." The proposed agreement would settle "claims that New Jersey-based Merck violated the Missouri Merchandising Practices Act by promoting and selling Vioxx, which Merck pulled from the shelves eight years ago because of evidence that it doubled users' chances of suffering a heart attack or stroke."

According to the Philadelphia Inquirer (11/4, Sell, 346K), the agreement "calls for Merck to pay $39 million to $220 million, depending on how many members of the class are certified." Notably, the proposed settlement offers consumers the choice of two options: Based on a "one-month drug cost of $90," they could obtain a "onetime payment of $180 if they submit a claim with a declaration under oath, but provide no proof." Or, by "declaring under oath and providing proof of payment," consumers could claim "$90 for each month" they purchased Vioxx.

The St. Louis Business Journal (11/2, Weiderman, Subscription Publication) noted that the "case, which has been pending since 2004, was moved to federal court before the 8th US Circuit Court of Appeals moved it to plaintiff-friendly Jackson County." The proposed settlement "must be approved by the Jackson County Circuit Court before it becomes final."
 

Do you have questions about this post?

About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. The association has recently named him the " 2011 Trial Lawyer of the Year".  He has also been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri was recently (2012 edition) acknowledged as one of the "Best Lawyers in America" by Best Lawyers, and has also been repeatedly named a "Super Lawyer" by Law and Politics magazine (2012)--a national publication that honors the top lawyers in the country.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning defective drugs, medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com.  You may also reach him at 202-822-1899.

Posted In Medications , Men's Health Issues , Patient Safety , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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A Family Impacted by Compounding Pharmacy's Tainted Medications Seeks to Transfer all Related Cases to A Minnesota Court

By Catherine Bertram, partner

                                                                                                             

A family that filed a contaminated steroid case against New England Compounding Pharmacy asked the the Judicial Panel on Multidistrict Litigation to transfer all federal compounding pharmacy cases to the U.S. District of Minnesota for consolidated pretrial proceedings.

It is reported that attorneys for Brenda and Robert Bansale made this request in a filing earlier this week.  They argue all the compounding pharmacy cases should be combined for motion practice, discovery and damage issues because it  will involve the same evidence and arguments and therefore consolidation is appropriate under the federal code.

We are investigating several cases of tainted medication for families and our firm participates in these class actions, commonly referred to as MDLs (multi-district litigation)  across the country for clients from various states.  If you have questions about this litigation feel free to call me.  202-822-1875.

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Doctor Contends 15 Dead in NECC Medication Contamination was Preventible and Predictable

By Catherine Bertram

                                                                                                            

According to Dr. Michael Carome, of Public Citizen, the fungal meningitis outbreak associated with 15 recent deaths and over 200 serious illnesses was completely preventable.  In an article released by CNN, Dr. Carome contends that,  "(T)he injectable steroid medication produced at the center was never approved by the FDA and was not manufactured in accordance with the FDA's rigorous manufacturing standards designed to ensure that drugs are sterile and uncontaminated with such germs as bacteria or fungi before being sold and distributed.

As a result, as many as 14,000 patients in 23 states were exposed to potentially contaminated steroids and need to be monitored for signs of fungal meningitis or other infections."

Dr. Carome contends that many entities are responsible for this preventable deadly outbreak, "(W)hile numerous probes and investigations are just getting under way and litigation targeting the producer of the tainted drug and health care providers who used it will certainly take years to resolve, blame for this disaster will undoubtedly rest with many parties. Among them are the compounding pharmacy that produced the contaminated steroid drugs, health care facilities and providers who chose to use a dangerous drug lacking approval by the FDA and evidence that the products were sterile, trade associations and professional groups representing compounding pharmacies that have vigorously resisted federal regulatory oversight of their members, state and federal regulators, and Congress."

On October 4, the Federal Drug Administration (FDA) advised health care providers not to use any New England Compounding Center (NECC) products after a patient was diagnosed with meningitis that was possibly associated with an epidural injection of a steroid medication.   On October 6, NECC announced a recall of all of its products.  Click here for a complete list of the  products subject to this recall.  

The FDA is advising healthcare professionals to follow up with patients who were administered any injectible medication from or produced by NECC after May 12, 2012.  

We are currently investigating cases involving tainted medication such as this. If you or a family member has questions about this please call me for a free consultation.  202-822-1875.

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So You Think Your Medical Device Was Safety Tested? Think Again.

Posted by: Salvatore J. Zambri, founding member and partner

Medical devices such as artificial joints, heart defibrillators and surgical mesh have become an integral part of the healthcare industry.  As consumers, we would naturally expect that those devices have been tested for safety and effectiveness. In reality, many implants and other high-risk devices on the market have not undergone any safety testing.  Rather, the manufacturers have frequently only  filed paperwork and paid the mandatory FDA user fee to market those items. 

In 2011, the Institute of Medicine of the National Academies, an independent, non-profit organization that works outside of the government to provide unbiased and authoritative advice to decision-makers and the public, released a consensus report concluding that "the FDA’s finite resources would be better invested in developing an integrated premarket and postmarket regulatory framework that provides a reasonable assurance of safety and effectiveness throughout the device life cycle." In summary, they recommended that the FDA completely overhaul its system that regulates medical devices because presently it doesn't ensure patient safety either before or after products are on the market.  Surprisingly, Congress is currently working on a new law that neither addresses the failures of the current FDA process nor forces manufacturers to sufficiently safety test devices. Rather, its goal is to allow them to market devices even faster.  That's a shame.

Continue Reading Posted In Medical Malpractice , Men's Health Issues , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Sedona Labs Recalls iFlora Children's Supplements

Posted by: Salvatore J. Zambri, founding member and senior partner


Reuters (7/11, Simpson) reports that Atrium Innovations Inc.'s Sedona Labs unit is recalling its iFlora 4-Kids Powder, sold by healthcare professionals, and its iFlora Kids Multi-Probiotic, sold online and in US health food stores, due to possible contamination of a galactooligosaccharide component with salmonella. To date, no salmonella-related incidents have been reported. According to a company statement, the products involved have a distribution date range from March 16 through May 3. The recall affects the following lot numbers: 1074711, 1479611, 1640811 and 1734411.

Please do not consume this potentially contaminated product or provide it to your children.  I advise you to speak to a physician about what alternatives can be provided.

Be safe.

Do you have questions about this post?

About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. The association has recently named him the " 2011 Trial Lawyer of the Year".  He has also been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri was recently (2012 edition) acknowledged as one of the "Best Lawyers in America" by Best Lawyers, and has also been repeatedly named a "Super Lawyer" by Law and Politics magazine (2012)--a national publication that honors the top lawyers in the country.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning defective drugs, medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com.  You may also reach him at 202-822-1899.

Posted In Medications , Pediatrics , Product Liability , Public Health , U.S. Food and Drug Administration Warnings
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Stryker Recalls Modular Neck-Stem Devices Attaching to Artificial Hips

Posted by: Salvatore J. Zambri, founding member and senior partner


The Boston Business Journal (7/10, Donnelly, Subscription Publication) reported, "Stryker Orthopaedics has voluntarily recalled two brands of devices used in conjunction with artificial hips in hip replacement surgeries, according to the US Food and Drug Administration website." To date, "there have been at least 45 adverse event reports from patients who say the devices caused pain and/or tissue swelling." This week, Stryker said that "it would remove Rejuvenate and ABG II modular-neck stems, which attach to artificial hips, from the market and cease global distribution."

The modular neck-stem devices were recalled "because of postmarketing data showing fretting and corrosion at the modular neck junction, according to an alert from the US Food and Drug Administration (FDA)," Medscape (7/11, Hitt) reports. "The FDA posted the company's press release, dated July 6." Stryker "states that patients who already have the implanted modular-neck stems should contact their surgeon only if they experience pain and/or swelling of the hip and should undergo revision surgery only if symptoms of pain and swelling at the local joint site are not attributable to other conditions such as aseptic loosening and periprosthetic sepsis."

If you have had a hip replacement, or if you are thinking of getting one, please speak with your doctor about product safety.  I have many clients who have been victims of faulty hip replacements, and they are left with a lifetime of pain and suffering.

Do you have questions about this post?

About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. The association has recently named him the " 2011 Trial Lawyer of the Year".  He has also been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri was recently (2012 edition) acknowledged as one of the "Best Lawyers in America" by Best Lawyers, and has also been repeatedly named a "Super Lawyer" by Law and Politics magazine (2012)--a national publication that honors the top lawyers in the country.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning defective drugs, medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com.  You may also reach him at 202-822-1899.

Posted In Men's Health Issues , Patient Safety , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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FDA Links Cholesterol-Reducing Medications to Other Medical Issues

Posted by: Salvatore J. Zambri, founding member and partner

The Food and Drug Administration (FDA) has now officially linked cholesterol-reducing drugs to cognitive problems, diabetes and muscle pain.  Some important safety labeling changes are now to be included on these drugs, generally known as statins, including Lipitor, Lescol, Mevacor, Altoprev, Livalo, Pravachol, Crestor, and Zocor, as well as several combination products.

According to the director for the Division of Metabolism and Endocrinology Products in the Office of Drug Evaluation II in FDA's Center for Drug Evaluation and Research, “We want health care professionals and patients to have the most current information on the risks of statins, but also to assure them that these medications continue to provide an important health benefit of lowering cholesterol." 

Currently, more than 20 million Americans take some form of statin medication.  While the benefits of these drugs are certainly not disputed, the FDA's ongoing review of medical literature, clinical trial data and reports of adverse events prompted the new cautions. 

Listed below are the specific labeling changes that will be required:

  • "The drug labels have been revised to remove the need for routine periodic monitoring of liver enzymes in patients taking statins. FDA now recommends that liver enzyme tests should be performed before starting statin therapy, and as clinically indicated thereafter. FDA has concluded that serious liver injury with statins is rare and unpredictable in individual patients, and that routine periodic monitoring of liver enzymes does not appear to be effective in detecting or preventing this rare side effect. Patients should notify their health care professional immediately if they have the following symptoms of liver problems: unusual fatigue or weakness; loss of appetite; upper belly pain; dark-colored urine; yellowing of the skin or the whites of the eyes.
  • Certain cognitive (brain-related) effects have been reported with statin use. Statin labels will now include information about some patients experiencing memory loss and confusion. These reports generally have not been serious and the patients’ symptoms were reversed by stopping the statin. However, patients should still alert their health care professional if these symptoms occur.
  • Increases in blood sugar levels (hyperglycemia) have been reported with statin use. The FDA is also aware of studies showing that patients being treated with statins may have a small increased risk of increased blood sugar levels and of being diagnosed with type 2 diabetes mellitus. The labels will now warn healthcare professionals and patients of this potential risk.
  • Health care professionals should take note of the new recommendations in the lovastatin label. Some medicines may interact with lovastatin, increasing the risk for muscle injury (myopathy/rhabdomyolysis). For example, certain medicines should never be taken (are contraindicated) with Mevacor (lovastatin) including drugs used to treat HIV (protease inhibitors) and drugs used to treat certain bacterial and fungal infections."

If you or a member of your family are currently taking any of the listed statin medications for the reduction of cholesterol, please consult with your personal physician to determine the potential risks of these drugs. Patients should report any side-effects to their physician. As with any medications, do not attempt to quit taking your prescriptions without consulting a medical professional first.  Doing so often causes unintended medical complications.    

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Some NSAIDS May Increase Risk of Birth Defects

Posted by: Salvatore J. Zambri, founding member and partner


Reuters (12/13, Thrasybule) reported a study in the American Journal of Obstetrics and Gynecology suggesting that some over-the-counter painkillers, when taken during early pregnancy, may slightly increase the risk of rare birth defects. For instance, aspirin and naproxen have been linked to babies with either anophthalmia or microphthalmia. Other conditions that saw a rise in risk with painkiller use included amniotic band syndrome, cleft palate, and spina bifida. However, the researchers noted that the majority of NSAIDs were not tied to birth defects, and emphasized that the study does not prove that the painkillers caused the increased risk. An expert not involved with the study suggested avoiding ibuprofen, aspirin or naproxen altogether and using acetaminophen for pain relief instead.

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About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. The association has recently named him the " 2011 Trial Lawyer of the Year".  He has also been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri was recently (2011 edition) acknowledged as one of the "Best Lawyers in America" by Best Lawyers, and has also been repeatedly named a "Super Lawyer" by Law and Politics magazine (2011)--a national publication that honors the top lawyers in the country.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning defective drugs, medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com.  You may also reach him at 202-822-1899. 

Posted In Medications , Men's Health Issues , Patient Safety , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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FDA Alert Issued Regarding Avastin

Posted by: Salvatore J. Zambri, founding member and senior trial attorney.

According to a recent alert issued by the U.S. Food and Drug Administration (FDA), health care professionals are being cautioned as a result of recent serious eye infections resulting from Avastin injections.  Several recent incidents of patients losing all remaining vision after Avastin injections prompted the FDA alert.  Although Avastin is approved for treatment of some cancers, it has not been approved, but is frequently-prescribed treatment for wet age-related macular degeneration (AMD). Regulators and manufacturers warn against unapproved use of Avastin, citing infection and loss of vision as examples of the risks associated with doing so. It is believed that the tainted injections were from a pharmacy that repackaged the preservative-free vials into smaller single-use syringes.  The investigation continues.

The FDA alert states: "Health care professionals should be aware that repacking sterile drugs without proper aseptic technique can compromise product sterility, potentially putting the patient at risk for microbial infections.  Healthcare professionals should ensure that drug products are obtained from appropriate, reliable sources and properly administered.  Avastin solution for intravenous infusion is approved for the treatment of various types of cancers.  Some physicians also prescribe Avastin off-label for the treatment of wet age-related macular degeneration, although Avastin is not currently approved for this indication."

Genentech, the division of Roche that manufactures Avastin, maintains that caution against unapproved use was always advised.  According to a Genentech spokesman, "Avastin is not manufactured or approved and to date has not been proven safe for use in the eye."  Many ophthalmologists argue that Avastin is a much cheaper alternative treatment of wet AMD and that the infection and vision-loss incidents are due to carelessness instead.  The safety debate regarding off-label use continues.

Please check with your doctor if you have been prescribed any off-label medications.  Although some off-label prescribing of medication has existed for an extended period of time, the fact that serious infections and even blindness can occur when a cancer medication to treat eye disease reveals that it is a risky practice. 

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Continue Reading Posted In Medications , Patient Safety , U.S. Food and Drug Administration Warnings
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Pfizer Under-Reported Side Effects of Smoking-Cessation Drug, Says Report

Posted by: Salvatore J. Zambri, founding member and senior trial attorney.             


ABC News reports that a new analysis by the Institute for Safe Medication Practices "says that there were 150 instances" where users of the smoking-cessation drug Chantix committed suicide "out of the nearly 600 delayed reports of severe issues noted in the study."  As a result, the FDA "wants the drug maker to resubmit thousands of records to get a clearer idea of just how widespread severe reactions to Chantix are, which also include vivid nightmares, depression and violent outbursts."

I applaud the FDA in demanding Pfizer to release its records.  Decisions to market drugs should be based principally on patient safety and health, not on profits.  It would be a shame if people lost their lives as a result of using a drug after side-effects were concealed.

Do you have any questions about this post?

About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. The association has recently named him the " 2011 Trial Lawyer of the Year".  He has also been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri was recently (2011 edition) acknowledged as one of the "Best Lawyers in America" by Best Lawyers, and has also been repeatedly named a "Super Lawyer" by Law and Politics magazine (2011)--a national publication that honors the top lawyers in the country.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning defective drugs, medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com.  You may also reach him at 202-822-1899.

Posted In Men's Health Issues , Patient Safety , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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FDA Issues New Guidelines for CT Scanning

Posted by: Salvatore J. Zambri, founding member and senior trial attorney     

As reported in a recent article by the New York Times, "the Food and Drug Administration has concluded that manufacturers of CT scanners should do a better job of training and educating those who use their equipment, and that the machines themselves could be made safer by warning operators that a dangerously high radiation dose is about to be administered.

These two conclusions . . . are the result of a yearlong investigation by the F.D.A. into hundreds of radiation overdoses in 2008 and 2009 that occurred during a specific diagnostic test for a stroke, called a CT brain perfusion scan."

Over-radiation can be very dangerous.  Manufacturers of scanners and physicians must work together to maximize patient safety.

Do you have any questions about this post?

About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri was recently (2011 edition) acknowledged as one of the "Best Lawyers in America" by Best Lawyers, and has also been repeatedly named a "Super Lawyer" by Law and Politics magazine (2010)--a national publication that honors the top lawyers in the country.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.

 

 

 

Posted In Men's Health Issues , Patient Safety , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Litigation Over DePuy Hip Replacements Rising

Posted by: Salvatore J. Zambri, founding member and senior attorney     

An August recall of DePuy ASR hip implants had led to lawsuits.  The suits claim that the manufacturer knew its product was failing, but nevertheless continued to sell it for profit without informing consumers.

The problem seems to be with the metal-on-metal design of the device, which does not appear to adhere well in the hip joint.  Consequently, the failed replacements have to be re-done, often at a terrible cost both financially and physically. Some patients have suffered metal poisoning, and others are having a hard time ambulating.

My firm regularly represents victims of product defects.  It is a shame when you see companies put profits over people.  Bad things--tragic things--happen when that business model is used.

Do you have any questions about this post?

About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri was recently (2011 edition) acknowledged as one of the "Best Lawyers in America" by Best Lawyers and has also been repeatedly named a "Super Lawyer" by Law and Politics magazine (2010)--national publications that honor the top lawyers in the country.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.

Posted In Men's Health Issues , Patient Safety , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Nurses Union States Understaffing At DC Hospital Jeopardizes Patient Care

Posted by: Salvatore J. Zambri, founding member and senior attorney     

The nation's largest nurses union has asked the D.C. Health Department on Monday to investigate nurse under-staffing at Washington Hospital Center.  According to the union, under-staffing is jeopardizing patient care.

The National Nurses United union filed a 19-page report with the D.C. Health Department, which documents 50 separate instances of what it describes as unsafe patient care across all departments in the hospital this year.

As the Washington Post reported, the union filing describes "instances of patients not receiving medication on time, newborn infants not being fed promptly and a patient who was rushed back to the operating room after the patient had stopped breathing and suffered cardiac arrest. The union did not know whether the patient survived."  The full Post article can be read by clicking here.

Under-staffing is a major issue that plagued hospitals across the country.  It is important for hospitals to put safety above profits and staff their facilities appropriately.  If they don't, patients will be seriously injured and killed.  I represent victims of medical malpractice and their families every day.  All too often the harms caused to patients could have been easily avoided if sufficient competent staff was in place to monitor and treat patients. 

I hope the union report spurs positive change.

Do you have any questions about this post?

About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri was recently (2011 edition) acknowledged as one of the "Best Lawyers in America" by Best Lawyers and has also been repeatedly named a "Super Lawyer" by Law and Politics magazine (2010)--national publications that honor the top lawyers in the country.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.

Posted In Medical Malpractice , Medications , Men's Health Issues , Patient Safety , Pediatrics , Public Health , U.S. Food and Drug Administration Warnings
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Candy and Candy-like Tablet Recalled

Posted by: Salvatore J. Zambri, founding member and senior attorney     

With Halloween approaching, it is appropriate to consider which candies children should and should not eat.  CQ HealthBeat (10/26) reports, "The Food and Drug Administration on Monday put out a warning that Hyland's Teething Tablets may pose a risk to children and the company has agreed to a voluntary recall. The agency also passed along recall information about two candy products in this week before Halloween." Notably, the "teething relief product, manufactured by the Standard Homeopathic Company, contains a small amount of belladonna, a substance that can cause serious harm at larger doses."

In addition, "Nestlé USA's Confections & Snacks Division has voluntarily recalled its Raisinets Fun Size Bags, which the company says may contain peanuts even though there is nothing on the label to indicate that" peanuts are included in the snacks.  Also, "Colombina, S.A., which manufacturers Mega Pops brand lollipops, is recalling specific lots of the candy" since "certain packages may contain 'traces of foreign particles.'"

Enjoy Halloween, but please put safety first.

Do you have any questions about this post?

About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri was recently (2011 edition) acknowledged as one of the "Best Lawyers in America" by Best Lawyers and has also been repeatedly named a "Super Lawyer" by Law and Politics magazine (2010)--national publications that honor the top lawyers in the country.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.

Posted In Medications , Men's Health Issues , Patient Safety , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Sulindac Caused Blindness, Scarring

Posted by: Salvatore J. Zambri, founding member and senior attorney     

The AP (9/9, Tuohy) reports, "A federal jury in New Hampshire has awarded $21 million to a woman blinded and scarred by a prescription drug she took for shoulder pain. Karen Bartlett, 51, of Plaistow suffered extreme burns to her skin, mucus membranes and eyes after taking the anti-inflammatory drug Sulindac." After taking the medication for two weeks, Bartlett "was admitted to the hospital" and "was diagnosed as having Stevens-Johnson Syndrome and toxic epidermal necrolysis (SJS/TEN)." The jury concluded "that Philadelphia-based Mutual Pharmaceutical Co. was liable for her injuries and should have known the drug was unreasonably dangerous to consumers."

If you have been taking the drug, please stop ingesting it and speak to your doctor. 

Do you have any questions about this post?

About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri was recently (2011 edition) acknowledged as one of the "Best Lawyers in America" by Best Lawyers and has also been repeatedly named a "Super Lawyer" by Law and Politics magazine (2010)--national publications that honor the top lawyers in the country.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899. 

Posted In Medications , Men's Health Issues , Patient Safety , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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AstraZeneca Pays $198Mill To Settle 17,500 Lawsuits

Posted by: Salvatore J. Zambri, founding member and senior attorney     

Bloomberg News (8/9, Feeley, Kelley) reports, "AstraZeneca Plc will pay about $198 million to settle 17,500 lawsuits, or about two-thirds of the total, alleging its antipsychotic drug Seroquel causes diabetes in some users." As I mentioned in an earlier blog, AstraZeneca "previously agreed to pay at least $55 million to resolve more than 5,500 cases alleging the company knew Seroquel could cause diabetes and failed to adequately warn patients, people familiar with those settlements said. These earlier agreements are part of the 17,500 settlements, the company said." The Financial Times (8/9, Jacobs) reports that the settlement stems from court-ordered mediation, a process where the parties meet together, discuss the issues, and work to come to a fair resolution. The Wall Street Journal (8/9, Zekaria) reported that analysts called the settlement figure relatively small, given the alleged defect of the product at issue. The AP (8/9) also covered the story.

Do you have any questions about this post?

About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri was recently (2011 edition) acknowledged as one of the "Best Lawyers in America" by Best Lawyers, and has also been repeatedly named a "Super Lawyer" by Law and Politics magazine (2010)--a national publication that honors the top lawyers in the country.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.

Posted In Medications , Men's Health Issues , Patient Safety , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Dietary Supplements Have Unsafe Ingredients, Says Consumer Reports

Posted by: Salvatore J. Zambri, founding member and senior attorney     

ABC World News (8/3, story 8, 1:50, Sawyer) reported, "Dietary supplements are a $27 billion a year business in this country, but Consumer Reports has an alert" on "supplements the magazine says can be dangerous to your health." Consumer Reports' Nancy Metcalf said, "With the dozen supplements that we've identified, we think it's all risk and no benefit."

The Los Angeles Times (8/4, Stein) notes that the list of those that are unsafe include "aconite, bitter orange, chaparral, colloidal silver, coltsfoot, comfrey, country mallow, germanium, greater celandine, kava, lobelia, and yohimbe." The report also "argues that the FDA has not fully used its limited authority granted by the Dietary Supplement Health and Education Act to ban supplement ingredients that may be dangerous."

The Washington Post (8/4) adds that supplement manufacturers "routinely, and legally, sell their products without first having to demonstrate that they are safe and effective."

Before taking any dietary supplement, or any medication for that matter, please consult with your doctor.  Be safe.

Do you have any questions about this post?

About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims.  Mr. Zambri has also been acknowledged as one of "The Best Lawyers in America" by Best Lawyers (2011 edition), and has been repeatedly named a "Super Lawyer" by Super Lawyer magazine (March/April 2010)-- national publications that honor the top lawyers in America.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.


 

Posted In Medications , Men's Health Issues , Patient Safety , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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FDA Wants Tougher Medical Device Regulation

Posted by: Salvatore J. Zambri, founding member     

The AP (8/4, Perrone) reports that "makers of X-ray machines, drug pumps and other medical devices would have to submit more safety information to win federal approval under a proposal designed to tighten regulation of thousands of products reviewed each year." The FDA "released recommendations Monday night designed to improve oversight of the US device industry, including the government's ability to recall products that prove unsafe or ineffective." At "the center of the overhaul" is the so-called 510(k) system the FDA "uses to grant speedy approval to devices that are deemed similar to products already on the market." FDA critics "say that high-risk devices, such as heart pacemakers, are increasingly slipping through the 510(k) process without thorough testing and scrutiny."

The Minneapolis Star Tribune (8/4, Moore) reports among the recommendations released is the creation of "a new class of devices that would require clinical evidence before gaining 510K approval." The designation "would streamline the process for a 'small subset' of devices by telling applicants up-front what will be required to gain marketing clearance, thus avoiding delays." As it stands, "only 8 to 10 percent of the devices approved under the 510(k) moniker require clinical studies," said Jeffrey Shuren, director of the FDA's device center.

Increased oversight is needed, so that patients' health and lives are not put at risk.  Safety must be put above profits.

Do you have any questions about this post?

About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri has also been acknowledged as one of "The Best Lawyers in America" by Best Lawyers (2011 edition), and has been repeatedly named a "Super Lawyer" by Super Lawyer magazine (March/April 2010)-- national publications that honor the top lawyers in America.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.


 

Posted In Men's Health Issues , Patient Safety , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Senate Bill Introduced To Increase FDA Safety Oversight

Posted by: Salvatore J. Zambri, founding partner     

The Hill 's (8/4, Lillis) "Healthwatch" blog reports, "citing a recent spike in pharmaceutical recalls, Sen. Michael Bennet on Tuesday introduced legislation to bolster consumer protections governing the nation's drug supply." The "Colorado Democrat says his proposal," which would "greatly expand the FDA enforcement powers while holding drug companies more accountable for the products they sell," is "vital in a globalized age when more and more drug ingredients originate overseas."

I applaud this introduction of this important legislation.  The lack of oversight has allowed drug and other product manufacturers to push products into the market for profit without proper safety considerations.  Let's hope Congress will do the right thing and make this bill law.

Do you have any questions about this post?

About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims.  Mr. Zambri has also been acknowledged as one of "The Best Lawyers in America" by Best Lawyers (2011 edition), and has been repeatedly named a "Super Lawyer" by Super Lawyer magazine (March/April 2010)-- national publications that honor the top lawyers in America.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.

Posted In Medications , Men's Health Issues , Patient Safety , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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AstraZeneca To Pay $55Mill To Resolve Seroquel Lawsuits

Posted by: Salvatore J. Zambri, founding partner     

As Bloomberg News (8/5, Feeley, Milford) reports, "AstraZeneca Plc, the UK's second-biggest drugmaker, agreed to pay about $55 million to settle around 5,500 lawsuits related to side effects of the antipsychotic Seroquel [quetiapine]." AstraZeneca's "5,500 settlements include 4,000 that AstraZeneca acknowledged in a July 29 regulatory filing." The company "is moving to resolve Seroquel claims as it faces expiring patents on the drug and the ulcer treatment Nexium [esomeprazole] in the next four years."

We hope that these settlements effect how drug companies decide to do business.  They must put patient safety above profits.

Do you have any questions about this post?

About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri has also been repeatedly named a "Super Lawyer" by Law and Politics magazine (2010)--a national publication that honors the top lawyers in America.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.

Posted In Medications , Men's Health Issues , Patient Safety , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Are Drug Studies Reliable or Tainted?

Posted by: Salvatore J. Zambri, founding partner     

A recent analysis of the outcomes of pre-market drug-trials raised some great concerns.  The Los Angeles Times (8/2, Roan) "Booster Shots" blog reported, "According to an analysis of drug trials published Monday, studies were much more likely to be positive -- that is, showing the drug worked -- in trials that were funded by the pharmaceutical industry." A review of 546 drug trials "found that industry-funded trials reported positive outcomes 85% of the time, compared with 50% of the time for government-funded trials and 72% of the time for trials funded by nonprofits or non-federal organizations." But, among "the nonprofit or non-federal studies, those that received industry contributions were more likely to be positive (85%), compared with those that did not have any industry support (61%)."

I'm concerned that drug companies are not sufficiently testing their drugs before pushing them on the market for a profit.  The vast difference in the trial outcomes conducted by teh drug companies and the federal government suggests that the pharmaceutical industry needs to do more to protect consumers.  Safety must be put above profits.

And the non-profit and non-federal organizations involved in performing drug studies need to be careful not to take a blind eye to negative effects of drugs just because drug companies make financial contributions to the entities. 

Do you have any questions about this post?

About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri has also been repeatedly named a "Super Lawyer" by Law and Politics magazine (2010)--a national publication that honors the top lawyers in America.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.  

Posted In Medications , Men's Health Issues , Patient Safety , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Radiation Overdoses More Common, Dangerous Than Previously Believed

 

Posted by: Salvatore J. Zambri, founding partner     

On its front page, the New York Times (7/31, A1, Bogdanich) reports that cases of radiation overdoses during CT brain perfusion scans, which "began to emerge late last summer, set off an investigation by the Food and Drug Administration into why patients tested with this complex yet lightly regulated technology were bombarded with excessive radiation." But, "after 10 months, the agency has yet to provide a final report on what it found." Now, "an examination by the New York Times has found that radiation overdoses were larger and more widespread than previously known, that patients have reported symptoms considerably more serious than losing their hair, and that experts say they may face long-term risks of cancer and brain damage," as well as eye damage. The "review also offers insight into the way many of the overdoses occurred."

Before undergoing a CT scan or any radiological procedure, you should speak to your doctor about the pros and cons of the procedure, and I encourage you to question the facility giving the test to be sure the doses of radiation are not excessive.

Do you have any questions about this post?

About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri has also been repeatedly named a "Super Lawyer" by Law and Politics magazine (2010)--a national publication that honors the top lawyers in America.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.


 

Posted In Cancer Misdiagnosis , Men's Health Issues , Patient Safety , Public Health , U.S. Food and Drug Administration Warnings
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Exposure To Evamist Dangerous For Children And Pets

Posted by: Salvatore J. Zambri, founding partner     

The FDA has warned that "inadvertent exposure to Evamist through skin contact with patients using this product has the potential for adverse effects in children and pets. Evamist contains estradiol, an estrogen hormone, and is used in women to reduce hot flashes during menopause. The drug is sprayed on the skin between the elbow and wrist, on the inside of the forearm. The FDA currently is reviewing reports of adverse events in children and pets who were inadvertently exposed to this topical estrogen product."

According to the announcement, the FDA has received several post-marketing cases of unintended exposure to Evamist in children ages 3 years to 5 years during the period July 2007 through June 2010. "Adverse events reported in unintentionally exposed children include premature puberty, nipple swelling and breast development in females, and breast enlargement in males. Since 2007, two reports of secondary exposure to Evamist in dogs also have been received by FDA’s Center for Veterinary Medicine. Pets exposed to Evamist may exhibit signs such as mammary/nipple enlargement and vulvar swelling."

Please keep your children and pets away from the drug. If you have experienced any adverse side effects from the use of Evamist, please contact the FDA’s MedWatch Adverse Event Reporting program at www.fda.gov/MedWatch or by calling 800-332-1088.

Do you have any questions about this post?

About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri has also been repeatedly named a "Super Lawyer" by Law and Politics magazine (2010)--a national publication that honors the top lawyers in America.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.

Posted In Medications , Men's Health Issues , Patient Safety , Pediatrics , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Glaxo to Pay $1 Billion to Children with Birth Defects from Mothers who took Paxil

                                                                       

By Catherine Bertram

Bloomberg News reported that GlaxoSmithKline P.L.C.  has agreed to pay $1 billion to injured consumers to resolve more than 800 cases involving the antidepressant Paxil.  The medication has been in use in the U.S. since 1992.   Paxil generated about $793 million in sales in 2009 alone which was about 1.8 percent of Glaxo’s total revenue.  Glaxo reported U.S. sales exceeding $11 billion since 1997. 

Not all of the pending birth defect cases are resolved, according to the report, about  100 Paxil claims are not included in this settlement.   Glaxo confirmed that it settled some Paxil cases citing the reason as avoiding costs and uncertainties of litigation, but would not comment on the terms of the settlement.  A Philadelphia jury awarded a 3 year old boy $2.5 million finding that Paxil caused severe heart defects in a trial in October of last year.

About the author:

Catherine Bertram is board certified in civil trials and was recently nominated as a 2010 Super Lawyer for Washington, D.C.  Ms. Bertram has 20 years of trial experience and is unique in that she was formerly the Director of Risk Management for Georgetown University Hospital.  Ms. Bertram is a member of the bar for the U.S. Supreme Court.  She is a partner with the firm and lectures regularly to lawyers and health care providers, nationally and locally, regarding patient safety, medical negligence and other related issues. She has also recently published a chapter in a surgical textbook.   She can be reached by email at cbertram@reganfirm.com or by phone 202-822-1875 in her office in Washington, D.C.

Posted In Medications , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Drinking Miracle Mineral Solution (MMS) Can Cause Serious Harm

Posted by: Salvatore J. Zambri, founding partner     

The U.S. Food and Drug Administration is warning consumers not to take Miracle Mineral Solution, an oral liquid also known as “Miracle Mineral Supplement” or “MMS.”  The product, when used as directed, produces an industrial bleach that can cause serious harm to health.

According to the FDA's website, "The FDA has received several reports of health injuries from consumers using this product, including severe nausea, vomiting, and life-threatening low blood pressure from dehydration.

Consumers who have MMS should stop using it immediately and throw it away."

MMS claims to treat many illnesses and disease, including HIV,  the H1N1 flu virus, common colds, hepatitis, acne, cancer, and other conditions. However, the FDA is not aware of any studies that prove that MMS effectivey treats any of these conditions.

If you have experienced any negative side effects from MMS, please contact your doctor or visit an emergency room as soon as possible.  Do not use the product any longer, and keep it away from others, especially children. Adverse events can be reported to the FDA’s MedWatch program at 800-FDA-1088 or online at www.fda.gov/medwatch/report.htm.

Do you have any questions about this post?

About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri has also been repeatedly named a "Super Lawyer" by Law and Politics magazine (2010)--a national publication that honors the top lawyers in America.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.

Posted In Medications , Men's Health Issues , Patient Safety , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Shoulder Pain Pumps Destroy Shoulder Joints

Posted by Catherine Bertram   

   
Recognized medical studies show that pain pumps that inject pain medicine right into shoulder joints after surgical procedures are a very likely cause of severe cartilage damage.  The FDA, in November 2009 and again in February 2010 issued a warning about this device.  At the heart of the shoulder pain pump litigation is the fact that continuous infusion pumps were not approved by the FDA for this use.   The pain medication essentially eats away the cartilage in the shoulder joint which is critical to allowing the shoulder to move smoothly without pain and grinding.   The research shows that this permanent injury occurs when an intra-articular pain pump catheter is inserted into the shoulder joint by the surgeon in an effort to reduce the patient's pain, usually after a shoulder surgery.  The catheter then pumps pain medication right into that key joint for several days.    The medical studies show the damage can be inflicted in 2-3 days.  This is a permanent injury and is extremely painful and limiting for the patient. Symptoms include increased pain and stiffness, a clicking or popping or grinding in the shoulder and less motion and loss of strength.  The condition is known as Postarthroscopic Glenohumeral Chrondrolysis (PAGCL).

If you or a family member has this condition and a pain pump was used you may want to consider having the records reviewed and the matter investigated. 
                                                                                       

Continue Reading Posted In Medications , Men's Health Issues , Patient Safety , Pediatrics , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Families of Nearly 3,500 Deceased Vioxx Users Receive Payments From Merck

Posted by: Salvatore J. Zambri, founding partner     

Bloomberg News (7/28, Voreacos, Johnson) reports "Merck & Co. paid claims to the families of 3,468 users of its Vioxx painkiller who died of heart attacks or strokes," a court-appointed administrator told a judge Tuesday. "A $4.85 billion settlement fund made payments to the families of 2,878 Vioxx users who died of heart attacks and 590 who died of strokes," according to the report. Merck "pulled Vioxx from the market in 2004 after a study showed it doubled the risk of heart attacks and strokes."

Well, it is nice to see families of victims obtain justice, but it is nevertheless a shame that so many lives had to have been lost before the dangerous drug was pulled from the market.  Hopefully, the tragic results regarding Vioxx will compel drug companies to focus on safety above profits in the future.

Do you have any questions about this post?

About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri has also been repeatedly named a "Super Lawyer" by Law and Politics magazine (2010)--a national publication that honors the top lawyers in America.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.

Posted In Medications , Men's Health Issues , Patient Safety , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Zinc nasal gels could cause some patients to lose sense of smell.

Posted by: Salvatore J. Zambri, founding partner     

The New York Times (7/26, D6, Rabin) reports "a new analysis has concluded that controversial zinc nasal gel products can cause some patients to lose their sense of smell," according to a study in the Archives of Otolaryngology - Head & Neck Surgery. There is no danger "from taking zinc gluconate orally" but that "when sniffed through the nose it can burn olfactory tissue." The FDA "last year warned consumers to stop using Zicam Cold Remedy Nasal Gel and Zicam Cold Remedy Nasal Swabs," popular "homeopathic remedies that contain zinc." Arizona-based Matrixx Initiatives, which markets them, "has denied the zinc gels cause anosmia and called the conclusions 'scientifically unfounded and misleading.'"

It seems to me that we all should heed the FDA warning.  As with any drug, do not take the zinc gels without first speaking with your doctor.

Do you have any questions about this post?

About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri has also been repeatedly named a "Super Lawyer" by Law and Politics magazine (2010)--a national publication that honors the top lawyers in America.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.

Posted In Medications , Men's Health Issues , Patient Safety , Pediatrics , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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FDA Recall: CONSTELLATION Vision System

CONSTELLATION Vision System is a microsurgical system used to perform various eye surgeries.  This system was recently recalled by the Food and Drug Administration (FDA) due to software and hardware problems associated with:

  • unplanned shutdowns
  • error messages
  • touchscreen malfunctions
  • system setting and infusion performance problems

The FDA warns that these issues may cause eye injuries, including blindness.

The devices recalled were manufactured from September 1, 2008 through April 30, 2010.  The FDA's recall notice includes specific model numbers affected by the recall.

It is recommended that any adverse events or side effects related to this product be reported to the FDA's reporting program.

Posted In U.S. Food and Drug Administration Warnings
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FDA to Conduct Formal Safety Review of ARBs

Posted by: Salvatore J. Zambri, founding partner     


The New Jersey Star-Ledger (7/16, Todd) reports that spurred by a "recently published study," the "Food and Drug Administration is investigating whether some of the most commonly used blood pressure medicines may increase the risks of cancer."

According to the report, the "agency said it began a review of a class of drugs known as angiotensin receptor blockers after a recently published study suggested the medicines could be associated with a slight increased risk of cancer, according to a notice posted on the FDA’s website."

The group of drugs under concern include some of the top-selling blood pressure drugs, such as  Cozaar, which is manufactured by Merck, and Avapro, a Bristol-Myers Squibb drug.

Before taking any medication, please speak with your doctor, who is obligated to inform you of all risks and benefits of the drug prescribes so you can make the best--most informed--decision about your health.

Do you have any questions about this post?

About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri has also been repeatedly named a "Super Lawyer" by Law and Politics magazine (2010)--a national publication that honors the top lawyers in America.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899. 

Posted In Medications , Men's Health Issues , Patient Safety , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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FDA Panel Votes To Keep Avandia On Market With More Restrictions

Posted by: Salvatore J. Zambri, founding partner     

The FDA has not yet removed Avandia from the market, although it is still considering its options.
The New York Times (7/15, A1, Harris) reports on its front page that the 33 panelists "took six votes on a variety of issues" and when asked what the FDA should do, "12 voted that Avandia should be withdrawn; 10 voted that its sales should be restricted and the warnings on its label enhanced; 7 voted only to support enhanced warnings on the drug's label; and 3 voted that the drug should continue to be sold with its present warnings unchanged. One member abstained, and no one voted for a final option, to weaken the label's present heart warnings." Dr. Janet Woodcock, director of the FDA's drug center, "said that the agency took the panel's advice seriously and that it would consider its regulatory options."

The Washington Post (7/15, Stein) reports that a "majority" of the panel urged to keep the drug "available, perhaps with tough new restrictions and warnings." The votes "came after the panel concluded that there was sufficient evidence to be concerned that Avandia increases the risk of heart attacks and strokes but insufficient evidence that the drug increases the risk of death." The panel "also voted to recommend that the FDA allow a large new international study by GlaxoSmithKline, the maker of Avandia, to proceed." Still, the final, "mixed vote illustrated the intensity of the debate over the drug. Critics...argued that the drug was clearly dangerous and unnecessary. Others expressed concern about pulling a drug that might be useful to some diabetics, who frequently need to try more than one medication."

USA Today (7/15, Rubin) also reports that the panel "voted 18-6 that the data raise significant concerns that Avandia carries a higher risk of those heart problems than does Actos [pioglitazone], the only other drug in its class. Nine were undecided."

The Hill 's (7/15, Lillis) Healthwatch blog reports, "Sen. Tom Harkin (D-Iowa), chairman of the Senate Health Committee, is calling on the Food and Drug Administration (FDA) to reach a quick verdict on the fate of Avandia." The Hill also notes that the panel's "mixed verdict puts the ultimate decision in the hands of Margaret Hamburg, who heads the FDA."

Given the serious risks of dangerous drugs, we urge you to speak with your doctor before ingesting any drug.  Be safe.

Do you have any questions about this post?

About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri has also been repeatedly named a "Super Lawyer" by Law and Politics magazine (2010)--a national publication that honors the top lawyers in America.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899. 

Posted In Medications , Men's Health Issues , Patient Safety , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Elan agrees to settle Zonegran probe for $203.5 Million

Posted by: Salvatore J. Zambri, founding partner     

The AP (7/16) reports, "Irish drug maker Elan Corp. PLC said Thursday it agreed to pay $203.5 million to settle investigations into sales and marketing practices related to the epilepsy drug Zonegran [zonisamide]." Elan's US division Elan Pharmaceuticals Inc. "expects to plead guilty to a misdemeanor violation of the Food, Drug and Cosmetic Act," the company said. If the settlement is approved, Elan "said it would resolve all federal and state Medicaid claims into the marketing of Zonegran."

Patients with epilepsy need drugs, but they deserve to know that the marketing and sales practices of the drug-makers are fair, accurate, and properly informative.  Safety and health must be put above profits.  It's a matter of life and death.

 

Do you have any questions about this post?

About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri has also been repeatedly named a "Super Lawyer" by Law and Politics magazine (2010)--a national publication that honors the top lawyers in America.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899. 

Posted In Medications , Men's Health Issues , Patient Safety , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Should Avandia Stay On The Market?

Posted by: Salvatore J. Zambri, founding partner     

There is a great debate over whether Avandia should stay on the market in light of its risks.  The Wall Street Journal urges FDA to keep Avandia on the market. In an editorial, the Wall Street Journal (7/16) says that people who want GlaxoSmithKline's Avandia (rosiglitazone) to be removed from the market, as well those who maintain that it should still be available to patients with type 2 diabetes, were frustrated this week by an FDA advisory panel that voted to keep the drug on the market with tougher restrictions. The Journal notes that the FDA is under immense pressure to remove Avandia from the market, especially from FDA Commissioner Margaret Hamburg's deputy chief Dr. Joshua Sharfstein, but the paper says that, hopefully, Hamburg will keep Avandia available, even just as a backup treatment.

Not everyone shares that view.  One columnist says the collusion between the government and  drugmakers is allowing Avandia to remain on the market.  Jon Carroll wrote in his San Francisco Chronicle (7/14, F8) column that if patients were offered two drugs, one which "has been linked to an increased risk of heart attacks and the other [which] hasn't," they would prefer the latter. He added, "My conclusion is that patients were not given that information by their doctors. My conclusion is that the clammy hand of GSK has urged the doctors to ignore the, ahem, 'flawed and preliminary data' and keep on pushing the Avandia." Carroll argued that despite data suggesting that Avandia may be unsafe, the government is allowing it to remain on the market. He called this "lunacy," and said that there was a "happy collusion between the government, drug companies and (some) private doctors."

Before taking Avandia or any drug, speak to your doctor.  Your doctor is obligated to explain all risks and benefits of drugs he or she prescribes.  If safer drugs are available, they should be considered.

Do you have any questions about this post?

About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri has also been repeatedly named a "Super Lawyer" by Law and Politics magazine (2010)--a national publication that honors the top lawyers in America.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899. 

Posted In Medications , Men's Health Issues , Patient Safety , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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New Law Would Empower FDA To Recall Dangerous Drugs

Posted by: Salvatore J. Zambri, founding partner     

Did you know that the FDA has limited power to recall dangerous drugs?  That's not good, and something needs to be done about it.  Perhaps the time is now.

"[S]purred by questions about Johnson & Johnson's voluntary recall of millions of bottles of children's medicine this spring, a House committee chairman has introduced legislation to give federal regulators the authority to recall drugs that pose health threats," CQ Today (7/16, Ethridge) reports.  House Oversight and Government Reform Chairman Edolphus Towns (D-NY) said Thursday that the bill would give the FDA "the authority to order a recall when a drug has been adulterated or misbranded, or when exposure to the drug would cause serious health consequences or death to humans and animals."

Currently, the FDA can only ask companies to recall their drugs, although it "has the authority to mandate recalls of some products it regulates." This legislation is desperately needed, and has the potential to save lives and keep people from being harmed by defective and dangerous drugs.

Please call your legislators and support this bill.

Do you have any questions about this post?

About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri has also been repeatedly named a "Super Lawyer" by Law and Politics magazine (2010)--a national publication that honors the top lawyers in America.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899. 

Posted In Medications , Men's Health Issues , Patient Safety , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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FDA Discredits Avandia Safety Study

By Catherine Bertram

                                                                                                            

 

Dr. Thomas Marciniak, a reviewer for the U.S. Food and Drug Administration, has sharply critiqued GlaxoSmithKline's clinical trial of Avandia, GlaxoSmithKline's popular diabetes drug.  The study flatly ignored 12 instances of heart problems among the participants.  Studies have demonstrated that Avandia also increases the risk of fractures, swelling, heart attacks, strokes, and death. One patient in the study suffered a brain bleed, but the records of this complication were reportedly deleted.  Another patient spent nine weeks in the hospital for a stroke, but that patient's records apparently did not reflect the catastrophic event.

GlaxoSmithKline's spokesperson was reported as responding by defending the study, “The Record study was conducted according to good clinical practices and the data are reliable.” 

The FDA's safety panel is meeting this week to decide whether Avandia, which had sales of $3.2 billion in 2006, should be pulled from the market or whether the warnings need to be strengthened regarding the complications associated with this medication. 

 

Posted In U.S. Food and Drug Administration Warnings
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New Evidence that Avandia Manufacturer Hid Test Results

Posted by: Salvatore J. Zambri, founding partner     

Last week, I posted a blog entry about the controversy surrounding Avandia after recent studies revealed the cardiovascular dangers surrounding it and advised readers to contact their doctor immediately regarding possible alternative medication. 

A new article in the New York Times provides more insight into the known problems with Avandia at SmithKline Beecham.  According to studies conducted by the manufacturer in 1999, signs were evident that Avandia was riskier to the heart; however, the company chose not to publish those studies, instead spending 11 years trying to cover them up.  "The company did not post the results on its Web site or submit them to federal drug regulators, as is required in most cases by law."  Following the May, 2007 lawsuit that forced SmithKline (successor to SmithKline Beecham) to post some documents on its website, it has become more obvious that the company aggressively attempted to prevent the public from learning of the cardiovascular safety risks to protect their sales numbers.

Continue Reading Posted In Medications , Men's Health Issues , Patient Safety , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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FDA WARNING: Qualaquin unapproved for use for night leg cramps due to serious side effects

By Catherine Bertram

The FDA issued a warning this week due to continued reports of serious side effects in patients using Qualaquin "off-label" for night time leg cramps, it states in part as follows "FDA has approved a risk management plan to warn against the use of this drug for such unapproved uses. Qualaquin should not be used for night time leg cramps. Qualaquin use may result in serious and life-threatening hematological reactions, including serious bleeding due to thrombocytopenia, and hemolytic-uremic syndrome/ thrombotic thrombocytopenic purpura, which in some cases may result in permanent kidney damage. In some patients, adverse reactions result in hospitalization and death.

Qualaquin is only FDA-approved for the treatment of uncomplicated malaria caused by the parasite Plasmodium falciparum, primarily in travelers returning from malaria-endemic areas. However, the majority of Qualaquin's use in the United States is for the treatment or prevention of night time leg cramps.The product labeling states that the risks associated with the use of Qualaquin in the absence of evidence of its effectiveness for treatment or prevention of nocturnal leg cramps outweigh any potential benefits.


The risk management plan (REMS) requires that patients be given a Medication Guide explaining what this medication is and is not approved for, as well as the potential side effects of this drug. In addition, the REMS requires that the manufacturer issue a Dear Health Care Provider Letter warning of the risk of serious and life-threatening hematologic reactions.


THE FDA RECOMMENDATION: Healthcare professionals should discuss with patients the warning signs of thrombocytopenia, such as easy bruising, severe nose bleeds, blood in the urine or stool, bleeding gums, and the appearance of unusual purple, brown, or red spots on the skin.

Posted In Men's Health Issues , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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FDA WARNING: QUE SHE WEIGHT LOSS SUPPLEMENT CONTAINS DRUGS

 By Catherine Bertram

 

The FDA warned consumers and healthcare professionals today that "Que She, marketed as an herbal weight loss supplement, contains unlisted and active pharmaceutical ingredients that could harm consumers, especially those with cardiovascular conditions. These active pharmaceutical ingredients also may interact with other medications and result in a serious adverse event.

Que She, advertised as “Slimming Factor Capsule” and as “an all-natural blend of Chinese herbs,” has been widely distributed on Internet sites such as the Bouncing Bear Botanicals website, and at retail outlets, including Sacred Journey in Lawrence, Kansas."

FDA analysis of Que She found that it contains:
   
o    fenfluramine – a stimulant drug withdrawn from the U.S. market in 1997 after studies demonstrated that it caused serious heart valve damage
o    propranolol – a prescription beta blocker drug that can pose a risk to people with bronchial asthma and certain heart conditions
o    sibutramine – a controlled substance and prescription weight loss drug, sibutramine was the subject of a recent study whose preliminary findings showed an association between sibutramine use and increased risk of heart attack and stroke in patients who have a history of heart disease
o    ephedrine – a stimulant drug that is legally marketed over-the-counter for temporary relief of asthma but can pose a risk to people with certain cardiovascular conditions.

The FDA recommends that people who have purchased Que She should stop taking the product immediately and consult a health care professional.

 

Continue Reading Posted In Medications , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Should Patients Seek Alternatives To Avandia?

Posted by: Salvatore J. Zambri, founding partner     


The New York Times (7/5) editorialized that the recent controversy over the diabetes drug Avandia -- with "two major studies" saying it "raises the risk of cardiovascular ailments" and the third yet-to-be-published study that "seemed to exonerate" the drug -- should probably lead patients to ask their doctors about alternatives. The paper said that as expert advisers to the Food and Drug Administration work to deliver a more definitive judgment, it would throw its lot with the views of safety specialists, who focus solely on risks emerging after the drug is in use, rather than the opinions of those "who approved the drug as safe and effective in the first place.

If you or a loved one uses Avandia, you are encouraged to speak to your doctor immediately.  Your doctor should inform you of all risks associated with any drug he or she prescribes, so that you can make fully informed health decisions.

Do you have any questions about this post?  

About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area.  The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims.  Mr. Zambri has also been repeatedly named a "Super Lawyer" by Law and Politics magazine (2010)--a national publication that honors the top lawyers in America.  

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.

Posted In Medications , Men's Health Issues , Patient Safety , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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FDA Claims Cornerstone Withheld Risks of Asthma Drug

 Posted by: Salvatore J. Zambri, founding partner     


The AP (7/7) reports, "The Food and Drug Administration said Tuesday it sent a warning letter to Cornerstone Therapeutics Inc. alleging that Cornerstone's promotional materials withheld information about the risks of its asthma drug Zyflo CR [zileuton]." The FDA "said the materials violated the Food, Drug, and Cosmetic Act" by using "outdated labeling" and suggesting "Zyflo CR is more effective than competing drugs like Singulair [montelukast]." In addition, the agency "said a Cornerstone visual aid did not include warnings about the most serious side effects or the most common ones."

While I appreciate the desire to sell products, it is critically important for drug companies to inform customers and the public generally of the risks associated with the use of their drugs. It is often a matter of life and death.  Safety and people should always trump profits.

 

Do you have any questions about this post?  

About the author:

Mr. Zambri is a Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area.  The magazine also acknowledges him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims.  Mr. Zambri has also been repeatedly named a "Super Lawyer" by Law and Politics magazine--a national publication that honors the top lawyers in America.  

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.

 


 

Posted In Medications , Men's Health Issues , Patient Safety , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis

By Catherine Bertram

Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN) are serious disorders in which your skin and mucous membranes react severely to a medication or infection. Often, Stevens-Johnson syndrome begins with flu-like symptoms, followed by a painful red or purplish rash that spreads and blisters, eventually causing the top layer of your skin to die and shed.

SJS usually begins with fever, sore throat, and fatigue, which can be initially misdiagnosed. Ulcers and other lesions begin to appear in the mucous membranes, almost always in the mouth and lips but also in the genital and anal regions. Those in the mouth are usually extremely painful and reduce the patient's ability to eat or drink.

SJS is most often caused by  of medication. The leading cause appears to be use of antibiotics and sulfa drugs.    Although SJS can be caused by viral infections.

Medication causes

Drugs commonly associated with Stevens-Johnson syndrome include:

  • Anti-gout medications, such as allopurinol
  • Nonsteroidal anti-inflammatory drugs (NSAIDs)
  • Sulfonamides and penicillins, which are used to treat infections
  • Anticonvulsants, which are used to treat seizures
Continue Reading Posted In Medical Malpractice , Medications , Men's Health Issues , Patient Safety , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Physicians urge limits on CT scan radiation exposure

By Catherine Bertram                                                  

Several articles in a recent issue of the New England Journal of Medicine call for increased regulation of the use of  x-ray computed tomography, or CT scans. The procedure can exposes patients to often unnecessary and/or concerning levels of radiation.

The FDA regulates CT scanners but does not require physicians to use the machines in a particular way or limit  the amount of radiation patients are exposed to.   A CT scan normally exposes a patient to 100 to 200 times the radiation from a standard chest x-ray. A 2007 study by Columbia University estimates that these CT scans may lead to a very small increase (2%) of all cancer cases down the line.

Continue Reading Posted In Medical Malpractice , Patient Safety , U.S. Food and Drug Administration Warnings
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FDA Unaware of Companies' Foreign Drug Trials

Posted by: Salvatore J. Zambri, founding partner

In a story appearing on over 100 news websites, the AP (6/23, Perrone) reports that the FDA "is reviewing only a fraction of foreign drug trials, as companies increasingly move drug testing overseas to reduce costs." According to a report issued Tuesday by the Inspector General for HHS, the FDA "inspected about one percent of foreign drug testing sites in fiscal year 2008," and is "often unaware" of "early-stage trials conducted in developing countries" in "South and Central America." The report also makes several recommendations to help the FDA oversee foreign studies, including developing "better coordination with foreign governments to monitor drug trials abroad," and requiring drugmakers "to submit trial data in a standardized electronic format, to help the FDA identify sites for inspection."

If companies are going to rely on foreign drug trials, they must alert the FDA about such trials and afford the agency the time and access to inspect and evaluate the trials.  The FDA, for their part, must diligently inspect the foreign sites.  Of course, drug companies are ultimately responsible for their drugs, not the FDA, although the FDA does have its obligations.  No drug should enter the marketplace unless it is safe and sufficiently tested.  Safety must always trump profits. 

 

 

Do you have any questions or comments about this post?  

About the author:

Mr. Zambri is a Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area.  The magazine also acknowledges him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, serious automobile accident claims, and other personal injury actions.  Mr. Zambri has also been repeatedly named a "Super Lawyer" by Law and Politics magazine--a national publication that honors the top lawyers in America.  

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.

Posted In Medications , Men's Health Issues , Patient Safety , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Pfizer Withdraws Mylotarg From US Market

Posted by: Salvatore J. Zambri, founding partner

The Wall Street Journal (6/22, Dooren) reports that the FDA has announced that Pfizer Inc. has withdrawn Mylotarg (gemtuzumab ozogamicin) from the US market following research indicating that the medication was not effective and was linked to safety issues. The AP (6/22, Perrone) reports that the drug "carries a warning label about a sometimes fatal liver condition called veno-occlusive disease. The FDA said the rate of reports of the disease associated with the drug increased during its time on the market."

If you are taking this drug, please contact your doctor immediately.  Your physician is obligated to inform you of all known risks and benefits of a drug so you can make the best--most informed--health decisions.

Do you have any questions or comments about this post?  

About the author:

Mr. Zambri is a Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area.  The magazine also acknowledges him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, serious automobile accident claims, and other personal injury actions.  Mr. Zambri has also been repeatedly named a "Super Lawyer" by Law and Politics magazine--a national publication that honors the top lawyers in America.  

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.

Posted In Medications , Men's Health Issues , Patient Safety , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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FDA Warning: Counterfeit Tamiflu

The Food and Drug Administration (FDA) has released a report about the sale of Generic Tamiflu over the internet. Tamiflu, a drug used for the treatment of patients with illness due to influenza that contains the active ingredient oseltamivir, has been sold through websites claiming to be online drug stores.  The Generic Tamiflu that is being sold through these websites has cloxacillin as its active ingredient, which belongs to the same class of antibiotics as penicillin.  Patients who are allergic to penicillin will possibly see a similar life-threatening anaphylactic reaction to cloxacillin, including the following symptoms:

  • Labored/Difficult breathing
  • Chest tightness
  • Swelling of the throat/tongue
  • Dizziness
  • Hives
  • Loss of consciousness
  • Rapid or weak pulse

The FDA advises patients that possess or come across the counterfeit Tamiflu to discontinue use and contact the FDA's Office of Criminal Investigations.

Continue Reading Posted In Medical Malpractice , Medications , Product Liability , U.S. Food and Drug Administration Warnings
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FDA Tylenol & Benadryl Recall Update

Yesterday, Johnson & Johnson announced the recall of five additional lots of over-the-counter medications that were inadvertently omitted from a January 15, 2010 recall of similar products. The latest recall involves four lots of BENADRYL® Allergy ULTRATAB™ 100 COUNT pills and one lot of TYLENOL® EXTRA STRENGTH RAPID RELEASE GELCAP 50CT, both manufactured by McNeil Consumer Healthcare, a subsidiary of Johnson & Johnson.

If you have purchased any of the products involved, you are advised to stop using them immediately.

Find detailed information about the recall and how to obtain a refund HERE, or for information on all McNeil recalls, see their product recall homepage.

For related information on recalls and medication disposal, please feel free to read the DC Area Medical Malpractice Law Blog's posting on recent McNeil recalls.

Posted In Medications , Patient Safety , U.S. Food and Drug Administration Warnings
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FDA Warns Pfizer on failure to report drug complaints.

Posted by: Salvatore J. Zambri, founding partner

According to an AP report, the Food and Drug Administration issued a warning letter to "Pfizer Inc. for failing to promptly report complaints with its drugs that may have involved serious injury." In the 12-page letter, dated May 26, the FDA "cites a number of product complaints which were not reported to government regulators within the required 15 days." The letter also "demands that Pfizer submit a plan for correcting the problems within 15 business days."

The Wall Street Journal also reports that this FDA warning letter to Pfizer is the second one this year. Two months ago, the company received an agency warning regarding pediatric clinical trials of the antipsychotic Geodon (ziprasidone). The Journal points out that the latest warning results from a 2009 inspection of Pfizer's headquarters, an inspection which the agency said was to ascertain Pfizer's compliance with reporting rules regarding adverse events after drugs are allowed on the market. Specifically, the letter said the agency discovered that some adverse-event reports were not actually reported until after its inspection was conducted. The drugs involved were Lyrica (pregabalin) and Lipitor (atorvastatin).

Per a Reuters report, the Food and Drug Administration has asked to meet with Pfizer to discuss the violations. For its part, Pfizer promised to work with the FDA to address and remedy the problems.

Obviously, we need medication to maintain and promote health.  However, it is critically important for pharmaceutical companies to accurately and timely report the dangers of the drugs they make and sell, so that doctors and patients can properly evaluate the risks and benefits of the drugs.  Safety must always trump profits.

 

Do you have any questions or comments about this post?  

About the author:

Mr. Zambri is a Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area.  The magazine also acknowledges him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, serious automobile accident claims, and other personal injury actions.  Mr. Zambri has also been repeatedly named a "Super Lawyer" by Law and Politics magazine--a national publication that honors the top lawyers in America.  

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899. 

Posted In Medications , Men's Health Issues , Patient Safety , Product Liability , U.S. Food and Drug Administration Warnings , Women's Health Issues
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FDA Recalls and Medicine Safety

Over the weekend, four PediaCare brands of children's medicines became the most recent additions to a string of recalls stemming from Johnson & Johnson's McNeil plant in Fort Washington, Pennsylvania. Four PediaCare products joined the long list of child and infant liquid formulations of Tylenol, Motrin, Zyrtec, and Benadryl that had previously been recalled.

According to WebMD, the newly recalled PediaCare brands are as follows:
    * PediaCare Multi-Symptom Cold 4oz. UPC # 3 0045-0556-05 9
    * PediaCare Long Acting Cough 4oz. UPC# 3 0045-0465-04 7
    * PediaCare Decongestant 4oz. UPC# 3 0045-0554-04 8
    * PediaCare Allergy and Cold 4oz. UPC# 3 0045-0552-04 4

To see the complete list of Tylenol, Motrin, Zyrtec, and Benadryl products involved in the original recall, or to request a refund online, see McNeil’s recall page. The Food and Drug Administration’s (FDA’s) explanation of the recall can be found here, or in a helpful PDF brochure.

Continue Reading Posted In Medications , Pediatrics , U.S. Food and Drug Administration Warnings
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Proton Pump Inhibitors Can Cause Bone Fractures

Posted by: Salvatore J. Zambri, founding partner

The FDA has warned that Proton Pump Inhibitors can cause bones to fracture when used for more than one year or prescribed in higher doses.  According to ABC World News, as reported by CBS Evening News , "high doses or long-term use of what are called proton pump inhibitors can lead to an increased risk of bone fractures." This is especially true in patients "over the age of 50," and for "people on the high dose," says NBC Nightly News.

Before taking any medication, please speak with your doctor to be sure the benefits of the drug outweigh the risks.  Your doctor is obligated to explain all risks and benefits to you so that you can make the most informed decision possible about your health.  If not monitored appropriately, certain medications can cause serious, even life-threatening, consequences.

 

Do you have any questions or comments about this post?  

About the author:

Mr. Zambri is a Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area.  The magazine also acknowledges him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, serious automobile accident claims, and other personal injury actions.  Mr. Zambri has also been repeatedly named a "Super Lawyer" by Law and Politics magazine--a national publication that honors the top lawyers in America.  

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899. 

Posted In Medications , Men's Health Issues , Patient Safety , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Nurse Interruptions, Distractions Lead To Medical Errors

Posted by: Salvatore J. Zambri, founding partner 

As reported recently by a HealthDay report, Patient Safety and Quality Healthcare article and Archives of Internal Medicine abstract, distractions and interruptions for nurses during medication preparation and administration lead to a higher rate of procedural failures and clinical errors.  Although patient safety experts have warned about these dangers for a number of years, this is the first research to actually confirm that relationship. Common distractions include staff inquiries, stopping to search for missing drugs or supplies, and responding to phone calls or pages.  According to Patient Safety and Quality Healthcare Reports, nurses view these types of interruptions as part of the daily work and don't seek to control them--a scary thing.

Following are significant observations from the study:

  • "Errors were classified as either "procedural failures," such as failing to read the medication label, or "clinical errors," such as giving the wrong drug or wrong dose.
  • Only one in five drug administrations (19.8 percent) was completely error-free, the study found.
  • Interruptions occurred during more than half (53.1 percent) of all administrations, and each interruption was associated with a 12.1 percent increase, on average, in procedural failures and a 12.7 percent increase in clinical errors.
  • Most errors (79.3 percent) were minor, having little or no impact on patients, according to the study. However, 115 errors (2.7 percent) were considered major errors, and all of them were clinical errors.
  • Failing to check a patient's identification against his or her medication chart and administering medication at the wrong time were the most common procedural and clinical glitches, respectively, the study reported."

"Nurses reported that study observations were made during a comparatively non-chaotic days when they had not been working extremely busy shifts. Investigators felt that if the nurses had been observed during a more intensely busy shift, more errors would have been seen."  The value of this new study "lends important evidence to identifying the contributing factors and circumstances that can lead to a medication error," said Carol Keohane, Program Director for the Center of Excellence for Patient Safety Research and Practice at Brigham and Women's Hospital in Boston.

Several hospitals have recommended possible means to avoid excessive interruptions, such as "no interruption zones," "do not disturb vests," "medication pass time-out," or "protected hour" for medication administration.  This issue must be taken seriously by hospitals and other medical facilities otherwise serious medical errors will continue to occur.  According to the reputed Institutes of Medicine, approximately 98,000 Americans are killed every year as a result of medical errors.  Patient safety needs to be a priority.

Do you have any questions about this post?  

 

About the author:

Mr. Zambri is a Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area.  The magazine also acknowledges him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims.  Mr. Zambri has also been repeatedly named a "Super Lawyer" by Law and Politics magazine--a national publication that honors the top lawyers in America.  

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.

Posted In Medications , Men's Health Issues , Nursing Home Negligence , Patient Safety , Pediatrics , Public Health , U.S. Food and Drug Administration Warnings
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Sedative Vials Too Large, Doctor Testifies

Posted by: Salvatore J. Zambri, founding partner               

                                                                                                        

The Las Vegas Review-Journal reports that an anesthesiologist testified that "the 50-milliliter vials of anesthetic linked to a hepatitis C outbreak would have been enough to knock out a 600 pound gorilla during a colonoscopy," in the trial of Henry Chanin who was infected with hepatitis C during a 2006 colonoscopy in a Southern Nevada clinic. Chanin is suing Teva Parenteral Medicine and Baxter Healthcare Services on product liability issues claiming that "the companies made and sold vials of propofol that were much larger than needed for colonoscopies, which tempted medical workers to reuse vials among patients instead of throwing away unused anesthetic."

Hospitals and doctors should never reuse vials.  Doing so clearly and seriously threatens the health of patients.  We hope a lesson is learned here, although for many Americans it is too late, as they have suffered terrible health problems from the apparent misuse of the vials.

 

Do you have any questions or comments about this post?  

About the author:

Mr. Zambri is a Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area.  The magazine also acknowledges him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims.  Mr. Zambri has also been repeatedly named a "Super Lawyer" by Law and Politics magazine--a national publication that honors the top lawyers in America.  

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899. 

Posted In Medications , Men's Health Issues , Patient Safety , Pediatrics , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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FDA Warns Pfizer About Insufficient Oversight During Clinical Trial Involving Children

Posted by: Salvatore J. Zambri, founding partner               

                                                                                                        

The AP reports that in a warning letter dated April 9 and posted online April 20, the Food and Drug Administration said that Pfizer "has failed to correct problems with its testing procedures that resulted in overdoses of several children during a company trial" of "an experimental medication, which the agency did not name." However, a company spokeswoman said that medicine "is Geodon [ziprasidone], which the company was studying for children with bipolar disorder."

Bloomberg News reports that the letter posted to the agency's website outlined "'significant violations' discovered during an inspection of a Pfizer clinical trial site from May 4 to June 3." In 2005, the FDA warned Pfizer about the "lack of study monitoring that led to widespread overdoses," and "follow-up inspections in 2006 and 2007 also found dosing errors, the FDA said." The FDA has ordered Pfizer "to respond within 15 days with a plan to ensure that its studies comply with federal regulations."

The Wall Street Journal/Dow Jones Newswire reports that Pfizer is currently seeking agency approval of Geodon to treat bipolar disorder in patients ranging in age from 10 to 17 years old, which the FDA declined to do six months ago, citing a need for more information. The medication is currently approved for the treatment of schizophrenia and bipolar disorder in adult patients, however. Meanwhile, the Journal quotes Pfizer as stating that it "recognizes the seriousness of the issues cited by the FDA and is committed to fully addressing FDA's concerns."

Reuters reports that even though 13 children suffered from overdosing during the clinical trial, none was injured or subjected to ongoing side effects, and only two youngsters had to be taken out of the clinical trial. Since the overdosing incidents, seven found by the FDA and six documented in the pharmaceutical company's own internal memoranda, Pfizer said it "has instituted several new measures designed to improve monitoring and execution of clinical trials, including our oversight of clinical investigators."

Medications for children are necessary.  But so is safety.  In an effort to create effectove drugs, companies should never risk the health of those utilized in a clinical trial.  Safety over profit must be the goal.

Do you have any questions about this post?  

About the author:

Mr. Zambri is a Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area.  The magazine also acknowledges him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims.  Mr. Zambri has also been repeatedly named a "Super Lawyer" by Law and Politics magazine--a national publication that honors the top lawyers in America.  

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.

Posted In Medications , Men's Health Issues , Patient Safety , Pediatrics , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Antidepressants May Similarly Affect Suicide Risk In Children, Adolescents

Posted by: Salvatore J. Zambri, founding partner               

                                                                                                        

HealthDay reported that, according to a study published in the journal Pediatrics, "there appears to be no difference among antidepressants in raising a kid's risk of suicidal thoughts." Harvard School of Public Health researchers "collected data on 20,906 children aged 10 to 18 who had been diagnosed with depression in British Columbia," after following the children for nine years. The young participants "were on a variety of commonly prescribed antidepressants called selective serotonin reuptake inhibitors (SSRIs), including citalopram (Celexa), fluoxetine (Prozac), fluvoxamine (Luvox), paroxetine (Paxil), and sertraline (Zoloft)."

Medscape reported, "During the first 12 months of treatment, the researchers identified 266 attempted and three completed suicides -- an event rate of 27.04 suicidal acts per 1000 person-years (95% confidence interval [CI], 23.9 – 30.5 suicidal acts per 1,000 person-years)." However, "they failed to see any significant differences in rate ratios (RRs) in analyses comparing fluoxetine with citalopram (RR, 0.97; 95% CI, 0.54 – 1.76), fluvoxamine (RR, 1.05; 95% CI, 0.46 – 2.43), paroxetine (RR, 0.80; 95% CI, 0.47 – 1.37), and sertraline (RR, 1.02; 95% CI, 0.56 – 1.84)."

Reuters interviewed Thomas Laughren, MD, director of the FDA's Division of Psychiatry Products, who pointed out that clinicians need to closely follow young people on antidepressants due to the increased risk for suicide.

These reports underscore the importance of carefully monitoring people, especially young people, who are prescribed antidepressants.  Doctors must be aware of all risks and benefits attendant to the drugs they prescribe, and must explain those risks and benefits to patients and, when appropriate, parents and guardians, so that the best medical decisions can be made.

do you have any questions about this post?  

About the author:

Mr. Zambri is a Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area.  The magazine also acknowledges him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims.  Mr. Zambri has also been repeatedly named a "Super Lawyer" by Law and Politics magazine--a national publication that honors the top lawyers in America.  

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.

Posted In Medications , Men's Health Issues , Patient Safety , Pediatrics , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Stalevo May Increase Prostate Cancer Risk, Says FDA

Posted by: Salvatore J. Zambri, founding partner               

CONTACT US  

                                                                                                        

Bloomberg News reported that "Novartis AG and Orion Oyj's Stalevo treatment for Parkinson's disease may be linked to an increased risk of prostate cancer, US health regulators said." In a statement found on its website, the FDA states that its "review of Stalevo is ongoing, and no new conclusions or recommendations about the use of this drug have been made." The agency "is reviewing a clinical trial that showed that prostate cancer was more common among patients taking Stalevo than in those taking only a combination of carbidopa and levodopa."

If you have been prescribed Stalevo, we encourage you to speak to your doctor promptly about all potential risks and benefits.  Your doctor is obligated to provide this information to you so that you can make the best, most informed, decisions possible concerning your health. 

I'll report back once we learn more about the FDA's review of the clinical trial.  In the meantime, if you have any questions at all, please feel free to contact me.

CONTACT ME  

About the author:

Mr. Zambri is a Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area.  The magazine also acknowledges him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims.  Mr. Zambri has also been repeatedly named a "Super Lawyer" by Law and Politics magazine--a national publication that honors the top lawyers in America.  

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899. 

Posted In Cancer Misdiagnosis , Men's Health Issues , Patient Safety , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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"Experts" Supporting Avandia Drug Had Financial Ties To Drugmaker

Posted by: Salvatore J. Zambri, founding partner

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Bloomberg News (BN) recently reported that, according to the Mayo Clinic, "Most scientists who published articles supporting GlaxoSmithKline Plc's diabetes drug Avandia [rosiglitazone] after it was linked to heart disease in 2007 had financial ties to the company."  

The United Kingdom's Independent reported, "Researchers from the Mayo Clinic in Minnesota -- one of the few US research organizations that does not rely on commercial sponsorship -- analyzed more than 200 articles published in scientific journals, including original papers, editorials, and letters, which commented on the heart attack risk associated with Avandia after 2007. " The investigators "found almost half (47 percent) of the study authors had financial conflicts of interest, but almost a quarter (23 percent) did not disclose it. They were discovered by searching other publications by the same author or on the Internet."

In February, internal documents and findings from the Food and Drug Administration, released by US Senators, made the recommendation that Avandia should be removed from the American market. The agency now plans to conduct a July meeting to weigh the pros and cons of the drug.

I blogged about the Avandia drug earlier this year.  To read that blog and learn more about the risks of Avandia, please click here.

If prescribed Avandia, please contact your doctor immediately.  Your doctor should not prescribe any medication without first warning you of all known risks, and only if the benefits of the medication outweigh the risks.

CONTACT ME  

About the author:

Mr. Zambri is a Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area.  The magazine also acknowledges him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims.  Mr. Zambri has also been repeatedly named a "Super Lawyer" by Law and Politics magazine--a national publication that honors the top lawyers in America.  

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

Mr. Zambri was sought after to publish a chapter regarding product liability litigation in Aspatore Books - a company that is touted as "the largest and most exclusive publisher of C-1 Level executives (CEO, CFO, CTO, CMO, Partner) from the world's most respected companies and law firms."  To read Mr. Zambri's publication, entitled "Constantly Preparing To Win", please click here.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.   

Posted In Medications , Men's Health Issues , Patient Safety , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Drug Company Alpharma Pays $42.5Mill To Settle Suit Alleging Misrepresentation

Posted by: Salvatore J. Zambri, founding partner

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According to the Wall Street Journal, the Justice Department has announced that Alpharma, Inc. has agreed to pay a whopping $42.5 Million to settle a claim in which the government alleged that the drug company improperly paid physicians to prescribe and promote a particular morphine drug--Kadian.  The settlement follows a whistle-blower suit.

Whistle-blower suits allow people who work for companies to come to the government with evidence that the companies are violating the law.  These kinds of suits are important as they provide protection to the whistle-blower while the government intervenes and remedies an injustice.

People who are aware of corporate wrongdoing understandably feel like they have a moral and ethical obligation to come forward in an effort to stop the injustice.  They often don't, however, fearing that they will be retaliated against.  These whistle-blowers are protected by the law, however.  If you are aware of corporate misfeasance, feel free to contact me to discuss your rights.  Never feel powerless.

About the author:

Mr. Zambri is a Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area.  The magazine also acknowledges him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims.  Mr. Zambri has also been repeatedly named a "Super Lawyer" by Law and Politics magazine--a national publication that honors the top lawyers in America.  

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

Mr. Zambri was sought after to publish a chapter regarding product liability litigation in Aspatore Books - a company that is touted as "the largest and most exclusive publisher of C-1 Level executives (CEO, CFO, CTO, CMO, Partner) from the world's most respected companies and law firms."  To read Mr. Zambri's publication, entitled "Constantly Preparing To Win", please click here.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.   

Posted In Medications , Men's Health Issues , Patient Safety , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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FDA Forces Drugmakers to Stop Selling Unapproved Nitrogylcerin Tablets

Posted by: Salvatore J. Zambri, founding partner     

New Jersey's Star-Ledger reports that the FDA on Tuesday ordered "Glenmark Generics to stop selling unapproved nitroglycerin tablets for relief from chest pain." The unapproved drugs "are different from approved nitroglycerin tablets in some ways, such as formulation and labeling, but the FDA said it has seen quality and efficacy problems with the unapproved versions." The FDA also "advised consumers that Pfizer sells a version of the product that has been approved by regulators." Kotec Inc. of Arizona also received a warning.

According to the Los Angeles Times' "Booster Shots" blog, the FDA gave the two drugmakers "90 days to stop making and selling nitroglycerin tablets for use by heart patients and 180 days to stop shipping those they have made." Reuters also covers the story.

There is great danger in selling unapproved drugs.  Drug companies must always put the safety of people over profits.  If they don't, their greed will seriously injure and even kill Americans. 

Before taking any medication, be sure to consult with your doctor, who is obligated to provide you with all risks and benefits of the drug before prescribing the medication.

About the author:

Mr. Zambri is a Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. and has been rated by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all lawyers in the Washington metropolitan area.  The magazine also describes him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims.  Mr. Zambri has also been repeatedly named a "Super Lawyer" by Law and Politics magazine--a national publication that honors the top lawyers in America.  

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

Mr. Zambri was sought after to publish a chapter regarding product liability litigation in Aspatore Books - a company that is touted as "the largest and most exclusive publisher of C-1 Level executives (CEO, CFO, CTO, CMO, Partner) from the world's most respected companies and law firms."  To read Mr. Zambri's publication, entitled "Constantly Preparing To Win", please click here.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.  
 

Posted In Medications , Men's Health Issues , Patient Safety , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Similar Drug Names and Bottles Cause Major Mistakes

Posted by: Salvatore J. Zambri, founding partner     


ABC World News recently reported on how some drug bottles look alike and how the United States Food and Drug Administration (FDA) "said it gets thousands of reports of such mix-ups every year." The FDA's Dr. Gerald Pan said, "Today's near-miss, today's medication error that doesn't cause harm to somebody could cause harm to someone tomorrow." ABC noted the name-change for Kapidex (dexlansoprazole) last week, but "that still leaves several hundred sound-alike and lookalike drug combinations to go."

Many scholars believe drug companies mirror other companies' products in an effort to fool customers into purchasing their products.  Here's what is important:  never buy a drug unless you are absolutely sure you know what you are purchasing.  Also, doctors and medical staff should never provide drugs to patients without understanding all risks and benefits of the drug and without first confirming that the drug provided to the patient is what the doctor has in fact prescribed.

 

About the author:

Mr. Zambri is a Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. and has been rated by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all lawyers in the Washington metropolitan area.  The magazine also describes him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims.  Mr. Zambri has also been repeatedly named a "Super Lawyer" by Law and Politics magazine--a national publication that honors the top lawyers in America.  

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

Mr. Zambri was sought after to publish a chapter regarding product liability litigation in Aspatore Books - a company that is touted as "the largest and most exclusive publisher of C-1 Level executives (CEO, CFO, CTO, CMO, Partner) from the world's most respected companies and law firms."  To read Mr. Zambri's publication, entitled "Constantly Preparing To Win", please click here.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.  

Posted In Medications , Men's Health Issues , Patient Safety , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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KV Pharmaceutical reaches $27 million settlement with Justice Department

 Posted by: Salvatore J. Zambri, founding partner     


The AP reported that "Drugmaker KV Pharmaceutical Co. says it will shut down its Ethex generic division, plead guilty to criminal charges" that the company failed to immediately notify "regulators of safety hazards."  The embattled company will "pay $27.6 million to resolve government investigations," according to the report.

The settlement requires Ethex to "plead guilty to two felony counts for failing to file 'field alerts' for two drugs, dextroamphetamine and propafenone," the St. Louis Post-Dispatch reports. In addition, "KV was ordered to stop making some time-release cough, cold, and gastrointestinal drugs in 2008," but despite that order, "the FDA said KV continued to make the drugs."

This smacks as another instance in which a big company decided to mock the law and put profits over safety.  There is no place for such greed in this country.  I hope the criminal consequences send a message to all greedy executives that they better change the way they do business and start putting people over profits.  Americans shouldn't be seriously injured or killed just so executives can pad their pockets.

About the author:

Mr. Zambri is a Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. and has been rated by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all lawyers in the Washington metropolitan area.  The magazine also describes him as "one of Washington's best--most honest and effective lawyers" who specializes in personal injury matters, including product liability, medical malpractice, and automobile accident claims.  Mr. Zambri has also been named a "Super Lawyer" by Super Lawyer magazine (March/April 2009)--a national publication that honors the top lawyers in America.  

Mr. Zambri was sought after to publish a chapter regarding product liability litigation in Aspatore Books - a company that is touted as "the largest and most exclusive publisher of C-1 Level executives (CEO, CFO, CTO, CMO, Partner) from the world's most respected companies and law firms."  To read Mr. Zambri's publication, entitled "Constantly Preparing To Win", please click here.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.  

Posted In Medical Malpractice , Medications , Men's Health Issues , Patient Safety , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Avandia Linked to Heart Attacks, Death Per Senate Report

 Posted by: Salvatore J. Zambri, founding partner     

The front page of the New York Times reported that "Hundreds of people taking Avandia [rosiglitazone], a controversial diabetes medicine, needlessly suffer heart attacks and heart failure each month, according to confidential government reports." A Senate Finance Committee review cites internal FDA documents that highlight a dispute among regulators that "has been brewing for years but has been brought to a head by disagreement over a new clinical trial."

The Wall Street Journal reports that the Senate committee concluded that Glaxo was aware of the risks, but minimized the issue and attempted to suppress concerned physicians. The FDA's documents also indicate that agency scientists said the drug should be pulled from the market in 2008, but FDA chiefs rejected the recommendations. Now, agency commissioner Margaret Hamburg is expected to meet "with FDA scientists and outside experts to gain a full understanding...of all of the data and issues involved," a spokeswoman said.

The AP reported that the Senate committee is asking the FDA "why it allowed a clinical trial of Avandia to continue even after the agency estimated that the drug caused 83,000 heart attacks between 1999 and 2007." Glaxo agreed to an FDA request for "a six-year study between its drug and" the Pfizer diabetes drug Actos [pioglitazone] "to give a definitive picture of Avandia's safety."

If the senate report proves to be accurate, this once again smacks of a company putting profits over patient safety, leading to serious injuries and death.

If prescribed Avandia, please contcat your doctor immediately.  Your doctor should not prescribe any medication without first warning you of all known risks, and only if the benefits of teh medication outweigh the risks.

About the author:

Mr. Zambri is a Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. and has been rated by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all lawyers in the Washington metropolitan area.  The magazine also describes him as "one of Washington's best--most honest and effective lawyers" who specializes in personal injury matters, including product liability, medical malpractice, and automobile accident claims.  Mr. Zambri has also been named a "Super Lawyer" by Super Lawyer magazine (March/April 2009)--a national publication that honors the top lawyers in America.  

Mr. Zambri was sought after to publish a chapter regarding product liability litigation in Aspatore Books - a company that is touted as "the largest and most exclusive publisher of C-1 Level executives (CEO, CFO, CTO, CMO, Partner) from the world's most respected companies and law firms."  To read Mr. Zambri's publication, entitled "Constantly Preparing To Win", please click here.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.   

Posted In Medical Malpractice , Men's Health Issues , Patient Safety , Pediatrics , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Two Million Defective Huber Needles Recalled by Nipro

 Posted by: Salvatore J. Zambri, founding partner     


The AP (1/27, Perrone) reports, "Federal health officials announced the recall of two million medical needles Tuesday because of a risk they can push bits of silicone into patients' bodies." The FDA "said Japanese manufacturer Nipro Medical Corp. has voluntarily recalled its Exel/Exelint Huber needles manufactured between January 2007 and August 2009."   Doctors, nurses, and patients should not be using these needles under any circumstances.

Bloomberg News (1/27, Peterson) reports that the "defect...might lead to fatal blockages of the main artery of the lung, the [FDA] said." The needles, which are intended "to give food and medicine to chronically ill patients," can "dislodge 'cores,' or slivers of silicon, from 'ports' under the skin and release the material into the bloodstream, FDA officials said." Jon Casamento, deputy director of the Solid and Fluid Mechanics Division at the FDA's Center for Devices and Radiological Health, said the "defective needles...may cause tissue damage and inadequate drug delivery."

Regulators have not received reports that the needles released silicon or other foreign chemicals into patients, but the defect is difficult for doctors to detect, Dow Jones Newswire (1/27, Favole) reports.

CNN (1/27, Young) reports that the FDA "said anyone using the products should stop immediately and return any unused needles to Exelint." The agency indicated that it is conducting investigations "of needles from 20 companies," of which 10 have already been completed. "The FDA said it has sent letters to all Huber manufacturers asking them to address any design or manufacturing problems."

About the author:

Mr. Zambri is a Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. and has been rated by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all lawyers in the Washington metropolitan area.  The magazine also describes him as "one of Washington's best--most honest and effective lawyers" who specializes in personal injury matters, including product liability, medical malpractice, and automobile accident claims.  Mr. Zambri has also been named a "Super Lawyer" by Super Lawyer magazine (March/April 2009)--a national publication that honors the top lawyers in America.  

Mr. Zambri was sought after to publish a chapter regarding product liability litigation in Aspatore Books - a company that is touted as "the largest and most exclusive publisher of C-1 Level executives (CEO, CFO, CTO, CMO, Partner) from the world's most respected companies and law firms."  To read Mr. Zambri's publication, entitled "Constantly Preparing To Win", please click here.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.  

Posted In Medical Malpractice , Medications , Men's Health Issues , Nursing Home Negligence , Obstetrics , Patient Safety , Pediatrics , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Trailblazer Support Catheter Recalled, Dangerous

 Posted by: Salvatore J. Zambri, founding partner     

ev3 Endovascular, Inc. and FDA notified healthcare professionals of a Class I Recall of the Trailblazer Support Catheter. According to the recall, "This device may crack near the radiopaque marker band. This may result in serious patient injury, including insufficient oxygen supply to the tissues, damage to blood vessels, heart attack, limb amputation, unplanned surgery, and/or death."

If using a catheter, please contact your doctor immediately to be sure it is not part of the recall.  If you know you are using a Trailblazer Support Catheter, please stop using it right away, and obtain an alternative product.

About the author:

Mr. Zambri is a Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. and has been rated by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all lawyers in the Washington metropolitan area.  The magazine also describes him as "one of Washington's best--most honest and effective lawyers" who specializes in personal injury matters, including product liability, medical malpractice, and automobile accident claims.  Mr. Zambri has also been named a "Super Lawyer" by Super Lawyer magazine (March/April 2009)--a national publication that honors the top lawyers in America.  

Mr. Zambri was sought after to publish a chapter regarding product liability litigation in Aspatore Books - a company that is touted as "the largest and most exclusive publisher of C-1 Level executives (CEO, CFO, CTO, CMO, Partner) from the world's most respected companies and law firms."  To read Mr. Zambri's publication, entitled "Constantly Preparing To Win", please click here.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.   

Posted In Medical Malpractice , Men's Health Issues , Nursing Home Negligence , Obstetrics , Patient Safety , Pediatrics , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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FDA WARNING: NZU, A MORNING SICKENESS "REMEDY" MAY CONTAIN HIGH LEVELS OF LEAD/ARSENIC

Posted by Catherine D. Bertram                                                        

On December 31, 2009, the FDA issued a warning to consumers and medical professionals, "especially pregnant or breastfeeding women, to avoid consuming a product called “Nzu”, taken as a traditional remedy for morning sickness,because of the potential health risks from high levels of lead and arsenic, noted on laboratory analysis by Texas DSHS. Exposure to lead can result in a number of harmful effects, and a developing child is particularly at risk of effects on the brain and nervous system. Arsenic is a carcinogen, and excessive long-term exposure to it has been associated with a range of adverse health effects, including cancers of the urinary bladder, lung and skin. Nzu, which is sold at African specialty stores is also called Calabash clay, Calabar stone, Mabele, Argile and La Craie. It generally resembles balls of clay or mud and is usually sold in small plastic bags with a handwritten label identifying it as “Nzu” or “Salted Nzu.” Anyone who has been ingesting the product should contact their health care provider."

Any adverse events that may be related to use should be reported to the FDA's MedWatch Safety Information and Adverse Event Reporting Program online by clicking here or by phone at 1-800-332-1088.

 If you have any questions about injuries related to this medication, or any other medication, you can call our firm for more information about your legal rights.  Click here to contact us online or call us at 202-463-3030.

About the author:

Catherine Bertram is board certified in civil trials and was recently nominated as a 2010 Super Lawyer for Washington, D.C.  Ms. Bertram has 20 years of trial experience and is unique in that she was formerly the Director of Risk Management for Georgetown University Hospital so she brings a wealth of knowledge to her practice including how hospitals should be run and what doctors and nurses can do to protect patients.   She is a partner with the firm and devotes her practice to the representation of patients and families of loved ones who have been injured or lost due to medical errors.  Ms. Bertram lectures regularly to lawyers and health care providers, nationally and locally,  regarding patient safety, medical negligence and other related issues. She has also recently published a chapter in a medical textbook.   She can be reached by email at cbertram@reganfirm.com or by phone 202-822-1875 in her office in Washington, D.C.

 

 

Posted In Medical Malpractice , Medications , Patient Safety , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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FDA Issues Warning For Hypertension Drug

 Posted by: Salvatore J. Zambri, founding partner     


The AP reports that officials with the Food and Drug Administration warned doctors recently that "about 11 recalled lots of an intravenous hypertension drug made by the Medicines Co. are contaminated with bits of steel." According to the agency, the particles "could potentially disrupt blood flow to the brain, kidney, liver heart and lungs." Medicines Co. recalled the affected lots of Cleviprex (clevidipine butyrate).

If you believe you have been prescribed this drug, contact your doctor immediately.

About the author:

Mr. Zambri is a Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. and has been rated by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all lawyers in the Washington metropolitan area.  The magazine also describes him as "one of Washington's best--most honest and effective lawyers" who specializes in personal injury matters, including product liability, medical malpractice, and automobile accident claims.  Mr. Zambri has also been named a "Super Lawyer" by Super Lawyer magazine (March/April 2009)--a national publication that honors the top lawyers in America.  

Mr. Zambri was sought after to publish a chapter regarding product liability litigation in Aspatore Books - a company that is touted as "the largest and most exclusive publisher of C-1 Level executives (CEO, CFO, CTO, CMO, Partner) from the world's most respected companies and law firms."  To read Mr. Zambri's publication, entitled "Constantly Preparing To Win", please click here.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.   

Posted In Medical Malpractice , Medications , Men's Health Issues , Patient Safety , Pediatrics , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Pfizer Wants Prempro Internet Video Removed

 Posted by: Salvatore J. Zambri, founding partner     


Bloomberg News (12/16, O'Reilly, Feeley) reports, "Pfizer Inc. asked a judge to order the removal of an Internet video about its menopause medicines that the company says is misleading and aimed at swaying potential jurors in future trials over the pills." The video, called "Prempro News Segment," was posted on YouTube.com by "plaintiffs' lawyers who recently won more than $78 million in damages in a Pennsylvania trial over Pfizer's Prempro hormone-replacement drug."

At issue in that case was whether the "menopause drugs helped cause" the plaintiff's breast cancer. In the video, "breast-cancer victims discuss their cases," while the attorneys "accuse Wyeth of minimizing the risks of Prempro." According to Pfizer's lawyers, "Pennsylvania rules governing lawyer ethics prohibit lawyers from making pre-trial statements to the press that could 'prejudice' an upcoming case."

About the author:

Mr. Zambri is a Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. and has been rated by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all lawyers in the Washington metropolitan area.  The magazine also describes him as "one of Washington's best--most honest and effective lawyers" who specializes in personal injury matters, including product liability, medical malpractice, and automobile accident claims.  Mr. Zambri has also been named a "Super Lawyer" by Super Lawyer magazine (March/April 2009)--a national publication that honors the top lawyers in America.  

Mr. Zambri was sought after to publish a chapter regarding product liability litigation in Aspatore Books - a company that is touted as "the largest and most exclusive publisher of C-1 Level executives (CEO, CFO, CTO, CMO, Partner) from the world's most respected companies and law firms."  To read Mr. Zambri's publication, entitled "Constantly Preparing To Win", please click here.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.   
 

Posted In Medical Malpractice , Medications , Men's Health Issues , Nursing Home Negligence , Patient Safety , Pediatrics , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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800,000 Swine Flu Vaccine Doses Recalled

 

 Posted by: Salvatore J. Zambri, founding partner     


A massive recall of swine flu vaccine doses drew national attention recently when it was announced by the Center for Disease Control.  ABC World News (12/15, story 6, 0:20, Gibson) reports that federal health officials "are recalling 800,000 children doses of swine flu vaccine...made by Sanofi Pasteur." NBC Nightly News (12/15, story 2, 0:35, Williams) reported that the doses "are less potent than they should have been."

The Los Angeles Times (12/16, Maugh) reports that Centers for Disease Control and Prevention director Dr. Anne Schuchat said the recall was "non-safety-related," and was "part of a routine quality assurance program." Schuchat emphasized that "children who received the vaccine do not need to be re-immunized," but the agency "wanted to make sure that doses that weren't already given won't be." The Washington Post (12/16, Stein, Laris) reports that "most of the vaccine, which was distributed nationwide in November, has probably already been used."

Bloomberg News (12/16, Randall) reports that Sanofi "began delivering swine flu vaccine in the US in September, with the bulk of deliveries expected in the fourth quarter." The United States "has ordered 75 million doses from the Paris- based company." CQ HealthBeat (12/16, Norman) reports that the problem was identified during "ongoing quality assessments" made by the drugmaker. The New York Times (12/16, A28, Mcneil) reports that Dr. Schuchat "said the vaccine was fully potent at release but dropped by about 12 percent in follow-up tests." In a story appearing in some form on over 320 news websites, the AP (12/16, Stobbe) reports that Jesse Goodman, the FDA's deputy commissioner for science and public health, said the problem may be related to the antigen sticking to the walls of children's pre-filled syringes.

USA Today (12/16, Sternberg) reports that the affected vaccine, "packaged in half-dose amounts meant for children 6 months to nearly 3 years old, represents about 1% of the nation's H1N1 vaccine supply." Sanofi spokesman Len Lavenda said the doses comprise roughly "18% of the 4.5 million doses in prefilled syringes made by Sanofi for children in that age group." Lavenda commented that officials were "baffled" by the weakened vaccine, adding "we can't remember a time when flu vaccine lost potency." The Wall Street Journal (12/16, Dooren) reports that Sanofi will be notifying providers to return any unused doses.

Reuters (12/16, Fox) also reported on this story, while Time (12/16, O'Callaghan) mentioned the recall in their "Wellness" blog.

Please be careful when taking a vaccine or allowing a loved one to be injected.  We urge you to speak with your doctor about all pros and cons of any drug before ingesting it.

About the author:

Mr. Zambri is a Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. and has been rated by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all lawyers in the Washington metropolitan area.  The magazine also describes him as "one of Washington's best--most honest and effective lawyers" who specializes in personal injury matters, including product liability, medical malpractice, and automobile accident claims.  Mr. Zambri has also been named a "Super Lawyer" by Super Lawyer magazine (March/April 2009)--a national publication that honors the top lawyers in America.  

Mr. Zambri was sought after to publish a chapter regarding product liability litigation in Aspatore Books - a company that is touted as "the largest and most exclusive publisher of C-1 Level executives (CEO, CFO, CTO, CMO, Partner) from the world's most respected companies and law firms."  To read Mr. Zambri's publication, entitled "Constantly Preparing To Win", please click here.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.   

Posted In Medical Malpractice , Medications , Men's Health Issues , Nursing Home Negligence , Obstetrics , Patient Safety , Pediatrics , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Glaxo Announces Payouts From Paxil Cases

 Posted by: Salvatore J. Zambri, founding partner     

Bloomberg.com reports that GlaxoSmithKline "has settled 450 suicide cases for about $390 million and 600 birth defect cases for unspecified amounts." According to the report, "The company has also paid out about $400 million in antitrust cases since 2003."

Many people who have taken Paxil have been subjected to an increased risk for suicide and birth defects.  The extent of the increased risk has never been disclosed. 

I represent victims of dangerous products.  Far too often companies put profits over people, placing into the marketplace drugs that have not been properly tested.  We hope that companies will put people over profits and be sure their products are safe before they are sold.

Before taking any medication, be sure to consult with a physician.  Your physician should also inform you of all risks and benefits of a medication before you ingest it, so that you can make the best health decisions you can.

About the author:

Mr. Zambri is a Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. and has been rated by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all lawyers in the Washington metropolitan area.  The magazine also describes him as "one of Washington's best--most honest and effective lawyers" who specializes in personal injury matters, including product liability, medical malpractice, and automobile accident claims.  Mr. Zambri has also been named a "Super Lawyer" by Super Lawyer magazine (March/April 2009)--a national publication that honors the top lawyers in America.  

Mr. Zambri was sought after to publish a chapter regarding product liability litigation in Aspatore Books - a company that is touted as "the largest and most exclusive publisher of C-1 Level executives (CEO, CFO, CTO, CMO, Partner) from the world's most respected companies and law firms."  To read Mr. Zambri's publication, entitled "Constantly Preparing To Win", please click here.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.    

Posted In Cancer Misdiagnosis , Cerebral Palsy , Medical Malpractice , Medications , Men's Health Issues , Nursing Home Negligence , Patient Safety , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Cartons of Berries & Balsamic Salad Recalled

 Posted by: Salvatore J. Zambri, founding partner     

The FDA has announced that a California-based company--organicgirl produce--has recalled 120 cartons of its 5.75 oz Berries & Balsamic Salad "because it may contain an incorrect condiment packet with an unlabeled allergen for walnuts."

"The product is packaged in plastic trays in a 6-count carton, UPC 895203-001332, product lot number 31B073830, with Use-By Date of December 16, 2009."  If you have an allergy to walnuts, do not eat this product.  Doing so would "run the risk of serious or life-threatening allergic reaction," says the FDA.

If you purchased the recalled product, you are urged to return it to the place you bought it from for a full refund. If you have any questions, you may also contact organicgirl produce at 1-831-758-7810.

It is common for people to have allergic reactions to all kinds of foods.  That is why it is critically important for all food suppliers to carefully label what the product contains.  Without appropriate warnings, public health is compromised. 

Many people die every year as a result of food allergies.  If you have an allergy to a food product, read labels carefully.  If eating at a restaurant, ask your server to confirm the absence of the product you are allergic to when ordering.

Enjoy your meals, but please be careful to ingest only what you know is safe.

About the author:

Mr. Zambri is Past-President of the Trial Lawyers Association of Metropolitan Washington, DC and has been rated by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all lawyers in the Washington metropolitan area.  The magazine also describes him as "one of Washington's best--most honest and effective lawyers" who specializes in personal injury matters, including medical malpractice actions stemming from defective or dangerous medications.   He has also been named a "DC Super Lawyer" by Super Lawyer magazine (March/April 2009)--a national publication that honors the top lawyers in America.  If you need a patient advocate, we recommend that you read an article about medical malpractice claims authored by senior partner Salvatore Zambri.

Mr. Zambri is regularly asked to present seminars to lawyers and business professionals concerning product defects, product liability litigation, and safety improvements.

Mr. Zambri was sought after to publish a chapter regarding product liability litigation in Aspatore Books - a company that is touted as "the largest and most exclusive publisher of C-1 Level executives (CEO, CFO, CTO, CMO, Partner) from the world's most respected companies and law firms."  To read Mr. Zambri's publication, entitled "Constantly Preparing To Win", please click here.

If you want more information about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.  

 

Posted In Medical Malpractice , Medications , Men's Health Issues , Patient Safety , Pediatrics , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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State Tort "Reforms" Don't Lower Insurance Premiums

 Posted by: Salvatore J. Zambri, founding partner     

The American Association for Justice has published an article that establishes what we have known now for some time--that state tort "reforms" have provided a boon to insurance companies, while physician and patient premiums continue to skyrocket.  The winner:  insurnace companies, whose profits have hit record levels.  The losers:  doctors and, especially, patients, whose fundamental rights have been taken from them.

"An analysis of data from the National Association of Insurance Commissioners (NAIC) and company annual statements shows malpractice insurer profits are 24 percent higher in states with caps.  In these cap states, insurers took in 3.5 times more in premiums than they paid out in 2008.  In contrast, insurers in states without caps took in just over twice what they paid in claims."

98,000 people die every year from preventable medical errors, yet the insurnace industry and the chamber of commerce want o place nonsensical limits on patients' rights simply to pad insurance companies' profits.  This profits-over-people model is anti-American and unethical.

The report establishes that the "medical malpractice insurance industry has seen a 47 percent increase in profitability in the last 10 years. Overblown 'reported' losses were used by the insurance industry to justify new measures restricting the rights of those injured by medical negligence."

Americans need to fight back against the myths spread by special interest group.  Over 30 states have been fooled into thinking caps on daages will help pemiums.  They haven't. In the meantime, though, "the average profit of the 10 largest medical malpractice insurers was higher than 99 percent of Fortune 500 companies and 35 times higher than the Fortune 500 average."

To view a copy of Insurance Company Handout: How the Industry Used Tort Reform to Increase Profits While Americans' Premiums Soared, visit http://www.justice.org/clips/Insurance_Company_Handout.pdf.

As I mentioned, It is widely accepted that approximately 98,000 Americans die every year as a result of medical errors.  That's like two 747 airplanes full of passengers crashing to the ground every day for a year.  Yet, some legislators want to strip innocent victims of their constitutional rights, including limiting their recoveries, instead of focusing on preventing future errors. 

Our leaders should be fighting for safer drugs, safer hospitals, better medical practices, and a safer American health system.  We must put people over profits.

About the author:

Mr. Zambri is Past-President of the Trial Lawyers Association of Metropolitan Washington, DC and has been rated by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all lawyers in the Washington metropolitan area.  The magazine also describes him as "one of Washington's best--most honest and effective lawyers" whose practice is dedicated to handling catastrophic personal injury matters, including medical malpractice actions stemming from defective or dangerous medications and medical errors.   He has also been named a "DC Super Lawyer" by Super Lawyer magazine (March/April 2009)--a national publication that honors the top lawyers in America.  If you need a patient advocate, we recommend that you read an article about medical malpractice claims authored by senior partner Salvatore Zambri.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you want more information about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899. 

 

 

Posted In Cancer Misdiagnosis , Cerebral Palsy , Medical Malpractice , Medications , Men's Health Issues , Nursing Home Negligence , Obstetrics , Patient Safety , Pediatrics , Product Liability , Public Health , Tort Reform , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Medical Malpractice Accounts for Far less than 1% of Overall Healthcare Costs

 

 Posted by: Salvatore J. Zambri, founding partner     

According to a study from Public Citizen,  medical malpractice payments to patients who have been injured due to medical errors declined for the third year in a row.  The study further shows that the payouts total between merely 0.18% and 0.6% of the overall medical costs in this country. 

Is this decline the result of better medical care?  Unfortunately, no, according to the study.   Instead, fewer injured patients are being compensated.  Approximately 98,000 people are killed every year in this country due to medical mistakes, but payouts only go to about 11,000 of them.  If there is a medical malpractice crisis in this country, the core of the crisis is sloppy medicine, not frivolous lawsuits, notes the study:

More than 80 percent of the money paid out for medical malpractice in 2008 was for cases involving "significant permanent injuries"; "major permanent injuries"; injuries resulting in quadriplegia, brain damage or the need for permanent care; or death, according to NPDB [National Practitioner Data Bank] reporting.

Despite the hysteria surrounding debates over medical malpractice litigation, experts have repeatedly concluded that several times as many patients suffer avoidable injuries as those who sue. The best known such finding was included in the Institute of Medicine’s (IOM) seminal 1999 study, "To Err Is Human," which concluded that between 44,000 and 98,000 Americans die every year because of avoidable medical errors. Fewer than 15,000 people (including those with non-fatal outcomes) received compensation for medical malpractice that year, and in 2008, the number receiving compensation fell to just over 11,000.

Patient safety needs to become a priority in this country.  Unless it does, thousands upon thousands of Americans will be needlessly killed or seriously injured each year. 

About the author:

Mr. Zambri is Past-President of the Trial Lawyers Association of Metropolitan Washington, DC and has been rated by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all lawyers in the Washington metropolitan area.  The magazine also describes him as "one of Washington's best--most honest and effective lawyers" whose practice is dedicated to handling catastrophic personal injury matters, including medical malpractice actions stemming from defective or dangerous medications and medical errors.   He has also been named a "DC Super Lawyer" by Super Lawyer magazine (2009-2010)--a national publication that honors the top lawyers in America. 

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you want more information about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899. 

Posted In Cancer Misdiagnosis , Medical Malpractice , Medications , Men's Health Issues , Nursing Home Negligence , Obstetrics , Patient Safety , Pediatrics , Product Liability , Public Health , Tort Reform , U.S. Food and Drug Administration Warnings , Women's Health Issues
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WARNING LABELS FOR ANTIPSYCHOTICS MAY BE STRENGTHENED

 Posted by: Salvatore J. Zambri, founding partner     

Dow Jones Newswires (12/8, Dooren) reported that Thomas Laughren, the director of FDA's division of psychiatric products, said Tuesday that the agency is weighing tougher warning labels for antipsychotics that might cause weight gain and diabetes.  According to the report, "the agency has asked manufacturers of drugs like Seroquel, Abilify and Zyprexa for all of the information they have on metabolic side effects such as increases in blood glucose" to determine whether warnings need to be improved.  This comes in the wake of concerns of how antipsychotic medication has been effecting children in particular.

Like all drugs, antipsychotic medication should never be taken without a doctor's prescription, and a physician should never prescribe this medication unless it is in the best interest of the patient and only after the patient has been fully informed of all of the risks and benefits of the drug. 

About the author:

Mr. Zambri is Past-President of the Trial Lawyers Association of Metropolitan Washington, DC and has been rated by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all lawyers in the Washington metropolitan area.  The magazine also describes him as "one of Washington's best--most honest and effective lawyers" whose practice is dedicated to handling catastrophic personal injury matters, including medical malpractice actions stemming from defective or dangerous medications and medical errors.   He has also been named a "DC Super Lawyer" by Super Lawyer magazine (March/April 2009)--a national publication that honors the top lawyers in America. 

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you want more information about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899. 

Posted In Medical Malpractice , Medications , Men's Health Issues , Patient Safety , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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FDA UPDATE: EXCESS RADIATION TO PATIENTS FROM CT SCANNERS

By Catherine D. Bertram, Partner                                             

The FDA issued an update about the safety investigation they are conducting regarding CT perfusion scanners and patients' overexposure to radiation. The FDA's initial notice was issued October 8, 2009.

Earlier  there were reports of patients who were accidentally exposed to eight times the normal radiation dose during diagnostic CT scans at Cedars-Sinai Medical Center in Los Angeles are prompting safety warnings to be issued across the country.

According to the FDA, over an 18-month period, 206 patients at the center received 3 to 4 Gy to the head instead of the expected 0.5-Gy dose during perfusion CT imaging.

"Until we get through whether we're dealing with errors that people are making (or) whether these are problems with the CT scanners themselves, we're saying go back to basics," said Jeffrey Shuren, MD, acting director of the FDA's Center for Devices and Radiological Health.

The FDA released a set of recommendations which include:

  • Imaging facilities should review their radiation dosing protocols for all CT perfusion studies to ensure that dosing is correct for each study.
  • They should implement quality control procedures to ensure that protocols are followed and correct radiation is used.
  • For each patient, technologists should check the CT scanner displays to make sure the radiation to be delivered is appropriate.
  • If more than one study is performed during one session, practitioners should adjust the radiation dose so it is appropriate for each study.

The FDA also urged imaging facilities to check whether any patients who underwent CT perfusion scans have received excess radiation.

"We're reminding (practitioners) of good practices that they should be employing routinely," said FDA representative Charles Finder, MD.

Tragically, I have specific experience with several cases involving excessive exposure to radiation. Patients can suffer extremely serious and irreversible injuries.   Of course, these are patients who are already fighting challenging medical conditions, including cancer.   We have top notch national experts in radiation oncology who review these cases to determine if the care provided was unsafe and caused the patient harm.  These cases can be a result of an  unsafe medical device or can be caused by the improper conduct of the health care team, or both.

 

 

Continue Reading Posted In Patient Safety , Public Health , U.S. Food and Drug Administration Warnings
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American Associate for Justice Publishes Primer on Medical Negligence Debate: A Must Read

 

 Posted by: Salvatore J. Zambri, founding partner     

The American Association for Justice has published a primer on the medical malpractice debate.  It comprehensively shows how special interest groups have perpetuated myths in an effort to strip Americans of their rights in order to pad their profits.  Here are some of the findings:

  • Myth #1: There are too many “frivolous” malpractice lawsuits
  • Myth #2: Malpractice claims drive up health care costs.
  • Myth #3: Doctors are fleeing.
  • Myth #4: Malpractice claims drive up doctors’ premiums.
  • Myth #5: Tort reform will lower insurance rates.

It is widely accepted that approximately 98,000 Americans die every year as a result of medical errors.  That's like two 747 airplanes full of passengers crashing to the ground every day for a year.  Yet, some legislators want to strip innocent victims of their constitutional rights, including limiting their recoveries, instead of focusing on preventing future errors. 

Our leaders should be fighting for safer drugs, safer hospitals, better medical practices, and a safer American health system.  We must put people over profits.

To read the publication, please click here.

About the author:

Mr. Zambri is Past-President of the Trial Lawyers Association of Metropolitan Washington, DC and has been rated by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all lawyers in the Washington metropolitan area.  The magazine also describes him as "one of Washington's best--most honest and effective lawyers" whose practice is dedicated to handling catastrophic personal injury matters, including medical malpractice actions stemming from defective or dangerous medications and medical errors.   He has also been named a "DC Super Lawyer" by Super Lawyer magazine (March/April 2009)--a national publication that honors the top lawyers in America.  If you need a patient advocate, we recommend that you read an article about medical malpractice claims authored by senior partner Salvatore Zambri.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you want more information about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899. 

Posted In Cancer Misdiagnosis , Medical Malpractice , Medications , Men's Health Issues , Nursing Home Negligence , Obstetrics , Patient Safety , Pediatrics , Product Liability , Public Health , Tort Reform , U.S. Food and Drug Administration Warnings , Women's Health Issues
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GAO Says FDA Lacking in Developing Drug Surveillance Office

 

 Posted by: Salvatore J. Zambri, founding partner     

 

The Associated Press has reported today that the Food and Drug Administration (FDA) "still hasn't restructured its staff to better monitor drug safety, more than three years after experts recommended key changes in the wake of the Vioxx scandal."  According to the report, the Government Accountability Office (GAO) will release a report today indicating that FDA officials "have made some changes to drug oversight," although the agency "continues to give the bulk of its decision-making power to scientists who approve new drugs, rather than those who monitor the side effects of drugs on the market."  Consequently, the GAO "calls on the FDA to set a timetable for transferring new responsibilities to the surveillance office."

In response, the FDA "said major decisions about drug safety are delegated to the new drugs division because that is 'where staff with the broadest expertise and experience' on product safety issues reside," according to the AP report.

We urge the FDA to ramp up its surveillance of drugs, and we implore pharmaceutical companies to be sure their products are safe before placing them into the marketplace.  Drugs are obviously important, but manufacturers need to put people over profits.  No drug should enter the marketplace until it has been thoroughly tested and until its side-effects are fully understood.

Before taking any medication, please confer with your doctor.  Know all risks and benefits of a drug before taking it.

We wish you good health.

About the author:

Mr. Zambri is Past-President of the Trial Lawyers Association of Metropolitan Washington, DC and has been rated by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all lawyers in the Washington metropolitan area.  The magazine also describes him as "one of Washington's best--most honest and effective lawyers" who dedicates his practice to catastrophic personal injury matters, including medical malpractice actions stemming from defective or dangerous medications.   He has also been named a "DC Super Lawyer" by Super Lawyer magazine (March/April 2009)--a national publication that honors the top lawyers in America.  If you need a patient advocate, we recommend that you read an article about medical malpractice claims authored by senior partner Salvatore Zambri.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you want more information about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899. 

Posted In Cancer Misdiagnosis , Cerebral Palsy , Medical Malpractice , Medications , Men's Health Issues , Patient Safety , Pediatrics , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Alka-Seltzer Cold Capsules Recalled

 Posted by: Salvatore J. Zambri, founding partner     

 

The Los Angeles Times reports that "Bayer Healthcare is recalling 100,000 packages of Alka-Seltzer cold capsules because some do not properly display warning information about drowsiness."  The recalls pertains to packages of Alka-Seltzer Plus Day & Night Liquid Gels, according to the report.

"Company spokeswoman Tricia McKernan said the problem was caused by human error during the printing process. McKernan said the machinery used to make the labeling had to be shut down and manually restarted during the production for the affected lot."

If you have purchased these medications from lot 296939L--a lot that was distributed nationwide--please stop using the product and contact Bayer .  The manufacturer's phone number is (800) 986-3307, and they will provide a refund.

Be sure never to operate heavy machinery, drive a car, or engage in any dangerous activity while taking medication that has the potential to make you drowsy.

About the author:

Mr. Zambri is Past-President of the Trial Lawyers Association of Metropolitan Washington, DC and has been rated by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all lawyers in the Washington metropolitan area.  The magazine also describes him as "one of Washington's best--most honest and effective lawyers" who specializes in personal injury matters, including medical malpractice actions stemming from defective or dangerous medications.   He has also been named a "DC Super Lawyer" by Super Lawyer magazine (March/April 2009)--a national publication that honors the top lawyers in America.  If you need a patient advocate, we recommend that you read an article about medical malpractice claims authored by senior partner Salvatore Zambri.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you want more information about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.  

Posted In Medical Malpractice , Medications , Men's Health Issues , Patient Safety , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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New Paper Debunks Medical Malpractice Myths


 Posted by: Salvatore J. Zambri, founding partner     

The American Association for Justice has published a paper that concisely and clearly debunked the myths about medical malpractice which has been spread by business interest groups aimed at putting profits over people.  In the first of a series of papers, Public Citizen debunks the following "five myths: 

  • Myth #1: There are too many “frivolous” malpractice lawsuits.

Fact: There’s an epidemic of medical negligence, not lawsuits.  Only one in eight people injured by medical negligence ever file suit.  Civil filings have declined eight percent over the last decade, and are less than one percent of the whole civil docket.  A 2006 Harvard study found that 97 percent of claims were meritorious, stating, “portraits of a malpractice system that is stricken with frivolous litigation are overblown.”

  • Myth #2: Malpractice claims drive up health care costs.

Fact: According to the National Association of Insurance Commissioners, the total spent defending claims and compensating victims of medical negligence was just 0.3% of health care costs, and the Congressional Budget Office and Government Accountability Office have made similar findings.

  • Myth #3: Doctors are fleeing.

Fact: Then where are they going?  According to the American Medical Association’s own data, the number of practicing physicians in the United States has been growing steadily for decades. Not only are there more doctors, but the number of doctors is increasing faster than population growth.  Despite the cries of physicians fleeing multiple states, the number of physicians increased in every state, and only four states saw growth slower than population growth; these four states all have medical malpractice caps.

  • Myth #4: Malpractice claims drive up doctors’ premiums.

Fact: Empirical research has found that there is little correlation between malpractice payouts and malpractice premiums paid by doctors. A study of the leading medical malpractice insurance companies’ financial statements by former Missouri Insurance Commissioner Jay Angoff found that these insurers artificially raised doctors’ premiums and misled the public about the nature of medical negligence claims.  A previous AAJ report on malpractice insurers found they had earnings higher than 99% of Fortune 500 companies.

  • Myth #5: Tort reform will lower insurance rates.

Fact:  Tort reforms are passed under the guise that they will lower physicians’ liability premiums. This does not happen. While insurers do pay out less money when damages awards are capped, they do not pass the savings along to doctors by lowering premiums. Even the most ardent tort reformers have been caught stating that tort reform will have no effect on insurance rates."

It is widely accepted that approximately 98,000 Americans die every year as a result of medical errors.  That's like two 747 airplanes full of passengers crashing to the ground every day for a year.  Yet, some legislators want to strip innocent victims of their constitutional rights, including limitibg their recoveries, instead of focusing on preventing future errors. 

Don't let your legislative representatives takes your rights away just so some special interest groups can pad their profits.  Fight for safer hospitals, better medical practices, and a safer American health system.  We must put people over profits.

About the author:

Mr. Zambri is Past-President of the Trial Lawyers Association of Metropolitan Washington, DC and has been rated by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all lawyers in the Washington metropolitan area.  The magazine also describes him as "one of Washington's best--most honest and effective lawyers" who specializes in personal injury matters, including medical malpractice actions stemming from defective or dangerous medications and medical errors.   He has also been named a "DC Super Lawyer" by Super Lawyer magazine (March/April 2009)--a national publication that honors the top lawyers in America.  If you need a patient advocate, we recommend that you read an article about medical malpractice claims authored by senior partner Salvatore Zambri.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you want more information about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899. 

Posted In Medical Malpractice , Medications , Men's Health Issues , Nursing Home Negligence , Obstetrics , Patient Safety , Pediatrics , Product Liability , Public Health , Tort Reform , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Reputable Consumer Group Petitions For Ban of Drug Meridia

 Posted by: Salvatore J. Zambri, founding senior partner     

 

The AP recently reported,  "A consumer advocacy group is petitioning the government to ban the weight loss pill Meridia [sibutramine] because a recent study suggests it increases the risk of heart attack, stroke, and death." In a letter to the Food and Drug Administration (FDA), the consumer watch-dog--Public Citizen--calls on the agency "to pull Abbott Laboratories' drug from the US market," citing results from "a 10,000-patient study" that "showed a slightly higher risk of heart-related problems in patients taking Meridia...compared with a dummy pill."

The FDA, however, "said it was 'making no conclusions about the preliminary findings' when they were released last month." The agency "previously rejected a 2002 petition from Public Citizen to withdraw Meridia," saying "it wanted to wait for the findings of the 10,000-patient study."

We will soon see how the FDA responds to the study. In the meantime, please be very careful when taking any medication.  You should always get competent, expert medical advice for ingesting any medication.  Be sure, too, that your doctor fully explains all risks associated with certain medications so that you can make a wise decision about what's best for you and your body.
      

About the author:

Mr. Zambri is Past-President of the Trial Lawyers Association of Metropolitan Washington, DC and has been rated by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all lawyers in the Washington metropolitan area.  The magazine also describes him as "one of Washington's best--most honest and effective lawyers" who specializes in personal injury matters, including medical malpractice actions stemming from defective or dangerous medications.   He has also been named a "DC Super Lawyer" by Super Lawyer magazine (March/April 2009)--a national publication that honors the top lawyers in America.  If you need a patient advocate, we recommend that you read an article about medical malpractice claims authored by senior partner Salvatore Zambri.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you want more information about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899. 

Posted In Medical Malpractice , Medications , Men's Health Issues , Patient Safety , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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FDA Warning: Excessive Radiation from CT Brain Perfusion Scans

By Catherine D. Bertram, Esquire                                

The U.S. Food and Drug Administration, FDA, issued an updated warning to health care professionals today regarding excessive radiation exposure for an additional 50 patients during CT brain perfusion scans.  The warning is as follows:

"The FDA, working with state and local health authorities, has identified at least 50 additional patients who were exposed to excess radiation of up to eight times the expected level during their CT perfusion scans. These cases so far involve more than one manufacturer of CT scanners. Some of these patients reported hair loss or skin redness following their scans. High doses of radiation can cause cataracts and increase the risk of some forms of cancer.
On the basis of its investigation to date, the FDA is providing interim recommendations for imaging facilities, radiologists, and radiologic technologists to help prevent additional cases of excess exposure.

These recommendations include:
•    Facilities assess whether patients who underwent CT perfusion scans received excess radiation.
•    Facilities review their radiation dosing protocols for all CT perfusion studies to ensure that the correct dosing is planned for each study.
•    Facilities implement quality control procedures to ensure that dosing protocols are followed every time and the planned amount of radiation is administered.
•    Radiologic technologists check the CT scanner display panel before performing a study to make sure the amount of radiation to be delivered is at the appropriate level for the individual patient.
•    If more than one study is performed on a patient during one imaging session, practitioners should adjust the dose of radiation so it is appropriate for each study."


You can review the MedWatch safety summary, including a link tlo the FDA News Release, by clicking here.

About the author:

Catherine Bertram is board certified in civil trials.  Ms. Bertram has 20 years of trial experience and is unique in that she was formerly the Director of Risk Management for Georgetown University Hospital so she brings a wealth of knowledge to her practice including how hospitals should be run and what doctors and nurses can do to protect patients.   She is a partner with the firm and devotes her practice to the representation of patients and families of loved ones who have been injured or lost due to medical errors.  Ms. Bertram lectures regularly to lawyers and health care providers, nationally and locally,  regarding patient safety, medical negligence and other related issues. She can be reached by email at cbertram@reganfirm.com or by phone 202-822-1875. 

 

 


 

Posted In Patient Safety , Product Liability , U.S. Food and Drug Administration Warnings
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Task Force Study Regarding Effectiveness of Mammograms Sparks Political Debate

Posted by: Salvatore J. Zambri, Esquire

A recent federal task force's study that discourages routine mammograms for most women below the age of 50 has sparked a major political debate.  As a Washington Post article puts it, "The findings underscore a decades-long debate in the medical community about the benefits and risks of routine breast cancer screening for younger women."

In response to the study, Rep. Frank Pallone Jr. (D-N.J.) "announced that his House health subcommittee will hold hearings on the mammogram issue next month," according to the Post report.  And legislators from both political parties are suggesting that "the task force had been swayed by insurance companies that stand to save money if fewer screenings are performed."

Certainly, insurance companies' greed should not dictate what treatments are best for patients.  Those decisions should be left to medical experts who know what they are talking about, who are responsible for making sound decisions and informing their patients of all attendant risks and benefits.  As it stands, the  American Cancer Society has reiterated that it will continue to recommend regular mammograms for women age 40 and above. 

About the author:

Mr. Zambri is Past-President of the Trial Lawyers Association of Metropolitan Washington, DC and has been rated by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all lawyers in the Washington metropolitan area.  The magazine also describes him as "one of Washington's best--most honest and effective lawyers" who specializes in personal injury matters, including medical malpractice actions stemming from misdiagnosed cancer and dangerous drugs.  He has also been named a "DC Super Lawyer" by Super Lawyer magazine (March/April 2009)--a national publication that honors the top lawyers in America.  If you need a patient advocate, we recommend that you read an article about medical malpractice claims authored by senior partner Salvatore Zambri.

If you want more information about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.

Posted In Cancer Misdiagnosis , Medical Malpractice , Medications , Men's Health Issues , Patient Safety , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Federal Task Force Challenges Uefulness of Mammograms, Sparks Intense Debate

Posted by: Salvatore J. Zambri, Esquire

As reported in the Washington Post, a federal task force has concluded, "Women in their 40s should stop routinely getting annual mammograms, and older women should cut back to one scheduled exam every other year." 

The report notes that higher than "182,000 women are diagnosed with breast cancer each year in the United States, and the disease kills more than 40,000, making it the second most common cancer after skin cancer and the second leading cause of death from cancer among women after lung cancer."  Consequently, challenging the usefulness of a long-used screening procedure--mammogram--has spurred heated debate among, physicians and academics.

The task force cites evidence that harms attendant to annual exams beginning at age 40 outweigh the potential benefits.  As the Post report states, mammograms "produce false-positive results in about 10 percent of cases, causing anxiety and often prompting women to undergo unnecessary follow-up tests, sometimes-disfiguring biopsies, and unneeded treatment, including surgery, radiation and chemotherapy."  Having said that, the American Cancer Society, the American College of Radiology, and others assert that the benefits greatly outweigh the potential dangers. 

Daniel B. Kopans, a professor of radiology at Harvard Medical School, is quoted in the report, saying, "Tens of thousands of lives are being saved by mammography screening, and these idiots want to do away with it...It's crazy -- unethical, really."

According to the report, the American Cancer Society has not indicated a desire to change its guidelines, but the National Cancer Institute said it would re-evaluate its recommendations.

We urge our readers to speak with their doctors and make individual decisions about what is best for your health.  It may be appropriate if not necessary for some women to have annual mammograms in light of their family history, for instance.  Others may be doing more harm than good by exposing themselves to annual mammograms.  Doctors should know what is best for each individual and should advise their patients accordingly so that women can make the best decisions that they can, and so their long-term health can be promoted.

To read the full Post article, please click here.

About the author:

Mr. Zambri is Past-President of the Trial Lawyers Association of Metropolitan Washington, DC and has been rated by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all lawyers in the Washington metropolitan area.  The magazine also describes him as "one of Washington's best--most honest and effective lawyers" who specializes in personal injury matters, including medical malpractice actions stemming from misdiagnosed cancer and dangerous drugs.  He has also been named a "DC Super Lawyer" by Super Lawyer magazine (March/April 2009)--a national publication that honors the top lawyers in America.  If you need a patient advocate, we recommend that you read an article about medical malpractice claims authored by senior partner Salvatore Zambri.

If you want more information about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.

Posted In Cancer Misdiagnosis , Medical Malpractice , Men's Health Issues , Nursing Home Negligence , Patient Safety , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Drug Warning: Vials of Genzyme Drugs Potentially Contaminated

Posted by: Salvatore J. Zambri, Esquire

The New York Times reported that according to the US Food and Drug Administration (FDA), "Vials of five different Genzyme drugs for rare diseases may be contaminated with tiny particles of steel, rubber or fiber that could potentially harm patients."  However, "the FDA and Genzyme said that there had been no reports of patients being harmed by particles and that the problem affected less than one percent of the vials."  Although Dr. Jason Woo, an FDA official, stated, "We do not believe this is a wide-scale problem, but we do not have information that fully defines the scope," patients and doctors are concerned.

According to the report, the FDA has confirmed that "the products would remain on the market, because there are few alternative treatments," the AP (11/14, Perrone) reported. The agency has strongly advised physicians to "closely inspect vials for particles before injecting them into patients."  If exposed to contaminated vials, patients may experience "potential allergic reactions, blood clots, and other problems," states the report. 

 About the author:

Mr. Zambri is Past-President of the Trial Lawyers Association of Metropolitan Washington, DC and has been rated by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all lawyers in the Washington metropolitan area.  The magazine also describes him as "one of Washington's best--most honest and effective lawyers" who specializes in personal injury matters, including medical malpractice actions stemming from defective or dangerous medications.   He has also been named a "DC Super Lawyer" by Super Lawyer magazine (March/April 2009)--a national publication that honors the top lawyers in America.  If you need a patient advocate, we recommend that you read an article about medical malpractice claims authored by senior partner Salvatore Zambri.

If you want more information about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.


 

Posted In Medical Malpractice , Medications , Men's Health Issues , Nursing Home Negligence , Obstetrics , Patient Safety , Pediatrics , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Multiple Sclerosis Drug Tysabri Linked to Lethal Brain Inflammation

Posted by: Salvatore J. Zambri, Esquire

The Associated Press (AP) recently reported that the Food and Drug Administration (FDA) "says it confirmed three new cases of a potentially lethal brain inflammation linked to the multiple sclerosis drug Tysabri [natalizumab]."  According to the FDA, the reports "are the first confirmed new cases since June."  The condition is known as progressive multifocal leukoencephalopathy, or PML.  The report states that the FDA has confirmed that since mid-2006 there have been 13 reported cases of PML.  The AP adds that "the FDA says the risk appears to increase as patients remain on Tysabri" and all "the PML cases are linked to its use in multiple sclerosis," although the drug is also marketed to treat Chron's disease as well.

According to the AP report, Tysabri  "was approved in November 2004 and pulled from the market the next year due to PML reports. It was reintroduced in July 2006, and Biogen said it is used by 43,000 patients."

Like all drugs, Tysabri, which is marketed by Biogen Idec Inc. and Elan Corp. PLC, should never be taken without a doctor's prescription, and a physician should never prescribe this medication unless it is in the best interest of the patient and only after the patient has been fully informed of all of the risks and benefits of the drug.
 

About the author:

Mr. Zambri is Past-President of the Trial Lawyers Association of Metropolitan Washington, DC and has been rated by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all lawyers in the Washington metropolitan area.  The magazine also describes him as "one of Washington's best--most honest and effective lawyers" who specializes in personal injury matters, including medical malpractice actions stemming from defective or dangerous medications.   He has also been named a "DC Super Lawyer" by Super Lawyer magazine (March/April 2009)--a national publication that honors the top lawyers in America.  If you need a patient advocate, we recommend that you read an article about medical malpractice claims authored by senior partner Salvatore Zambri.

If you want more information about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.

Posted In Medical Malpractice , Medications , Men's Health Issues , Patient Safety , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Drugmaker Hid Dangers of Drug from Public to Pad Profits

Posted by: Salvatore J. Zambri, Esquire

According to a Bloomberg report, a former GlaxoSmithKline executive testified under oath that the drug company knew as early as 2001 that its anti-depressant drug--Paxil--could cause birth defects in the fetuses of pregnant women.  It has been alleged that this information was withheld from the public so the company could maximize profits at teh expense of public health.  The reports notes that in a videotaped deposition, former Glaxo drug-safety executive Jane Nieman stated that the company was “almost certain” by 2001 that Paxil was to blame for a certain heart defect that caused women to abort their fetuses. 

The drug generated about $942 million in sales last year alone.   We have no problem with companies making money--that's America.  What's un-American is putting profits over people.  No company should ever risk public health in a greedy effort to pad profits.  Many lawsuits against the drug manufacturer are pending, and we expect that the truth will be revealed and that the victims' suits will help protect all Americans from corporate greed. 

 About the author:

Mr. Zambri is Past-President of the Trial Lawyers Association of Metropolitan Washington, DC and has been rated by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all lawyers in the Washington metropolitan area.  The magazine also describes him as "one of Washington's best--most honest and effective lawyers" who specializes in personal injury matters, including medical malpractice actions stemming from defective or dangerous medications.   He has also been named a "DC Super Lawyer" by Super Lawyer magazine (March/April 2009)--a national publication that honors the top lawyers in America.  If you need a patient advocate, we recommend that you read an article about medical malpractice claims authored by senior partner Salvatore Zambri.

If you want more information about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.

 


 

Posted In Medical Malpractice , Men's Health Issues , Patient Safety , Product Liability , Public Health , Tort Reform , U.S. Food and Drug Administration Warnings , Women's Health Issues
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FDA Mandates "Black Box" Warning for Promethazine

Posted by: Salvatore J. Zambri, Esquire

The AP (9/17, Johnson) reports that the FDA has determined that "[m]akers of injected promethazine, a sedative also used to treat nausea and vomiting, are being required to put the strongest warning possible on the product because it can cause tissue damage leading to amputation." FDA regulators said that "makers of generic promethazine will have to put a 'black box' warning at the top of the detailed package insert explaining that when the drug is administered incorrectly, it can damage skin severely, including causing gangrene."

We urge our readers to be very careful when taking this drug.  It is vitally important that you refrain from using it unless directed by a doctor, who is responsible for understanding all of the risks and benefits of the drug.  The risks should be communicated to you by your doctor before the physician prescribes the medication.
 

About the author:

Mr. Zambri is Past-President of the Trial Lawyers Association of Metropolitan Washington, DC and has been rated by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all lawyers in the Washington metropolitan area.  The magazine also describes him as "one of Washington's best--most honest and effective lawyers" who specializes in personal injury matters, including medical malpractice actions stemming from defective or dangerous medications.   He has also been named a "DC Super Lawyer" by Super Lawyer magazine (March/April 2009)--a national publication that honors the top lawyers in America.  If you need a patient advocate, we recommend that you read an article about medical malpractice claims authored by senior partner Salvatore Zambri.

If you want more information about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.

Posted In Medical Malpractice , Medications , Men's Health Issues , Patient Safety , Pediatrics , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Study Suggests Hormone Therapy Increases Risk of Ovarian Cancer

Posted by: Salvatore J. Zambri, Esquire

According to a recent Danish study, women who undergo hormone replacement therapy after menopause are at a meaningfully higher risk of developing ovarian cancer.  A Reuters report states that the study, published in the Journal of the American Medical Association, comments that women who took hormone replacements were 38 percent more likely to develop ovarian cancer than those who did not.  This follows a study that was conducted ion 2002 by the Women’s Health Initiative, which produced similar findings.

We encourage our readers to be very careful when taking any medication.  No women should undergo hormone replacement therapy or other kind of therapy without first seeking the advice of medical experts.  Doctors should warn patients of potential side-effects and should not prescribe drugs unless it is proper to do so in light of all risks and benefits.

About the author:

Mr. Zambri has been rated by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all lawyers in the Washington metropolitan area.  The magazine also describes him as "one of Washington's best--most honest and effective lawyers" who specializes in personal injury matters, including medical malpractice actions.   He has also been named a "DC Super Lawyer" by Super Lawyer magazine (March/April 2009)--a national publication that honors the top lawyers in America.  Our firm has experience pursing cases for patients that involve dangerous medical products, as well as claims involving inappropriately prescribed medications.  If you need a patient advocate, we recommend that you read an article about medical malpractice claims authored by senior partner Salvatore Zambri.

If you want more information about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899. 

 

Posted In Cancer Misdiagnosis , Medical Malpractice , Medications , Patient Safety , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Bayer Sued Over Its Oral Contraceptive--Yaz

Posted by: Salvatore J. Zambri, Esquire

Bayer reached an agreement with the Food and Drug Administration (FDA) in 2008, forcing the company to pay for a $20 million ad campaign to correct the company's history of overstating the benefits of its oral contraceptive--Yaz--and downplaying its risks.  The FDA determined that Yaz carries additional risks as compared to other contraceptives because the drug contains drospirenone, a progestin, which can increase a woman's potassium to dangerous levels.  Increased levels of potassium can lead to many adverse side-effects including blot clots, which can then lead to stroke, heart attack, or other serious condition. 

Before taking any drug, please be sure to consult with your doctor and pharmacist.  Physicians must take affirmative steps to be aware of all side-effects of the medications they prescribe so their patients do not suffer adverse, otherwise avoidable, consequences.

About the author:

Mr. Zambri has been rated by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all lawyers in the Washington metropolitan area.  The magazine also describes him as "one of Washington's best--most honest and effective lawyers" who specializes in personal injury matters, including medical malpractice actions.   He has also been named a "DC Super Lawyer" by Super Lawyer magazine (March/April 2009)--a national publication that honors the top lawyers in America.  Our firm has experience pursing cases for patients that involve dangerous medical products.  If you need a patient advocate, we recommend that you read an article about medical malpractice claims authored by senior partner Salvatore Zambri.

If you want more information about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899. 

Posted In Medical Malpractice , Medications , Obstetrics , Patient Safety , Pediatrics , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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FDA Warning: Don't Purchase or Use New Whey Liquid Products or Hardcore Energize Bullet

Posted by: Salvatore J. Zambri, Esquire

The FDA has warned consumers not to buy or use Hardcore Energize Bullet or New Whey liquid products sold in test tube-like vials, as a result of suspected product tampering. The products are being recalled.

According to the FDA, "The suspected tampering involved a utility knife blade found in one vial of Hardcore Energize Bullet drink, manufactured in the United States and sold in Canada, and another blade in one vial of New Whey liquid products, manufactured and sold in the United States."

Both of the products--Hardcore Energize Bullet and New Whey liquid products--are manufactured by Protica Inc., of Whitehall, Pa. The company is investigating this incident.

To read the entire warning, click here.

Do not use or purchase these items.  To do so would expose you to serious health risks.  Be safe.

About the author:

Mr. Zambri has been rated by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all lawyers in the Washington metropolitan area.  The magazine also describes him as "one of Washington's best--most honest and effective lawyers" who specializes in personal injury matters, including medical malpractice actions.   He has also been named a "DC Super Lawyer" by Super Lawyer magazine (March/April 2009)--a national publication that honors the top lawyers in America.  Our firm has experience pursing cases for patients that involve tragic medical errors, including the failure to properly inform patients of abnormal test results.  If you need a patient advocate, we recommend that you read an article about medical malpractice claims authored by senior partner Salvatore Zambri.

If you want more information about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.

Posted In Medical Malpractice , Medications , Men's Health Issues , Patient Safety , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Doctors Fail to Report Abnormal Test Results At Alarming Rate

Posted by: Salvatore J. Zambri, Esquire

Doctors fail to report clinically significant findings to their patients in more than seven percent (7%) of the cases, according to the Associated Press, relying on a new study published Monday in the Archives of Internal Medicine.  Physicians' use of electronic medical records tended to lower instances of failures to inform.  The frequency of errors is higher in practices that used a combination of electronic and paper records, as opposed to practices that relied on only paper or only electronic records, reports Nicholas Bakalar of the New York Times.    

We encourage doctors to utilize the electronic technology now available to better communicate with patients and other physicians regarding a patient's symptoms and conditions.  Reckless record-keeping leads to needless deaths and injuries.  There is a crisis in this country--too many Americans die each year as a result of hospital and doctor errors.  Nearly 100,000 people die every year as a result of hospital mistakes alone.  Safety needs to be a priority as we move forward.

About the author:

Mr. Zambri has been rated by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all lawyers in the Washington metropolitan area.  The magazine also describes him as "one of Washington's best--most honest and effective lawyers" who specializes in personal injury matters.  He has successfully litigated multiple cases against Metro and other automobile owners.  He has also been named a "Super Lawyer" by Super Lawyer magazine.  Our firm has experience pursing cases for patients that involve tragic medical errors, including the failure to properly inform patients of abnormal test results.  If you need a patient advocate, we recommend that you read an article about medical malpractice claims authored by senior partner Salvatore Zambri.

If you want more information about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.

Posted In Cancer Misdiagnosis , Cerebral Palsy , Medical Malpractice , Medications , Men's Health Issues , Nursing Home Negligence , Obstetrics , Patient Safety , Pediatrics , Product Liability , Public Health , Tort Reform , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Matrixx Withheld Consumer Complaints

Posted by: Salvatore J. Zambri, Esquire

Shannon Pettypiece reports for Bloomberg that Matrixx Initiatives Inc. announced that it failed to turn over to U.S. regulators about 800 consumer complaints concerning serious side-effects linked to its Zicam nasal spray and swabs, which have been withdrawn.

According to the report, "Matrixx, based in Scottsdale, Arizona, stopped selling the cold remedies on June 16 after the Food and Drug Administration warned consumers the treatments may cause a loss of smell. Matrixx today defended its products and called the FDA warning 'a surprise,' during a conference call with analysts."

The 800 complaints were unearthed only after the FDA performed a routine inspection found 800 reports of consumer concerns this past May.  William Hemelt, acting president and chief operating officer of Matrixx, said that he was informed that  his compnay did not need to report the complaints despite a 2007 regulation requiring companies to turn over reports of serious side effects, arguing that the regulation didn't apply. 

“We have complaints but we weren’t required to send them,” Hemelt said. “At least we didn’t believe we were required to send them and we based that on an opinion of counsel who looked at the FDA regulation and said no, it doesn’t fit.”

The FDA reported that doctors and consumers have linked a permanent loss of smell to the us of the medications.

When companies withhold critically important information it smacks of putting profits over people.  Safety and public health should always be the paramount concern of drug companies. 

Our firm has experience pursing cases for patients that involve tragic medication errorspharmacy mix ups and unsafe medications.  If you think you have been injured by a defective product, we encourage you to read a portion of a book regarding products liability authored by senior partner Salvatore Zambri.

For information about your legal rights, please contact Mr. Zambri at 202-822-1899 or email him at szambri@reganfirm.com.

Posted In Cancer Misdiagnosis , Medical Malpractice , Medications , Men's Health Issues , Obstetrics , Patient Safety , Pediatrics , Product Liability , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Medical Device Oversight Required

Posted by: Salvatore J. Zambri, Esquire 

According to a Reuters article, reported by James Pethkoukis, experts have determined that the FDA's approval process needs to be improved to better protect patients from dangerous risks.

At a congressional hearing, Representative Frank Pallone, who chairs a House Energy and Commerce subcommittee, stated, "There is evidence of an approval system that is broken -- that its standards, its procedures and its rules don't meet modern needs of getting medical devices to those in need with confidence in their safety." The article further comments that "Marcia Crosse, healthcare director for the nonpartisan Government Accountability Office, said various shortcomings 'raise concerns' about the FDA's pre-approval reviews and post-approval monitoring 'that are necessary for ensuring the safety and effectiveness of medical devices.'"

Although Americans benefit greatly from new products, the FDA must do more to protect those who will be using the products in the end--the patients. Without serious oversight, great harm can result.

Our firm has experience pursing cases for patients that involve tragic medication errors, pharmacy mix ups and unsafe medications.  If you think you have been injured by a defective product, we encourage you to read a portion of a book regarding products liability  authored by senior partner Salvatore Zambri.

For information about your legal rights, please click here or contact Mr. Zambri at 202-822-1899.

Posted In Cancer Misdiagnosis , Medical Malpractice , Medications , Men's Health Issues , Patient Safety , Pediatrics , Product Liability , U.S. Food and Drug Administration Warnings
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Medtronic Pacemakers Recalled Due to Wire Separation Problems

Some of Medtronic's pacemakers have been recalled because wires connecting the electronic circuit to other components could separate — potentially leading to serious injury or death.

The class 1 recall, the agency's most serious type, affects more than 21,000 Kappa (600/700/900 Series) and Sigma (100/200/300 Series) pacemakers. Most were implanted at least 5 years ago.

We have reproduced the FDA Press Release in its entirety:
FDA NEWS RELEASE

For Immediate Release: June 11, 2009

Media Inquiries: Peper Long, 301-796-4671, mary.long@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA Alerts Patients to Medtronic Pacemaker Recall

The U.S. Food and Drug Administration is alerting patients to the Class I recall of certain Medtronic Kappa and Sigma pacemakers. These devices may fail due to a separation of wires that connect the electronic circuit to other pacemaker components, such as the battery.

Patients with malfunctioning pacemakers may experience a return of symptoms associated with abnormal heart rate, such as fainting or lightheadedness. In rare cases, pacemaker-dependent patients may experience serious injury or even death.

There are more than 1.7 million Kappa or Sigma pacemakers implanted in patients throughout the world. Of those, only about 21,000 pacemakers are affected by this recall, most of which have been implanted in patients for five years or longer.

Medtronic Inc. issued a letter to physicians alerting them to this problem on May 18. The company communicated with patients via letter on May 27.

The affected pacemakers are Kappa Series 600/700/900 and Sigma Series 100/200/300. Patients with these models of Kappa and Sigma pacemakers should determine if their pacemaker is part of this recall by contacting Medtronic at 800-505-4636 or going to their Web site at http://www.KappaSigmaSNList.medtronic.com.

Patients who have these recalled pacemakers and those who are unsure if their pacemakers are affected should follow up with their primary care physician or cardiologist.

Through standard medical device reporting requirements, the FDA became aware of possible problems and worked with the company to address them. The FDA classified this voluntary recall as Class I, indicating reasonable probability that the use of the device will cause serious adverse health consequences or death.

For more information:
Consumer article

 

Posted In U.S. Food and Drug Administration Warnings
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FDA Warns of Dangers of Sirolimus (Rapamune) for Liver Transplant Patients

Posted by: Salvatore J. Zambri, Esquire and Catherine Bertram, Esquire

Recently, MedPage Today reported that "The FDA issued an alert regarding the risk of increased mortality in stable liver transplant patients who switch from a calcineurin inhibitor-based (CNI) immunosuppressive regimen to sirolimus (Rapamune)."  It was noted, however, "that a causal relationship has not been established and that" the FDA "is not recommending discontinuation of the drug, which is indicated for prevention of organ rejection in kidney transplant recipients older than 12."

The label for the drug "already carries a boxed warning of excess mortality and graft loss associated with the use of" sirolimus "in combination with tacrolimus (Prograf) in de novo liver and lung transplant recipients."  And it also warns that it is not clear that the drug is safe for liver or lung transplant patients.  Doctors, therefore, should heed those warnings, comments the FDA.  Prescribing medication in a way that is contrary to the labeling may lead to serious permanent injury or death.

Our firm has experience pursing cases for patients that involve tragic medication errorspharmacy mix ups and unsafe medications.  If you think you have been injured by a defective product, we encourage you to read a portion of a book regarding products liability authored by senior partner Salvatore Zambri.

For information about your legal rights, please click here or contact us at Regan Zambri & Long, PLLC at 202-463-3030. 

Posted In Medical Malpractice , Medications , Men's Health Issues , Obstetrics , Patient Safety , Pediatrics , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Cholesterol-type Not Usually Screened May Cause Heart Attack

Posted by: Salvatore J. Zambri, Esquire and Catherine Bertram, Esquire

Medical News Today recently reported that a certain kind of cholesterol--known as lipoprotein (a)--may increase the risk of heart attack (medically referred to as myocardial infarction, or MI).  This type of cholesterol, says the article, has been screened little.  Historically, doctors ahve been screening patients for low-denisty lipoproteins, commonly called "bad protein".  Nevertheless, MI has continued to be a leading cause of death.  As a result, scientists have been looking at other caused of heart disease.

The theory about lipoprotein (a) leading to heart disease stems from a study of people living in Denmark, who had higher levels of lipoprotein (a) due to genetic reasons, and who were at a higher risk of heart attack.  The article comments that the "researchers suggested that although their findings were strong enough to support the idea that higher levels of lipoprotein (a) due to genetic reasons very probably cause higher risk of heart attack, only randomized clinical trials that show fewer heart attacks occur when lipoprotein (a) is reduced through therapy can prove it."  So, expect more studies.

According to the report, representatives of "the National Heart, Lung and Blood Institute's Framingham Heart Study commented that although Kamstrup and colleagues revealed some 'interesting mechanistic insights' into the biological link between lipoprotein (a) and MI, and put forward evidence that there might be potential benefit in reducing lipoprotein (a) early in life, the 'clinical implications are quite limited.'"

Before taking any medication, we encourage you to seek the advice of competent physicians. 

Our firm has experience pursing cases for patients that involvee tragic medication errorspharmacy mix ups and unsafe medications.  If you think you have been injured by a defective product, we encourage you to read a portion of a book regarding products liability authored by senior partner Salvatore Zambri.

For information about your legal rights, please click here or contact us at Regan Zambri & Long, PLLC at 202-463-3030.

Posted In Medical Malpractice , Medications , Men's Health Issues , Patient Safety , Pediatrics , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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FDA Issues Warnings About Clarcon Skin Products

Posted by: Salvatore J. Zambri, Esquire and Catherine Bertram, Esquire

The AP recently reported that  "The Food and Drug Administration warned consumers Monday not to use skin products made by Clarcon." This warning followed a recent inspection which revealed high levels of disease-causing bacteria in the products.  According to the report, the FDA has said that the findings are "particularly concerning because the products are promoted as antimicrobial agents that claim to treat open wounds and damaged skin and protect against various infectious diseases."  Yet, according to the report, some of the bacteria found in the products "can cause opportunistic infections of the skin and underlying tissues and could result in medical or surgical attention as well as permanent damage," the report comments.

Our firm has experience pursing cases for patients that involve tragic medication errorspharmacy mix ups and unsafe medications.  If you think you have been injured by a defective product, we encourage you to read a portion of a book regarding products liability authored by senior partner Salvatore Zambri.

For information about your legal rights, please click here or contact us at Regan Zambri & Long, PLLC at 202-463-3030.


 

Posted In Cancer Misdiagnosis , Medical Malpractice , Medications , Men's Health Issues , Obstetrics , Patient Safety , Pediatrics , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Merck & Co., Schering-Plough Accused of Fraud

Posted by: Salvatore J. Zambri, Esquire and Catherine Bertram, Esquire

Bloomberg News reports that "Merck & Co. and Schering-Plough Corp. were sued by a Pennsylvania fund for active and retired state employees over claims they misled consumers into paying too much for prescriptions of Zetia [ezetimibe] and Vytorin cholesterol pills."  The Pennsylvania Employees Benefit Trust Fund alleges in a complaint that "the companies have known for years -- and failed to make public -- that Zetia doesn't reduce fatty arterial plaques that can cause heart attacks and strokes."  The reports commenst that two studies last year showed that "the pills may work no better at unclogging arteries than does an older, cheaper medicine called simvastatin." Nevertheless, the companies allegedly withheld the the finding and "used false and deceptive marketing techniques claiming Vytorin was more efficacious than and just as safe as the much cheaper generic," according to the report.

Our firm has experience pursing cases for patients that involve tragic medication errorspharmacy mix ups and unsafe medications.  If you think you have been injured by a defective product, we encourage you to read a portion of a book regarding products liability authored by senior partner Salvatore Zambri.

For information about your legal rights, please click here or contact us at Regan Zambri & Long, PLLC at 202-463-3030.

Posted In Cancer Misdiagnosis , Medical Malpractice , Medications , Obstetrics , Patient Safety , Pediatrics , Product Liability , Public Health , Tort Reform , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Dirty Syringes From Plant Kill and Injure: FDA Could Have Intervened

Posted by: Salvatore J. Zambri, Esquire and Catherine Bertram, Esquire

Natalie Fullerton's father feels like he is responsible for the death of his child, but he's not.  After a successful lung transplant, Natalie was thriving.  Her loving father tirelessly cared for her post-surgery, administering medication with the use of syringes.  The syringes, however, were manufactured at a factory owned by a Lake Zurich businessman.  And they were contaminated.  Natalie died.  She was 2 1/2 years old.

The tainted syringes from the plant are now "linked to four deaths and 162 illnesses nationwide, including 22 in Illinois", according to ChicagoTribune.com.  The report comments that "an examination of inspection reports and other documents shows that the U.S. Food and Drug Administration missed several chances to stop the tainted syringes from being used by patients."

According to the article, just three months before the contaminated syringes were shipped (in October 2007), "an FDA inspector visited the plant in North Carolina where they were made. She investigated reports of red, brown and black particles in syringes and reported that managers had a plan to deal with rust."  Those plans were either faulty or non-existent, and teh FDA did not follow-up sufficiently it is suggested.

"A week later, when the FDA learned a distributor was recalling 1.3 million of the syringes, the agency should have launched a thorough inspection, according to its operations manual. That didn't happen, an FDA spokeswoman now says, because the agency is so understaffed it no longer follows the policy unless the recalled product poses a reasonable probability of serious injuries or deaths."

The bacteria on the syringes never should have entered the marketplace.  And, unfortunately, there is plenty of blame to go around.  The owner of the plant is now a fugitive of law.  He fled the country and is trying to evade charges that could land him 95 years on prison.

When dispensing medical devices, medical providers must be sure they are sterilized.  Manufacturers and distributors must do the same.  Natalie may not be the last victim of corporate greed and carelessness, but the FDA must do more to protect Americans of all ages.  That's what we pay them to do.

Our firm has experience pursing cases for patients that involve tragic medication or other medical errors.   If you think your providers have ignored your symptoms, we encourage you to read an article regarding medical malpractice authored by senior partner Salvatore Zambri.

For information about your legal rights, please click here or contact us at Regan Zambri & Long, PLLC at 202-463-3030.

 

 

Posted In Medical Malpractice , Medications , Men's Health Issues , Patient Safety , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Atypical Antipsychotic Medications Effective But Risky for Children

Posted by: Salvatore J. Zambri, Esquire and Catherine Bertram, Esquire

According to the The Wall Street Journal, staff from the Food and Drug Administration (FDA) indicate that three medications "currently approved to treat bipolar disorder and schizophrenia in adults were effective at treating the disorders in children and adolescents, but carry significant risks." As a result, the FDA is now "considering applications for AstraZeneca PLC's Seroquel [quetiapine] and Eli Lilly and Co.'s Zyprexa [olanzapine] to treat bipolar disorder and schizophrenia in children and adolescents, and Pfizer, Inc.'s Geodon [ziprasidone] to treat bipolar disorder in children 10 to 17," comments the report.  In fact, "an FDA panel of outside medical experts is scheduled to meet to discuss" these atypical antipsychotic medications, and will be "asked to vote on whether each product is safe and effective for children ages 10 to 17."  The report goes on the add that the FDA and the drug-makers announced that "studies showed the products were effective at treating the symptoms of bipolar and schizophrenia," but also warned that "all had side effects."  These sides effects include "sedation and weight gain."

We encourage our readers to speak with their doctors before taking any medication.  Mixing drugs can be particularly dangerous.  Some drugs pose greater health risks than others.  Relying, too, on what the FDA reports and what the drug-makers themselves state about their own medications may not be sufficient.

Our firm has experience pursing cases for patients that involve tragic medication errorspharmacy mix ups and unsafe medications.  If you think you have been injured by a defective product, we encourage you to read a portion of a book regarding products liability authored by senior partner Salvatore Zambri.

For information about your legal rights, please click here or contact us at Regan Zambri & Long, PLLC at 202-463-3030.

Posted In Medical Malpractice , Medications , Men's Health Issues , Obstetrics , Patient Safety , Pediatrics , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Propylthiouracil Poses Serious Liver Injury

Posted by: Salvatore J. Zambri, Esquire and Catherine Bertram, Esquire

An U.S. Department of Health and Human Services (HHS) report confirms that, two days ago, the U.S. Food and Drug Administration (FDA) "warned health care professionals about the risk of serious liver injury associated with the use of the anti-thyroid drug propylthiouracil for the treatment of Graves' disease."  Citing the FDA, HHS reports that: "After analyzing adverse event reports, the FDA has identified an increased risk of liver injury with propylthiouracil when compared to an alternative treatment for Graves' disease, methimazole," said Amy Egan, M.D., deputy director for safety, Division of Metabolism and Endocrinology Products, in the FDA’s Center for Drug Evaluation and Research. "Health care professionals should carefully consider which drug to initiate in a patient recently diagnosed with Graves' disease. If propylthiouracil therapy is chosen, the patient should be closely monitored for symptoms and signs of liver injury, especially during the first six months after initiating therapy."

Graves' disease is an autoimmune disorder which causes the thyroid gland to be overactive. The thyroid gland releases hormones that regulate the rate of the body’s metabolism.  These hormones "are critical for body temperature control, energy, weight, mood, and blood calcium levels."

Medications can have serious side-effects, especially if warnings and precautions are not taken seriously. Doctors should fully inform patients of all risks associated with prescribed medications and patients should never hesitate to ask their doctors for more information if they are confused about the risks of certian medications.

Our firm has experience pursing cases for patients that involve tragic medication errorspharmacy mix ups and unsafe medications.  If you think you have been injured by a defective product, we encourage you to read a portion of a book regarding products liability authored by senior partner Salvatore Zambri.

For information about your legal rights, please click here or contact us at Regan Zambri & Long, PLLC at 202-463-3030.

Posted In Cancer Misdiagnosis , Medical Malpractice , Medications , Men's Health Issues , Obstetrics , Patient Safety , Pediatrics , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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FDA May Require More Warnings on Tamoxifen Label

Posted by: Salvatore J. Zambri, Esquire and Catherine Bertram, Esquire

We recently posted a blog informing our readers that a Bloomberg report announced that  researches have determined that certain antidepressants may increase the recurrence  of breast cancer among women who have already survived the disease.  The study reports that drugs including Prozac, Paxil and Zoloft "significantly decrease the effectiveness of a drug [tamoxifen] used to reduce the chances of breast cancer recurrence". 

A new Bloomberg report of yesterday confirms that "US regulators may warn patients taking tamoxifen, a breast cancer medicine...not to use certain types of antidepressants because they block the tumor-fighting drug's effectiveness." Karen Riley, a spokeswoman for the Food and Drug Administration, commented that the agency is considering "'adding new information to the tamoxifen label to advise women taking the cancer drug against using some antidepressants."

Ms. Riley's comments are welcomed, but action is what is needed.  The public must be warned of the harmful effects of mixing these drugs.  It could be a matter of life and death.

Our firm has experience pursing cases for patients that involve tragic medication errorspharmacy mix ups and unsafe medications.  If you think you have been injured by a defective product, we encourage you to read a portion of a book regarding products liability authored by senior partner Salvatore Zambri.

For information about your legal rights, please click here or contact us at Regan Zambri & Long, PLLC at 202-463-3030.

Posted In Medical Malpractice , Medications , Men's Health Issues , Patient Safety , Pediatrics , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Class 1 Recall: Respironics, Inc., SmartMonitor 2 Infant Apnea Monitor (Models 4002 and 4003)

"Respironics and FDA notified healthcare professionals of a Class I recall of SmartMonitor 2 Infant Apnea Monitor, Models 4002 and 4003, used for the continuous monitoring of respiration and heart rate of infant patients in the home or in the hospital. The monitors may fail to sound an alarm during periods of temporary interruption of breathing or low heart rates. The affected products were manufactured from January 16, 2008 through November 13, 2008 and distributed from January 17, 2008 through December 31, 2008."

Read the complete MedWatch 2009 Safety summary, including a link to the FDA recall notice.

We have reproduced the FDA Recall Notice in its entirety for our readers below:

"Date Recall Initiated: April 23, 2009
Product: Respironics, Inc., SmartMonitor 2 Infant Apnea Monitor (Models 4002 and 4003 with serial numbers 3000033364 through 3000038740)  This product was manufactured from January 16, 2008 through November 13, 2008 and distributed from January 17, 2008 through December 31, 2008.
Use: This device is used for the continuous monitoring of respiration and heart rate of infant patients in the home or in the hospital. The monitor detects and alarms for periods of temporary interruption of breathing (central apnea) or low heart rates.
Recalling Firm: 
Respironics, Inc.
1001 Murry Ridge Lane
Murrysville, Pennsylvania 15668-8517
Reason for Recall:  This device may fail to sound an alarm.
Public Contact: Customers may contact the company at 1-888-345-4630.
FDA District:
Philadelphia
FDA Comments: On April 23, 2009, the firm sent a letter to their medical supply companies informing them of the potential problem. The firm requested the companies take the following actions:

  • return all units in their inventory
  • retrieve and return all units already shipped to patients

Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious injury or death.

Health care professionals and consumers may report adverse reactions or quality problems experienced with the use of these products to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by FAX.

  • Online: www.fda.gov/MedWatch/report.htm
  • Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm
  • Mail to MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787
  • FAX: 1-800-FDA-0178

Updated May 18, 2009"

 

Posted In Patient Safety , Pediatrics , U.S. Food and Drug Administration Warnings
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Tarceva Warnings Added

Posted by: Salvatore J. Zambri, Esquire and Catherine Bertram, Esquire

The Food and Drug Administration (FDA), along with manufacturers OSI and Genentech, notified healthcare professionals of new safety information that has been added to the " WARNINGS AND PRECAUTIONS" sections of the prescribing information for Tarceva.  The FDA reports that "[g]astrointestinal perforation (including fatalities), bullous, blistering and exfoliative skin conditions including cases suggestive of Stevens-Johnson syndrome/toxic epidermal necrolysis, in some cases fatal, and ocular disorders, including corneal perforation or ulceration have been reported during use of Tarceva." (emphasis added).  Tarceva has been used to treat patients with certain kinds of lung cancer after at least one prior chemotherapy regimen proved to be unsuccessful.  It has also been prescribed to treat patients with pancreatic cancer.

To read the entire FDA report, please click here.

Medications can have serious side-effects, especially if warnings and precautions are not taken seriously. Doctors should fully inform patients of all risks associated with prescribed medications and patients should never hesitate to ask their doctors for more information if they are confused about the risks of certian medications.

Our firm has experience pursing cases for patients that involve tragic medication errorspharmacy mix ups and unsafe medications.  If you think you have been injured by a defective product, we encourage you to read a portion of a book regarding products liability authored by senior partner Salvatore Zambri.

For information about your legal rights, please click here or contact us at Regan Zambri & Long, PLLC at 202-463-3030.

Posted In Medical Malpractice , Medications , Men's Health Issues , Patient Safety , Product Liability , U.S. Food and Drug Administration Warnings , Women's Health Issues
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FDA Recalls Biosite'sTriage Cardiac Panel

Posted by: Salvatore J. Zambri, Esquire and Catherine Bertram, Esquire

The Food and Drug Administration (FDA) reports that Biosite and the FDA have notified medical professionals of a Class 1 recall of the Biosite-brand Triage Cardiac Panel.  This particular panel is a test used by healthcare specialists to diagnose a heart attack (myocardial infarction).  However, according to the FDA, the "use of the affected lot may lead to false negative results with patient samples containing troponin I at very low levels, with CK-MB, and with myoglobin, possibly resulting in missed or incorrect diagnosis. A false negative test result would indicate that a person has not had a heart attack or heart muscle injury when in fact they have."

All Biosite customers must stop using all Biosite-brand Triage Cardiac Panels immediately.  Reliance upon these defective tests can lead to mistreatment of people with otherwise treatable heart conditions.

To read the entire recall, please click here.

Our firm has experience pursing cases for patients that involve tragic medication errorspharmacy mix ups and unsafe medications.  If you think you have been injured by a defective product, we encourage you to read a portion of a book regarding products liability authored by senior partner Salvatore Zambri.

For information about your legal rights, please click here or contact us at Regan Zambri & Long, PLLC at 202-463-3030.

Posted In Medical Malpractice , Men's Health Issues , Obstetrics , Patient Safety , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Two Delaware Patients Die from Taking Heparin

By Catherine D. Bertram, Esquire and Salvatore J. Zambri, Esquire

The Wall Street Journal reports, "Two Delaware patients died last weekend after taking heparin, a widely used blood thinner made by Baxter International Inc., sparking concerns about a repeat of fatal heparin contamination in 2008." Baxter is quoted in the article as stating that "the heparin involved in the cases of the two patients who died is from North American-derived bulk material supplied by Pfizer Inc. In the heparin deaths last year, the bulk material came from China."  According to the press statements, the FDA has "sent medical teams to Delaware, and an FDA agent drove samples of the heparin bags directly to an agency laboratory in Queens, New York."

According to the Chicago Tribune (5/12, Japsen) the hospital where the incidents occurred, the Beebe Medical Center has suspended the use of heparin. "Adverse reactions were reported in five patients who had problems that included internal bleeding in the brain."  It was reported that the new complications involve premixed intravenous bags of heparin. Last year's problems involved bulk supplies, vials of the medicine and drug-coated medical devices.

Continue Reading Posted In Medications , Patient Safety , U.S. Food and Drug Administration Warnings
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Hearing Tomorrow On Medical Device Safety Act of 2009

Posted by: Salvatore J. Zambri, Esquire and Catherine Bertram, Esquire

The Subcommittee on Health will hold a hearing tomorrow regarding The Medical Device Safety Act of 2009.   This is an important piece of legislation that should become law.  We encourage our readers to contact their representatives in Congress and urge them to vote in favor of the bill.

The Medical Device Safety Act of 2009 is important for two principal reasons.  First, it will allow every American patient to hold manufacturers of defective medical devices accountable for injuries and deaths caused by unsafe products.  It will also prevent the manufacturers of defective devices from receiving total immunity from any claims simply because the devices were previously approved by the Food and Drug Administration (FDA). 

On March 19, 2009, the editors of the New England Journal of Medicine endorsed the Medical Device Safety Act. They stated:

"Patients and physicians deserve to be fully informed about the benefits and risks of medical devices, and the companies making the devices should be held accountable if they fail to achieve this standard. We urge Congress to swiftly pass this legislation and to allow lawsuits by injured patients, which have been an important part of the regulatory framework and very effective in keeping medical devices safe, to proceed in the courts."

The New York Times has also endorsed the bill.

Medical devices can be extremely dangerous, and the FDA often does a poor job screening defective products from the public.  If your doctor wants to insert a medical device into your body, ask questions to be sure your physician has sufficiently investigated the device's safety and effectiveness.

If you think you have been injured by a defective device, we encourage you to read a portion of a book regarding products liability authored by senior partner Salvatore Zambri.

For information about your legal rights, please click here or contact us at Regan Zambri & Long, PLLC at 202-463-3030.

Posted In Medical Malpractice , Medications , Men's Health Issues , Patient Safety , Pediatrics , Product Liability , Public Health , Tort Reform , U.S. Food and Drug Administration Warnings , Women's Health Issues
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FDA Too Lenient On Device Approval

Posted by: Salvatore J. Zambri, Esquire and Catherine Bertram, Esquire

An editorial from yesterday's New York Times challenges the Food and Drug Administration (FDA) , suggesting that the agency has been too lenient in approving medical devices.  The article notes that a “vaginal sling,” used to control urinary leaks, that was previously sold by the Mentor Corporation,  a company that was acquired by Johnson & Johnson, has caused serious medical problems for many women throughout the country. In one instance, a woman's "surgeon inserted a strip of synthetic mesh — Mentor’s ObTape vaginal sling — under her urethra. It stopped the leakage but soon caused pain and bleeding as pieces of the sling worked their way through her vaginal wall. The woman has had five operations to remove bits of the sling, and another is scheduled."

Last year, the FDA received more than 1,000 reports directly from manufacturers about complications with "vaginal-sling"-like devices, according to the report.  About one-fourth of the complaints concerned "ObTape" specifically.  "The injuries may stem from the fact that far too many medical devices are cleared for sale without undergoing rigorous clinical trials for safety and efficacy."

To read the entire article, please click here.

Medical devices can be extremely dangerous, and the FDA often does a poor job screenign defective products from the public.  If your doctor wants to insert a medical device into your body, ask questions to be sure your physician has sufficiently investigated the device's safety and effectiveness.

If you think you have been injured by a defective device, we encourage you to read a portion of a book regarding products liability authored by senior partner Salvatore Zambri.

For information about your legal rights, please click here or contact us at Regan Zambri & Long, PLLC at 202-463-3030.

Posted In Medical Malpractice , Men's Health Issues , Obstetrics , Patient Safety , Pediatrics , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Warning About Insulin Box Mix Ups - Can be Deadly for Patients

By Catherine D. Bertram, Esquire and Salvatore J. Zambri, Esquire

The Institute for Safe Medication Practices (ISMP) issued a warning to health care providers that storing insulin vials inside their cardboard cartons after the packages have been opened can be a medical emergency waiting to happen.

The warning explains, that "if the vial is accidentally returned to the wrong carton after being used, that sets the stage for a serious insulin mix-up.   That is because the next person looking for a particular insulin product could read the label on the carton, assume that it accurately reflects what is inside, and end up administering the wrong product."

ISMP recommends that the cartons be thrown out, either in the pharmacy before the medication is dispensed, or when at the nursing station. The bottom line? Do not dispense or store insulin vials in their cartons on patient care units.

Medication errors by health care providers and hospital personnel can be life threatening.  In most instances these tragic errors should have been prevented.  If you have questions about a medication error that caused permanent injury or contributed to the death of a patient you speak with an experienced medical malpractice attorney about the circumstances or call us (202 463-3030. 

 

Posted In Medications , Patient Safety , U.S. Food and Drug Administration Warnings
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FDA Issues Guidelines for Drug Disposal

By Victor E. Long, Esq.

The FDA has issued guidelines on the disposal of prescription drugs.  The Kaiser Family Foundation states that the average American takes more than 12 prescription drugs annually, with more than 3.8 billion prescriptions purchased each year,

Previously, three federal agencies--the White House Office of National Drug Control Policy, Department of Health and Human Services and Environmental Protection Agency--jointly released new guidelines in February designed to help people safely trash their prescription  drugs.   According to an Enviromental Protection Agency spokesperson  "Flushing medication down the toilet is probably the least desirable of the alternatives," 

Continue Reading Posted In Medications , U.S. Food and Drug Administration Warnings
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FDA Warning: Updated Labeling for Antiepileptic Drugs

In a series of updates, the FDA has now approved updated labeling for antieplietic drugs regarding the suicide risk associated with such drugs. The newest update of May 5, 2009 suggests that all antiepileptic drugs be included in the warning.   We have reproduced the FDA Warnings in their entirety below:

"[UPDATE 05/05/2009] FDA notified healthcare professionals that it approved updated labeling for antiepileptic drugs used to treat epilepsy, psychiatric disorders, and other conditions (e.g., migraine and neuropathic pain syndromes). FDA also required development of a medication guide, to be issued to patients each time the product is dispensed. Since issuing safety alerts on December 16, 2008 and January 31, 2008, FDA has been working with the manufacturers of drugs in this class to better understand the suicidality risk. Eleven antiepileptic drugs were included in a pooled analysis of placebo-controlled clinical studies in which these drugs were used to treat epilepsy as well as psychiatric disorders and other conditions. The increased risk of suicidal thoughts or behavior was generally consistent among the eleven drugs, with varying mechanisms of action and across a range of indications. This observation suggests that the risk applies to all antiepileptic drugs used for any indication.

[UPDATE 12/16/2008] The FDA has completed its analysis of reports of suicidality (suicidal behavior or ideation [thoughts]) from placebo-controlled clinical trials of drugs used to treat epilepsy, psychiatric disorders, and other conditions. Based on the outcome of this review, FDA is requiring that all manufacturers of drugs in this class include a Warning in their labeling and develop a Medication Guide to be provided to patients prescribed these drugs to inform them of the risks of suicidal thoughts or actions.

[Posted 01/31/2008] FDA informed healthcare professionals that the Agency has analyzed reports of suicidality (suicidal behavior or ideation) from placebo-controlled clinical studies of eleven drugs used to treat epilepsy as well as psychiatric disorders, and other conditions. In the FDA's analysis, patients receiving antiepileptic drugs had approximately twice the risk of suicidal behavior or ideation (0.43%) compared to patients receiving placebo (0.22%). The increased risk of suicidal behavior and suicidal ideation was observed as early as one week after starting the antiepileptic drug and continued through 24 weeks. The results were generally consistent among the eleven drugs. The relative risk for suicidality was higher in patients with epilepsy compared to patients who were given one of the drugs in the class for psychiatric or other conditions.

Healthcare professionals should closely monitor all patients currently taking or starting any antiepileptic drug for notable changes in behavior that could indicate the emergence or worsening of suicidal thoughts or behavior or depression.

The drugs included in the analyses include (some of these drugs are also available in generic form):

Carbamazepine (marketed as Carbatrol, Equetro, Tegretol, Tegretol XR)
Felbamate (marketed as Felbatol)
Gabapentin (marketed as Neurontin)
Lamotrigine (marketed as Lamictal)
Levetiracetam (marketed as Keppra)
Oxcarbazepine (marketed as Trileptal)
Pregabalin (marketed as Lyrica)
Tiagabine (marketed as Gabitril)
Topiramate (marketed as Topamax)
Valproate (marketed as Depakote, Depakote ER, Depakene, Depacon)
Zonisamide (marketed as Zonegran)

Although the 11 drugs listed above were the ones included in the analysis, FDA expects that the increased risk of suicidality is shared by all antiepileptic drugs and anticipates that the class labeling changes will be applied broadly.

[December 16, 2008; UPDATED May 05, 2009 - Drug Information Page - FDA]
[January 31, 2008 - Healthcare Professional Information Sheet - FDA]"
 

Posted In U.S. Food and Drug Administration Warnings
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Weight-Loss Products Spiked With Illegal Drugs

Posted by: Salvatore J. Zambri, Esquire and Catherine Bertram, Esquire

The Food and Drug Administration (FDA) has found that more than 70 weight-loss products contain prescription drugs, including four illegal drugs that have not approved by the FDA for sale in the United States, according to Public Citizen, citing its Worst Pills, Best Pills News article released last week on WorstPills.org, the organization’s drug safety website.

The FDA has announced what is obvious--that adding active prescription drug ingredients to otherwise ineffective weight-loss supplements is not only illegal, but can be extremely dangerous.  "For instance, sibutramine (brand name Meridia, an appetite suppressant available by prescription only and a controlled substance) and fluoxetine (brand names Prozac and Serafem, an antidepressant available by prescription only) were among the drugs found in the supplements", states Public Citizen. 

Although the FDA is seeking a voluntary recall of the illegal products, some say the FDA is not acting strong enough.  "The FDA’s response has been inadequate,” said Sidney M. Wolfe, M.D., director of Public Citizen’s Health Research Group and acting Public Citizen president. “Some of the drugs found in these supplements are dangerous and are putting people at an unacceptable risk of injury. To protect citizens, the agency needs to go further and seize these products.”

To read the entire article, please click here.

We encourage our readers to be very careful about what medications they ingest.  All medications should be supervised by a physician.  Don't become a victim of others' greed.

For information about your legal rights, please click here or contact us at Regan Zambri & Long, PLLC at 202-463-3030.

Posted In Medical Malpractice , Men's Health Issues , Patient Safety , Pediatrics , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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FDA Warning: Hydroxycut Products

"FDA warned consumers to immediately stop using Hydroxycut products by Iovate Health Sciences, Inc. Hydroxycut products are associated with a number of serious liver injuries. Hydroxycut products are dietary supplements that are marketed for weight-loss, as fat burners, as energy-enhancers, as low carb diet aids, and for water loss under the Iovate and MuscleTech brand names.


FDA has received 23 reports of serious health problems ranging from jaundice and elevated liver enzymes, an indicator of potential liver injury, to liver damage requiring liver transplant. One death due to liver failure has been reported to FDA. Other health problems reported include seizures; cardiovascular disorders; and rhabdomyolysis, a type of muscle damage that can lead to other serious health problems such as kidney failure.


The agency has not yet determined which ingredients, dosages, or other health-related factors may be associated with risks related to these Hydroxycut products. The FDA continues to investigate the potential relationship between Hydroxycut dietary supplements and liver injury or other potentially serious side effects.


Read the complete MedWatch Safety summary including links to the FDA news release, Q&A's and a listing of all products included in this alert."

Posted In U.S. Food and Drug Administration Warnings
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FDA: 17-year-old to buy Plan B birth control pill without prescription

Posted by Patrick M. Regan

The CBS Evening News (4/22, story 8, 0:20, Couric) reported "an update...on the so-called morning-after birth control pill." On its website, the Food and Drug Administration (FDA) announced on Apr. 22 that "it will obey a judge's order and allow 17-year-olds to buy it without a prescription. The contraceptive, also called Plan B, is taken after unprotected sex and before an egg is fertilized." The FDA's decision, "which overturns one of the most controversial health rulings of the Bush administration, was scorned by abortion opponents and hailed by their abortion rights counterparts."

Continue Reading Posted In Medical Malpractice , Patient Safety , U.S. Food and Drug Administration Warnings , Women's Health Issues
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FDA Recalls 34 Dietary Supplement Products

By Catherine D. Bertram, Esquire and Salvatore J. Zambri, Esquire

The Food and Drug Administration ("FDA ") notified consumers and health care professionals of a recall of 34 dietary supplement products. The FDA lab identified undeclared sibutramine, which is more commonly known as "Meridia",  an FDA-approved drug, used as an appetite suppressant for weight loss. FDA advises that the products listed below pose a threat to consumers because sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke.

Continue Reading Posted In Medications , Patient Safety , U.S. Food and Drug Administration Warnings
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ZOLL AED Defibrillator Recall

Posted by Catherine D. Bertram and Salvatore J. Zambri

The Food and Drug Administration (FDA) issued a Class 1 Recall in April 2009 involving defective Defibrillators that may fail.  This is a Class 1 recall, which is the most serious type of recall and involves situations in which there is a reasonable probability that use of these products will cause serious injury or death.  According to the FDA's recall notice, Zoll Medical Corporation and FDA notified healthcare professionals of a Class 1 recall of ZOLL AED Plus Defibrillators distributed from May, 2004 through February 9, 2009. The recall was initiated because the device may fail to deliver a defibrillation shock, which could result in failure to resuscitate a patient during treatment of sudden cardiac arrest.”

Continue Reading Posted In Patient Safety , U.S. Food and Drug Administration Warnings
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Is the FDA ignoring realities of Internet marketing?

In the New York Times advertising column, Stephanie Clifford writes that "the Food and Drug Administration sent letters to 14 major pharmaceutical companies late last month, "warning them that their "search advertisements...had to start including risk information about each drug or else be rewritten or removed."

The companies, however, argued that "there was no way to include all the required information" within the "95 characters...allowed for search ads." According to Arnie Friede, counsel at McDermott, Will & Emery, "Until these letters were sent, pharmaceutical and media companies had assumed that there was a one-click rule" under which they would be "in compliance" if they "provided risk information within one click of their search ads." In changing the ads, industry executives now claim they "are even more confusing and misleading" and that "the agency is ignoring the realities of Internet marketing." Furthermore, the drug industry argues that the FDA "is not issuing clear rules about compliance."

Posted In Medications , Patient Safety , Product Liability , Public Health , U.S. Food and Drug Administration Warnings
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FDA Obtains An Injuction Against 2 Drug Companies for Distributing Unapproved Medications

By Catherine D. Bertram, Esquire and Salvatore J. Zambri, Esquire

The U.S. Food and Drug Administration announced that it had obtained,  "a permanent injunction barring Neilgen Pharmaceuticals Inc. of Westminster, Md., its parent company, Advent Pharmaceuticals, Inc. (Advent), of East Windsor, N.J., and two of their officers, Bharat Patel and Pragna Patel, from manufacturing and distributing any unapproved, adulterated or misbranded drugs."

Continue Reading Posted In U.S. Food and Drug Administration Warnings
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FDA Warning: Psoriasis Medication Raptiva Withdrawn from Market

On April 8, 2009, Genetech and the US Food & Drug Administration (FDA) announced a voluntary phased withdrawal of Raptiva (efalizumab) from the U.S. market.  We have reproduced the FDA  statement for our readers in its entirety.

FDA Statement

 FOR IMMEDIATE RELEASE
Statement
April 8, 2009

Media Inquiries:
Rita Chappelle, 301-796-4672
Consumer Inquiries:
888-INFO-FDA

FDA Statement on the Voluntary Withdrawal of Raptiva From the U.S. Market

Today, Genentech, the manufacturer of the psoriasis drug Raptiva (efalizumab), announced that it has begun a voluntary, phased withdrawal of the product from the U.S. market. The company is taking this action because of a potential risk to patients of developing progressive multifocal leukoencephalopathy (PML), a rare, serious, progressive neurologic disease caused by a virus that affects the central nervous system. By June 8, 2009, Raptiva will no longer be available in the United States.

Prescribers are being asked not to initiate Raptiva treatment for any new patients. Prescribers should immediately begin discussing with patients currently using Raptiva on how to transition to alternative therapies. The FDA strongly recommends that patients work with their health care professional to transition to other alternative therapies for psoriasis.

The risk that an individual patient taking Raptiva will develop PML is rare and is generally associated with long-term use. Generally, PML occurs in people whose immune systems have been severely weakened and often leads to an irreversible decline in neurologic function and death. There is no known effective treatment for PML. On Oct. 16, 2008, FDA updated the FDA-approved labeling for Raptiva to warn of the risk of life-threatening infections, including PML. On Feb. 19, 2009, the FDA issued a Public Health Advisory informing patients and prescribers of the risk of PML in patients taking Raptiva, after receiving reports of four patients with PML, three of whom died. On March 13, 2009, the FDA approved a Medication Guide for Raptiva and included additional information in Raptiva's labeling regarding PML.

Raptiva was approved by the FDA in 2003. It is a once-weekly injection for adults with moderate to severe plaque psoriasis.

Prescribers should continue to monitor patients on Raptiva for neurologic symptoms that might represent PML. Prescribers and patients may report adverse events to the FDA's MedWatch program at 800-FDA-1088, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or online at www.fda.gov/medwatch/report.htm.

More information about the withdrawal of Raptiva is available on the Genentech Web site: www.gene.com/gene/products. Prescribers with questions about Raptiva may contact Genentech Medical Communications at (800) 821-8590.

Additional Information
Efalizumab (marketed as Raptiva) Information

For information about your legal rights, please click here or call
the law firm of Regan Zambri & Long, PLLC at 202-463-3030.

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FDA Warning: Class 1 Recall of Electronic Infusion Pumps Used for Medications and Fluids

The FDA has issued a Class 1 Recall for electronic infusion pumps that deliver IV medications and fluids to patients.   Class 1 recalls, the most serious category, are made when there is a reasonable probability that use of the product will cause injury or death.  We have reproduced the FDA Warning Notice in its entirety for our readers. 

Class 1 Recall: Baxter Colleague Single and Triple Channel Volumetric Infusion Pumps

Date Recall Initiated: January 23, 2009
Product:  Baxter Colleague Single and Triple Channel Volumetric Infusion Pumps

Model numbers: Mono 2M8151 and 2M8153, CX 2M8161 and 2M8163, and CXE 2M9161and 2M9163

These products were manufactured and distributed from February, 1997 through December, 2008.


Use:  Electronic infusion pumps deliver controlled amounts of medications or other fluids to patients through an intravenous (IV), intra-arterial (IA), epidural, and other acceptable routes of administration.


Recalling Firm:
Baxter Healthcare Corp.
Rt. 120 & Wilson Rd.
Round Lake, Illinois 60073


Reason for Recall:

The company identified software and battery usage failures that result in a delay in or interruption of infusion that may cause serious injury and/or death.


Public Contact:
Customers may call Baxter Healthcare Corp. at 1-800-843-7867


FDA District:
Chicago


FDA Comment:

On January 23, 2009, the company sent a correction letter to all of its customers about failures that could lead to:

* interruption of therapy
* damaged battery messages
* smoke and fire hazards
* serious injury and/or death

The letter also:

* advised institutions to have contingency plans to verify that back-up pumps are available
* provided new steps for addressing an interruption of therapy with any failure code
* provided instructions for addressing damaged battery messages
* provided instructions for proper device cleaning

For more information about this recall, please see the company’s press release at: http://www.baxter.com/about_baxter/news_room/ news_releases/2009/03_11_09_colleague.html

Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the product will cause serious injury or death.

Health care professionals and consumers may report adverse reactions or quality problems experienced with the use of this product to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by FAX.

* Online: www.fda.gov/MedWatch/report.htm
* Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm
Mail to MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787
* FAX: 1-800-FDA-0178

Updated March 11, 2009

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FDA Reevaluates Standards and Rules for Children's Cold Medicine in Response to Mounting Evidence of Hazardous Effects

New FDA-regulated modifications to over the counter cold and cough medicines should be observed by parents of young children. The following is the FDA statement regarding the new regulations applied to over-the-counter cough and cold medicine. Links have been added to the original statement for the readers' convenience.

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FDA Warns Websites: Cease Sales of Fraudulent Cancer Remedies

  According to a report on medicalnewstoday.com, consumer complaints and Internet searches conducted by members of the Mexico-US-Canada Fraud working group lead the Federal Drug Administration (FDA) to find that 125 products sold online, that are boasting prevention, treatment, and/or cures for cancer, are fraudulent. Government officials are concerned that these products will interfere with legitimate cancer treatment and/or be independently harmful to individuals. Furthermore, it is worrisome that cancer patients may rely on these false claims and not seek appropriate medical care.

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FDA Warns Consumers About Two Baltimore Pharmacies

The FDA has issued a warning to consumers regarding expired and suspected counterfeit drugs for two Baltimore pharmacies.   The FDA News Release is reproduced below in its entirety.  

                            FDA News

FOR IMMEDIATE RELEASE
August 8, 2008

Media Inquiries:
Rita Chappelle, 240-753-8603
Consumer Inquiries:
888-INFO-FDA

 

              FDA Warns Consumers About Potential Problems

                                at Two Baltimore Pharmacies

Expired and suspected counterfeit prescription drugs

found at pharmacies

The U.S. Food and Drug Administration is warning consumers who filled prescriptions at The Medicine Shoppe pharmacies located at 8035A Liberty Road and 5900 Reisterstown Road in Baltimore that they may have received drugs that were either expired or suspected counterfeit. The FDA is particularly concerned because a number of the drugs are for serious diseases and could have an adverse effect on treatment.

The products in question include: 

  • Lisinopril (20 milligrams)
  • Guaifenesin/Dextromethorphan (600 mg and 1000 mg)
  • Gabapentin (100 mg, 300 mg and 400 mg)
  • Metoprolol (50 mg)
  • Nifedipine (30 mg)
  • Diclofenac Sodium (30 mg)
  • Glucophage (500 mg Extended Release)
  • Glucovance (125 mg and 500 mg)
  • Glipizide/Metformin (2.50 mg/250 mg)
  • Furosemide (20 mg)
  • Tamoxifen Citrate (10 mg)
  • Metformin HCl ER (500 mg)
  • Calcitrol (0.25 micrograms)

The FDA has no evidence that any other Medicine Shoppe pharmacies outside of the 8035A Liberty Road and 5900 Reisterstown Road facilities are involved.

Because the safety and efficacy of the listed drugs has not been established, the FDA is strongly advising consumers who filled prescriptions for these drugs at these two pharmacies to contact their prescribing physician immediately for new prescriptions. Additionally, consumers in possession of the above listed prescription drugs from these pharmacies should call FDA at 800-521-5783 for further information on how to dispose of the drugs.

Consumers and health care professionals can report adverse events to the FDA's MedWatch program at 800-FDA-1088, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, Md 20852-9787, or online at www.fda.gov/medwatch/report.htm.

 

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FDA Warning: Possible Dangers of CT Scans for Patients with Pacemakers

A recent FDA report to health care providers, warned of potential "adverse events" due to computerized tomography (CT) scans of patients with electronic devices implanted. Though few incidents have been reported thus far, the FDA is taking all reports seriously. Possible adverse events include medical devices shocking patients, sending inaccurate signals due to the CT scans, malfunctions of insulin infusion pumps, and transient changes in pacemaker output pulse rate.

The Chicago Tribune noted this announcement came as a surprise to physicians, many of whom were aware of these dangers with MRI scans. Dr. Leonard Berlin, chairman of the radiology department at Rush North Shore Medical Center in Skokie says he was not aware of this. "We haven't seen any of these problems and I'm not aware of any of my colleagues having seen them either. But, of course, we'll abide by what the FDA is recommending," Dr. Berlin says.

So what devices are possibly affected?

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Guinea-Pigging: Drug Safety Trial Testing for a Living?

Guinea-Pigging, a drug safety-testing method increasingly used by pharmaceuticals, was recently reviewed by bioethicis professor Carl Elliott.  His article discusses the trend of participating in drug trials and testing and making a living off the income.  Professor Elliot cites many concerns regarding "guinea-pigging," which may affect the safety and welfare of the subject as well as the validity of the study.

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Update: Salmonella Investigation Adds Jalapenos, Salsa Fixings

Officials from the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) continue to investigate an ongoing multi-state outbreak of a strain of salmonella known as Salmonella Saintpaul, believed to be linked to the consumption of certain types of raw tomatoes.  The Washington Post reports that investigators are looking at jalapeno peppers and ingredients used to make salsa, such as cilantro and serrano peppers as possible causes of the salmonella outbreak.  Tomatoes will continue to be investigated as well. 
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FDA to Require Boxed Warnings on Older Antipsychotic Drugs

The U.S. Food and Drug Administration (FDA) utilized its new authority this month under the Food and Drug Administration Amendments Act of 2007 (FDAAA) to require manufacturers of older or "conventional" antipsychotic drugs to make safety-related changes to prescription information and labeling.  The required changes are to warn of an increased risk of death linked to the off-label use of these drugs to treat behavioral problems in older people suffering with dementia

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FDA Takes Action to Eliminate Sham Cancer "Cures"

According to the U.S. Food and Drug Administration, 23 U.S. companies and two international manufacturers have been warned to cease their production and marketing of fraudulent cancer remedies.  The agency is also warning consumers not to purchase the products, which include ingredients such as bloodroot, coral calcium, cesium, shark cartilage and Cat's Claw, among others.  Continue Reading Posted In Medications , Patient Safety , Public Health , U.S. Food and Drug Administration Warnings
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Surgery May Leave More Than A Scar

The FDA has recently issued a public heath notification alerting healthcare practitioners of the dangers associated with unretrieved device fragments (UDFs) unintentionally left behind after surgery.  The UDF is a fragment of a medical device, for example, a screw, wire, or broken needle.  Continue Reading Posted In Medical Malpractice , Patient Safety , U.S. Food and Drug Administration Warnings
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Complementary and Alternative Medicine: It's Time to Talk

The National Center for Complementary and Alternative Medicine (NCCAM) -- a division of the National Institutes of Health (NIH), recently launched an educational campaign to encourage patients (particularly those 50 years of age or older) to speak openly with their primary care providers about complementary and alternative medicines.  The campaign, known as Time to Talk, focuses on medical practices and products that aren't presently considered to be conventional medicine -- items such as herbal supplements, meditation and acupuncture.

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Mercury Dental Fillings: Settlement Stirs Concern

The FDA has recently settled a lawsuit with Moms Against Mercury, and has set a deadline of July 28, 2009 for the reclassification of amalgam fillings.  The reclassification would not change the product itself, but it would make the public more aware of the benefits and risks of amalgam dental work and would most likely include a warning label informing the public of the mercury content.

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Hold the Tomatoes: FDA Warns of Salmonella Risk



The Washington Post reports that restaurants are removing tomato slices from sandwiches and grocery stores are purging their produce aisles after a national alert that certain types of raw tomatoes may be responsible for the growing number of people infected with a rare form of salmonella. Continue Reading Posted In Men's Health Issues , U.S. Food and Drug Administration Warnings , Women's Health Issues
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LASIK Eye Surgery: Not For Everyone

According to a recent article in the Washington Post, 7.6 million Americans have undergone elective LASIK eye surgery since the mid-1990s.  LASIK is a surgical procedure intended to reduce a person's dependency on glasses or contact lenses.  LASIK stands for Laser-Assisted In Situ Keratomileusis and is a process that permanently changes the shape of the cornea, the clear covering of the front of the eye.  The surgery involves cutting a small flap in the eye's cornea using a laser.  With the flap held out of the way, the surgeon can then reshape the cornea with another laser to correct nearsightedness, farsightedness, and select cases of astigmatism

While the vast majority benefit -- most see 20-20 or better -- about one in four people who seeks LASIK is not a good candidate.  A small fraction, perhaps 1 percent or less, suffer serious, life changing side-effects, such as: worse vision, severe dry eye, glare, and inability to drive at night. 

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FDA's New System to Track Approved Drugs' Effectiveness

The New York Times reported on the Food and Drug Administration's announcement last week of a new system to track already-released drugs' effectiveness. Called the Sentinel Initiative, many bodies such as the Institute of Medicine have recommended such a system for years. Additionally, the Sentinel Initiative is supported by recently-released research showing fast-tracked approval of new drugs leads to problems down the road. However, there are also many criticisms regarding the system's method of collecting data and its accuracy.

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Heart Surgery Drug Trasylol Confirmed Deadly

A new study has confirmed that hospital patients given Trasylol (aprotinin), a drug used to reduce bleeding during heart surgery, are 53% more likely to die than patients who are given other anti-bleeding drugs.  The drug's manufacturer, Bayer AG, has informed the U.S. Food and Drug Administration (FDA) that it has begun removing all remaining stock of Trasylol from all pharmacies and health care facilities in the U.S.

The latest Trasylol study was released Wednesday is slated to appear in print in the May 29 issue of the New England Journal of Medicine.

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FDA Website: LASIK Surgery Risks and Patient Education

Laser eye surgeries such as LASIK (Laser-Assisted In Situ Keratomileusis) are quickly becoming some of the most common and technologically sophisticated procedures available for correcting relatively minor vision problems.  Generally performed on an out-patient basis with the aid of only anesthetic eye drops, LASIK procedures are usually quick and easy, and the results are often remarkable.  Unfortunately, however, the results can be underwhelming, too -- and occasionally even catastrophic. 

To help clear up some misconceptions and misinformation regarding LASIK procedures, and to help consumers better understand the risks of laser eye surgeries, the U.S. Food and Drug Administration (FDA) has established a web page devoted specifically to patient education.  According to the agency, there are a few categories of people who should think twice before they attempt to resolve their vision problems with LASIK surgery.

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Dietary Supplements Recalled: Toxic Levels of Selenium

The U.S. Food and Drug Administration (FDA) has announced that some flavors of the dietary supplements "Total Body Formula" and "Total Body Mega Formula" have been found to contain dangerously high levels of selenium -- a naturally-occurring mineral that is toxic in high doses.  The sole distributer of the product, Total Body Essential Nutrition, Inc., has issued a voluntary recall. 

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Medical Expert Criticizes FDA Over Dangerous Proposed Relaxation of Prescribing Rules

New U.S. Food and Drug Administration (FDA) guidelines for oversight of "off-label" drug use -- still in draft form and unfinalized -- could allow pharmaceutical companies to market more drugs for unapproved uses.  The proposed guidelines are a step in the wrong direction according to Dr. Randall Stafford, an associate professor of medicine at the Stanford Prevention Research Center.  His concern for patient safety was articulated in a recent edition of the New England Journal of Medicine.

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Early Communication From FDA Regarding Potential Singulair Reactions

The U.S. Food and Drug Administration (FDA) has announced that it is working with Merck, Inc., the pharmaceutical company, to explore a possible link between the popular asthma and allergy drug Singulair (known generically as montelukast) and behavioral changes, mood changes, and increased rates of suicide among users.  The investigation could take nine months, and although the agency is not yet recommending that anyone stop taking the drug, it is asking health care professionals to monitor Singulair patients for changes in condition that may indicate a suicide risk.

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Neupro: Transdermal Patch for Early Parkinson's Disease Recalled

Neupro (rotigotine), the first skin patch approved to treat symptoms of Parkinson's disease in the U.S. in 2007, is being recalled by the FDA.   Physicians have been advised to not start  new patients on the transdermal patch and to begin tapering down patients who are currently using the patch.  After the end of April, Neupro will not be available in the United States.   Neupro is being recalled because of formation of rotigotine crystals that can form on the patches, thus altering the amount of medication that can be absorbed through the skin.  

For further details, please call the company's toll-free information number: 800-477-7877.

Please contact your doctor for further advice regarding Neupro's recall.

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If You Must Express Yourself with Body Art, at Least Follow Safety Precautions Offered by FDA and AMA

Body art (including practices like tattooing and piercing) is a popular form of self-expression.  These permanent markings are typically created by professional artists, but the health and safety regulations they must follow vary according to the city, county or state regulations under which they practice.   Furthermore, certain aspects of body art, such as tattooing, entail unavoidable health risks, such as exposure to inks and dyes that have never been approved by the U.S. Food and Drug Administration (FDA) for use on human skin.  Some of those inks have also been known to react badly when exposed to diagnostic magnetic resonance imaging (MRI) scans. Continue Reading Posted In Patient Safety , Public Health , U.S. Food and Drug Administration Warnings
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Spiriva May Contribute to Stroke Risk: FDA Warning

Spiriva, a pulmonary drug marketed by Pfizer and Boehringer Ingelheim Pharmaceutical, appears to increase the risk of stroke, according to a public warning from the the  U.S. Food and Drug Administration (FDA).  Though a comprehensive assessment of the drug's safety is not yet complete, a potential for adverse events has prompted the agency to issue a warning, to assist patients and physicians in identifying any potential problems immediately.

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Baxter Healthcare Corp. Recalls All Remaining Heparin Vials and Hep-Lock Products

According to the U.S. Food and Drug Administration (FDA), Baxter Healthcare Corp. has announced that it is recalling all remaining multi-dose vials of their heparin, as well as single-dose vials and Hep-Lock heparin flush products, which prevent blood clots in intravenous (IV) lines.  Baxter widened its initial recall after another manufacturer of multi-dose heparin vials -- APP Pharmaceuticals of Schaumburg, Ill. -- was able to assure the FDA that it could meet the demand for the entire supply of the blood thinner in the United States.  Several U.S. manufacturers produce items similar to Baxter's Hep-Lock.

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Some Dietary Supplements Contain Hormonal Components that May Promote Prostate Cancer: New Study

Some over-the-counter dietary supplements have been found to contain hormonal ingredients that speed up the development of colon cancer and also make important cancer-treating drugs less effective.  The finding is the result of recent research conducted at the University of Texas Southwestern Medical Center and published in a recent edition of Clinical Cancer Research.

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FDA Announces Recall of Icy Hot Therapy Patches

Many over-the-counter Icy Hot therapy products have been voluntarily recalled by Chattem, Inc., according to a recent announcement by the U.S. Food and Drug Administration (FDA).  According to the agency, customers suffered first, second and third degree burns, skin irritation and skin removal due to their use of the Icy Hot Heat Therapy Air Activated Heat patch.

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Botox Linked to Respiratory Failure and Death: FDA Warning

The U.S. Food and Drug Administration (FDA) is warning that three products:  Botox, Botox Cosmetic (Botulinum toxin Type A), and Myobloc (Botulinum toxin Type B) have been linked to fatal adverse reactions including respiratory failure.  The most severe adverse reactions have occurred in children with cerebral palsy, who rely on the drug for treatment of limb spasticity.  The FDA warns that it has not approved any Botulinum toxins for treatment of spasticity in either children or adults, though it is not advising healthcare professionals to stop prescribing the products at this time. 

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Thousands of Pediatric ER Visits Linked to Cough and Cold Medications Each Year: New Study

Each year more than 7,000 children 11 years of age or younger visit hospital emergency rooms due to incidents involving over-the-counter cough and cold medications.  Two-thirds of those incidents involve kids taking the medications without adult supervision.  The findings are the result of recent research published in the journal Pediatrics, the official journal of the American Academy of Pediatrics.

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FDA Health Advisory: Don't Use ANY Over-the-Counter Cough and Cold Medicine for Children Under 2 Years of Age

The FDA recently announced that no OTC cough and cold products are safe for children under the age of two years.   Studies are on-going for children between the ages of two and eleven.   The FDA announcement is reproduced in its entirety below. 
Public Health Advisory
Nonprescription Cough and Cold Medicine Use in Children
FDA Recommends that Over-the-Counter (OTC) Cough and Cold Productsnot be used for Infants and Children under 2 Years of Age


"FDA has completed its review of information about the safety of over-the-counter (OTC) cough and cold medicines in infants and children under 2 years of age.  FDA is recommending that these drugs not be used to treat infants and children under 2 years of age because serious and potentially life-threatening side effects can occur.

FDA’s recommendation is based on both the review of the information we received about serious side effects in children and the discussion and recommendations made at the October 18–19, 2007, public advisory committee meeting at which this issue was discussed.  FDA strongly supports the actions taken by many pharmaceutical manufacturers to voluntarily withdraw cough and cold medicines that were being sold for use in this age group. 

FDA has not completed its review of information about the safety of OTC cough and cold medicines in children 2 through 11 years of age.  We are aware of reports of serious side effects from cough and cold medicines in children 2 years of age and older.  FDA is committed to completing its comprehensive and thorough review of the safety of OTC cough and cold medicines in children 2 years of age and older as quickly as possible and expects to communicate our recommendations to the public in the near future. 

Pending completion of FDA’s ongoing review, if parents and caregivers use OTC cough and cold medicines in children 2 years of age and older, FDA recommends:

  • Checking the “active ingredients” section of the DRUG FACTS label.  This will help you understand what “active ingredients” are in the medicine and what symptoms each active ingredient is intended to treat. Cough and cold medicines often have more than one “active ingredient” (such as an antihistamine, a decongestant, a cough suppressant, an expectorant, or a pain reliever/fever reducer).

  • Being very careful if you are giving more than one OTC cough and cold medicine to a child.  Many OTC cough and cold medicines have more than one “active ingredient.”  If you use two medicines that have the same or similar “active ingredients” a child could get too much of an ingredient which may hurt your child. For example, do not give a child more than one medicine that has an antihistamine.

  • Carefully following the directions in the DRUG FACTS part of the label.  These directions tell you how much medicine to give and how often you can give it.
  • Only using the measuring spoons or cups that come with the medicine or those made specially for measuring drugs. Do not use common household spoons to measure medicines for children since household spoons come in different sizes and are not meant for measuring medicines.

  • Choosing OTC cough and cold medicines with childproof safety caps, when available, and store the medicines out of the reach of children.

  • Understanding that using OTC cough and cold medicines are intended only to treat your child’s symptom(s).  OTC cough and cold medicines do not treat the cause of the symptoms or shorten the length of time your child is sick.  They only relieve symptoms and make your child feel more comfortable.

  • Not using these products to sedate your child or make children sleepy.

  • Calling a physician, pharmacist, or other healthcare professional if you have any questions about using cough or cold medicines in children 2 years of age and older. "
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Hib Vaccine Recalled, Shortage Looming

Merck & Co., Inc. has announced a voluntary recall of two of its Haemophilus influenza type b (Hib) vaccines, PedvaxHIB® (monovalent Hib vaccine) and COMVAX® (Hib/hepatitis B vaccine), and won't resume distribution until the fourth quarter of 2008.  The U.S. Centers for Disease Control (CDC) is warning that as a result, pharmaceutical manufacturers likely will not be able to provide adequate Hib vaccine to inoculate all children for whom the vaccine is recommended during the following year.

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Medical Schools Influence the Way Physicians Interact with Drug Companies: New Study

Pharmaceutical companies spend an average of $21 billion per year advertising prescription drugs, and most of that is directed at physicians, physicians-in-training and medical students.  Whether medical schools facilitate or discourage their students' exposure to pharmaceutical advertising significantly impacts the way physicians will later view drug companies, according to a new study published in the Journal Pediatrics, the official journal of the American Academy of Pediatrics (AAP). Continue Reading Posted In Medical Malpractice , Medications , Patient Safety , Public Health , U.S. Food and Drug Administration Warnings
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Cardiologists Concerned Over Unexplained Two-Year Delay in Drug Study Results

Cardiologists are growing increasingly suspicious over the hesitation of drug makers to release the results of clinical trials for the cholesterol-lowering drugs Vytorin and Zetia, according to a recent New York Times article.  The two drugs are prescribed for an estimated 800,000 Americans every week, generating sales of $4 billion in 2007 alone.  Clinical trials of the drugs ended two years ago, but manufacturers Merck and Schering-Plough have yet to release those research results.

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Tamiflu & Relenza: FDA Experts Recommend New Label Warnings for Children's Flu Medications

According to a safety review by FDA experts, the flu drugs Tamiflu and Relenza should carry a package warning label about possible dangerous psychiatric side effects in children. Tamiflu was approved by the FDA for pediatric use for children under 12 in 2005.  

Safety concerns became evident two years ago after Japanese reports of 25 deaths and 32 incidents of psychiatric problems in children after taking Tamiflu.  Following reports of children experiencing "neuropsychiatric events," to include delirium, delusions, hallucinations, impulsive behavior and self-injury, new studies of the drug were initiated. Tamiflu is available in pill and syrup form, and is used to treat symptoms of seasonal influenza. 

On Tuesday, November 27, 2007, the FDA's Pediatric Advisory Panel will review the data and determine whether to issue new warning labels for Tamiflu and Relenza.  According to the FDA documents, the problems usually occur within 24 hours of first taking the medication, and usually among patients younger than 21.  FDA documents indicate, "In the remaining reports of delirium with impulsive behavior and self-injury, patients were attempting to flee or escape from windows or balconies and were unsuccessful in their efforts. In addition, there were a few patients who became aggressive or violent and/or performed acts that were injurious to themselves (e.g. banging head against wall) or others (e.g. child tried to strangle mother)."

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FDA Seizes Cosmetic Eye Product Over Eye Injury Concerns

At the request of the U.S. Food and Drug Administration (FDA), U.S. Marshals recently seized  more than 12,000 tubes of cosmetic eyelash product worth approximately $2 million, because the product contained undeclared bimatoprost -- a prescription drug ingredient used in the treatment of increased eye pressure. Continue Reading Posted In Medications , Product Liability , U.S. Food and Drug Administration Warnings
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Traysol Heart Surgery Drug: FDA Announces Suspension of Marketing Until Review Completed

Bayer Schering Pharma, the manufacturer of popular heart surgery drug Trasylol, will suspend all marketing of the drug until a review can be conducted of recent Canadian research which has implicated the drug in a higher risk of death for cardiac patients. 

Continue Reading Posted In Medical Malpractice , Medications , Men's Health Issues , Patient Safety , Product Liability , U.S. Food and Drug Administration Warnings , Women's Health Issues
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FDA Issues Warning Update on "Stay-Awake" Drug, Provigil

The U.S. Food and Drug Administration (FDA) and pharmaceutical manufacturer, Cephalon, have notified physicians of a change to the warning which accompanies Provigil -- a drug used in the treatment of narcolepsy and obstructive sleep apnea.  The drug has recently been linked to life-threatening skin infections and other serious hypersensitivity reactions, as well as to adverse psychiatric symptoms, such as anxiety, mania, hallucinations, and suicidal ideation. 

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Dietary Supplement Safety Tips: Natural and Herbal Labels Don't Guarantee Safety

U.S. Marshals recently seized $71,000 worth of dietary supplements at the request of the U.S. Food and Drug Administration (FDA).  The supplements, marketed and distributed by FulLife Natural Options, Inc., of Boca Raton, Florida, had been promoted for the treatment of diabetes, anemia and hypertension, but had never been approved by the FDA, making them unapproved new drugs.  The agency moved to have the supplements seized by federal agents after conducting multiple investigations of FulLife's business practices and issuing warnings regarding the unproven health claims.

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New Ear Infection "Superbug" Resists All Pediatric Antibiotics

A strain of bacteria responsible for ear infections in children has been discovered to be resistant to all eighteen antibiotics approved for pediatric use, according to a recent article in the Journal of the American Medical Association.  Pediatricians discovered the strain by performing a procedure known as tympanocentesis (or an "ear tap"), and analyzing the fluid.  The strain, known by scientists as 19A, can be eradicated only with levofloxacin, an antibiotic approved for use in adults, but which specifically carries a warning against use in children. Continue Reading Posted In Medications , Patient Safety , Pediatrics , Public Health , U.S. Food and Drug Administration Warnings
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FDA Links Heart Imaging Drugs to Serious Risks, Fatalities

The U.S. Food and Drug Administration (FDA) has warned that a type of drug used in heart testing can cause serious cardiopulmonary reactions, and has advised that a Black Box warning should warn against the risk.  Marketed as Definity and Optison, the drugs, classified as micro-bubble ultrasound contrast agents, are used by physicians to get a clearer image of the heart during electrocardiography.  The FDA has warned that these drugs have caused as many as 11 deaths and nearly 200 dangerous adverse reactions, mainly in patients with severe heart conditions.  Adverse reactions typically occur between 1 and 12 hours after administration of the injectable drug.

Continue Reading Posted In Medications , Men's Health Issues , Patient Safety , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Pediatric Cold Remedies Removed From Market Over Safety Concerns

More than a dozen children's cough and cold medications have been voluntarily recalled by their manufacturers this week in response to mounting safety concerns, according to a Washington Post report.  Fourteen branded, over-the-counter (OTC) cold remedies marketed for use in children under 2 years of age have been pulled from store shelves so far.  The popular drugs have never been approved by the United States Food and Drug Administration (FDA) for use in children. Continue Reading Posted In Medications , Patient Safety , Pediatrics , U.S. Food and Drug Administration Warnings
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FDA Issues Advisory on Fentora Following Overdoses, Deaths

Fentora, a cancer pain medication, is too frequently misused and improperly prescribed, according to a Public Health Advisory recently issued by the U.S. Food and Drug Administration (FDA).  Manufactured by Cephalon, Inc., Fentora is most commonly prescribed to treat breakthrough pain in terminal cancer patients who have already developed a tolerance to opioid pain medications.  According to the FDA, Fentora-associated deaths have recently occurred in non-cancer patients, and in patients who lacked opioid tolerance, indicating that the drug has been prescribed incorrectly.  Some patients have suffered adverse reactions following a dosage of Fentora that was too high, and some adverse events have occurred after patients took too many doses of the drug.

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FDA Cautions Abbott Blood Glucose Meter Users

FDA Medwatch recently reported that some models of the Abbott blood glucose meters that may have been dropped may result in inaccurate or unreadable results.   Patients should perform a meter display check  as instructed in the meter's User Guide.  

Following is the complete MedWatch notification:

"MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Abbott notified users of Precision Xtra, Optium, ReliOn Ultima, Rite Aid, and Kroger blood glucose meters (manufactured after January 31, 2007), to check display screen of the meter to make sure that it is working properly. If meters are dropped onto a hard surface, part of the display can be jarred or disconnected, thereby making it difficult to read the lot number or date information. Additionally, dropping the meter can cause the screen to appear blank, which could result in an inability to view blood glucose test results. The inability to generate blood glucose results may cause a significant risk for hypoglycemia or hyperglycemia.

Users of these meters who note that the display screen is not working properly should immediately stop using their meter. Patients should keep their glucose meters in the wallet provided to offer additional protection for the meter. If the meter is dropped on a hard surface, patients should immediately perform a meter display check. Instructions on how to do this are detailed in the meter's Users Guide. If no problems are encountered during the automatic display check, the meter is ready for use.

Read the complete MedWatch 2007 Safety Summary including a link to Abbott's Press Release at:
http://www.fda.gov/medwatch/safety/2007/safety07.htm#Glucose

To send a comment or question to the MedWatch program: http://www.fda.gov/medwatch/feedback.htm"

Posted In U.S. Food and Drug Administration Warnings
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FDA to Scrutinize Children's Cold Medicine

The U.S. Food and Drug Administration (FDA) has warned that children's cold medicines can be deadly if over-used.  According to a recent Public Health Advisory,  serious adverse events recently reported in conjunction with the use of many common, over-the-counter cold remedies appear to be the result of over-medication.  The agency has announced that its Nonprescription Drugs Advisory Committee will meet to discuss the safety and effectiveness of these drugs in October.  In the interim, the agency recommends that parents who administer over-the-counter cold remedies to their children adhere to the following safety guidelines:

Continue Reading Posted In Medications , Patient Safety , Pediatrics , U.S. Food and Drug Administration Warnings
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Nursing Mothers Should Use Codeine with Caution: FDA Warning

Women who are ultra-rapid metabolizers of codeine may inadvertently expose their babies to lethal levels of morphine if they take the drug while breastfeeding.  At least one infant has recently died from a morphine overdose linked to contaminated breast milk -- the mother had been taking codeine for episiotomy pain.  The U.S. Food and Drug Administration (FDA) recently issued a warning related to the potential dangers of the drug for nursing mothers and babies. Continue Reading Posted In Medical Malpractice , Medications , Obstetrics , Patient Safety , Pediatrics , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Growth Hormone Ineffective, Dangerous As Anti-aging Therapy: New Study

Human growth hormone is ineffective at slowing the aging process and may be dangerous, according to a report published earlier this year in the journal Annals of Internal Medicine.  The hormone has been advertised as a revolutionary anti-aging therapy. Initial studies regarding its effectiveness as such seemed to show that it was effective at improving bone density, cholesterol levels and body composition in older adults.  This latest research disproves those claims, however.  Authors of the study are quick to remind that the U.S. Food and Drug Administration has never approved growth hormone for this purpose, and prescribing it as an anti-aging remedy is illegal. Continue Reading Posted In Men's Health Issues , U.S. Food and Drug Administration Warnings , Women's Health Issues
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FDA: Antipsychotic Drug Approved for Children, But Critics Disagree

The U.S. Food and Drug Administration (FDA) recently announced its approval of the antipsychotic drug Risperidone (marketed as Risperdal) for the treatment of schizophrenia in adolescents between 13 and 17 years of age, and for the treatment of bipolar I disorder in children and adolescents between the ages of 10 and 17.  It is the first atypical psychiatric drug ever approved to treat these disorders in children, and at least one human interest organization is concerned that the drug's approval came too easily.

Continue Reading Posted In Medications , Patient Safety , Pediatrics , Public Health , U.S. Food and Drug Administration Warnings
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FDA Re-Approves Zelnorm for Limited Use

Zelnorm (tegaserod maleate), a constipation drug removed from the market earlier this year by the U.S. Food and Drug Administration (FDA) will be made available once again under restricted access guidelines.  Patients and physicians who were left with no alternative treatment options following the agency's ban had appealed to the FDA earlier this year, requesting that it reconsider its position.  The agency banned the marketing and sale of the drug in the U.S. after it was associated with an unacceptably high risk of heart attack, stroke and unstable angina in patients.
Continue Reading Posted In Medications , Patient Safety , U.S. Food and Drug Administration Warnings
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FDA Adds Black Box Warning to Actos, Avandia

The U.S. Food and Drug Administration (FDA) has announced that a black box warning has been placed on the popular diabetes drugs Avandia and Actos (pioglitazone hydrochloride), regarding an increased risk of heart failure among some patients taking the medications.  The drugs treat Type 2 diabetes by decreasing insulin resistance. The warnings will be aimed at physicians who prescribe the drugs, urging them to monitor their patients for dangerous cardiac symptoms.  The drugs had previously been labeled as increasing the risk of heart failure, but a stronger warning label was agreed upon when it became evident that physicians were still prescribing the drug too frequently. 

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54 Prescription Drugs Get Safety Label Updates

Safety labels on fifty-four prescription drugs have recently undergone changes that may merit your attention, according to the U.S. Food and Drug Administration (FDA).  Flagged as part of the agency's Safety Information and Adverse Event Reporting Program, the latest labeling changes could alert many patients to health hazards or dangerous situations before they become critical.  The following drugs made changes to the "contraindications" or "warnings" sections of their labeling: Continue Reading Posted In Medications , U.S. Food and Drug Administration Warnings
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Guidant Heart Defibrillator Cases Settled by Boston Scientific

Guidant Heart Defibrillator manufacturer, Boston Scientific, settled about 4,000 patient lawsuits this week for $195 million, according to the New York Times.  Those patients claimed that the corporation neglected to inform them of potential flaws in the heart device -- at least seven people died following malfunctions caused by faulty insulation.  Though Guidant (which was bought by Boston Scientific in 2006), knew that the defibrillators were dangerous, they didn't acknowledge it publicly until 2005, and continued selling the defective products in the interim.  In total, more than 100,000 devices were eventually recalled.  Guidant had held far more than the settlement amount in reserve explicitly to settle lawsuits related to the defibrillator defects.

Previously on the D.C. Metro Area Medical Malpractice Law Blog, we posted an article regarding an earlier Guidant Fraud Settlement.

If you or a family member believes that you have a case involving a defective medical device, please contact us on-line at Regan Zambri & Long or call us at 202-463-3030 for a free consultation.  If you would like to receive our complimentary electronic newsletter, please click here. Posted In Patient Safety , U.S. Food and Drug Administration Warnings
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Some Red Yeast Rice Products Contain Undeclared Prescription Drugs: FDA Warning

Red yeast rice and red yeast rice supplements are often marketed as cholesterol-lowering alternatives to medication.  The U.S. Food and Drug Administration (FDA) has announced, however, that some red yeast rice products may lower peoples' cholesterol because manufacturers have been illegally lacing them with lovastatin -- the active ingredient in Mevacor, a prescription cholesterol drug.  The FDA has issued warnings related to the following specific red yeast rice products:

  • Red Yeast Rice and Red Yeast Rice/Policosonal Complex, sold by Swanson Healthcare Products, Inc. and manufactured by Nature’s Value Inc. and Kabco Inc., respectively
  • Cholestrix, sold by Sunburst Biorganics.
Continue Reading Posted In Medications , Men's Health Issues , Patient Safety , Product Liability , Public Health , U.S. Food and Drug Administration Warnings
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Federal Jury Awards $5.5 Million in Damages in Duragesic Patch Case

A federal jury in Florida has awarded $5.5 million to the estate of a 28-year-old man who died of an accidental overdose of pain medication because his Duragesic narcotic patches were defective.  The single-use patches which deliver fentanyl, a narcotic, via skin absorption, are manufactured by two Johnson & Johnson subsidiaries.  A jury found the manufacturers guilty of negligence in the manufacture of the patch, and of failing to adequately warn people about its dangers. 

Continue Reading Posted In Medications , Patient Safety , Product Liability , U.S. Food and Drug Administration Warnings
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Whole Foods Market Recalls Chocolate Bars Over Undeclared Nuts

Whole Foods Market has issued a recall of Swiss Dark Chocolate Bars marketed under the 365 Organic Everyday Value label, because they could contain undeclared almonds.  The chocolate bars were sold in stores throughout the U.S., including Maryland, Virginia and the District of Columbia.  According to the U.S. Food and Drug Administration (FDA), the bars affected by the recall have a lot code that begins with the letters "L71423" followed by a time stamp of between the hours of 11:33 and 12:15.  The time stamp can be found on the back of the wrapper.  The recall is only being conducted because the product ingredient label does not include almonds -- a flaw that has been tied to a temporary error in the packaging process.  Customers who purchased the chocolate bars can return them to the store for a full refund, or may call Whole Foods Markets at (512) 542-0656.  According to the Nemours Foundation, sponsor of the popular Kids' Health Organization, some of the earliest signs or symptoms that you're experiencing a nut allergy may include:

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Expanded Castleberry's Recall Includes Exploding Cans of Botulism-Infected Food

A previous recall of Castleberry's Food Company products contaminated with deadly Clostridium botulinum has been expanded significantly to include more than 90 items according to the U.S. Food and Drug Administration.  Many contaminated canned goods are beginning to swell and explode as a result of the bacterial growth.  According to the U.S. Centers for Disease Control (CDC), consumers must be especially careful in handling and disposing of these infected products, preventing any kind of human exposure to their contents.  The agency's website provides the following advice regarding proper disposal:

 

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Castleberry's Canned Foods Recalled Over Botulism Concerns

Several canned products from Castleberry's Food Company may be contaminated with Botulism, and are being voluntarily recalled, according to the U.S. Food and Drug Administration (FDA).  Following is a list of affected products:
  • Castleberry's Hot Dog Chili Sauce, 10 oz can (UPC 3030000101)
  • Austex Hot Dog Chili Sauce, 10 oz can (UPC 3030099533)
  • Kroger Hot Dog Chili Sauce, 10 oz can (UPC 1111083942)
  • Morton House Corned Beef Hash, 15 oz can (UPC 7526665830)
  • Cattle Drive Chili with Beans, 15 oz can (UPC 3030001515)
  • Southern Home Corned Beef Hash, 15 oz can (UPC 0788015360)
  • Meijer Corned Beef Hash, 15 oz can (UPC 4125095229)
  • Castleberry's Chili with Beans, 15 oz can (UPC 3030001015)
  • Castleberry's Barbecue Pork, 10 oz can (UPC 3030000402)
  • Bunker Hill Chili No Beans, 10 oz can (UPC 7526604112)
Continue Reading Posted In Public Health , U.S. Food and Drug Administration Warnings
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Bayer Ascensia Blood Glucose Monitors Recalled

The Bayer Ascensia Contour Blood Glucose Monitoring System, Product 7152A, has been recalled by Bayer Healthcare and the U.S. Food and Drug Administration (FDA).  The reason for the recall is that the numeric display reports the wrong units of measure for Canadian users.  According to the recall notice, though the monitors should display results in mmol / L format, they are instead calibrated to display in mg / dL format -- a mistake that could easily lead to mis-management of blood sugar levels, potentially causing hypoglycemia. 

Patients with questions regarding the recall are instructed to call Bayer Healthcare at 1-574-256-3441.

For information about your legal rights, please click here or call the law firm of Regan Zambri & Long, PLLC at 202-463-3030. Posted In Patient Safety , U.S. Food and Drug Administration Warnings
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Detox Diets: Medical, Nutrition Experts Urge Caution

With names like The Mediterranean Diet and The Lemonade Diet among others, "detox diets" -- and their celebrity devotees -- enjoy significant media attention.  Medical and nutrition experts urge caution, however, and advise that detox diets can be particularly dangerous for teens, who need calories and nutrients to support their growth, and for those with diabetes, whose blood glucose levels should remain constant and stable.
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Drug Companies Still Romancing Physicians: New Evidence

Two medical journals this spring have reported that pharmaceutical companies continue to make questionable payments to physicians as incentives to boost drug sales. 
Continue Reading Posted In Medications , Patient Safety , U.S. Food and Drug Administration Warnings
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Drugs with the Same or Similar Names Pose Dangers: FDA Advisory

Drugs with identical brand names may contain completely different chemicals -- and treat completely different illnesses -- depending on the country in which they are sold, according to the U.S. Food and Drug Administration (FDA).  The FDA has issued an advisory that although a registry of drug names is maintained in the U.S., and proposed new drug names are compared against it, no organization provides such a safeguard internationally.  As a result, drugs like Flomax, if bought from a U.S. pharmacy, will always treat an enlarged prostate.  Buy Flomax at a pharmacy in Italy, however, and you'll get a pain reliever. 

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Trader Joe's Onions Recalled: Listeria Contamination

Ten-ounce bags of Trader Joe's brand diced onions could be contaminated with Listeria monocytogenes, the U.S. Food and Drug Administration has warned.  Gills Onions, LLC is recalling the diced yellow onions after government inspectors detected the organism during a routine inspection.  No illnesses have yet been associated with the onions.   It is thought that shipments of the infected onions were limited to the states of Arizona, California, Nevada, New Mexico, Oregon and Washington.  Continue Reading Posted In Public Health , U.S. Food and Drug Administration Warnings
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FDA: Absent for Many Drug Committee Hearings

Public Citizen, a non-profit public interest organization, has petitioned the U.S. Food and Drug Administration (FDA) to give oral presentations at all advisory committee meetings that involve the presentation of specific products.  According to a recent article published in The Lancet, of the 275 public meetings of the FDA's Human Drug Advisory Committee occurring between 1997 and 2006, 49 included no oral scientific presentation by the agency.  In contrast, drug company representatives made presentations at every meeting but one. 

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FDA Issues New Rule for Dietary Supplements

The U.S. Food and Drug Administration (FDA) has issued a final rule for current good manufacturing processes (CGMPs) for dietary supplements.  The new rule is aimed at ensuring that supplements are free of undeclared active ingredients and impurities.  According to the FDA, if a supplement is now found by inspectors to not contain the exact ingredients claimed by its manufacturer, the agency could officially deem the product adulterated or misbranded, and compel the producer to change its labeling or remove an ingredient.  Alternatively, the agency could seize the product and file a lawsuit, or seek criminal charges against its manufacturer.  The dietary supplement industry has historically faced little regulation.  Some critics maintain that even this new rule doesn't go far enough to protect consumer safety.

For information about your legal rights, please click here or call the law firm of Regan Zambri & Long, PLLC at 202-463-3030.  

Posted In Medications , Men's Health Issues , Patient Safety , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Anti-psychotics Unsafe for Elderly with Dementia: New Study

Anti-psychotic drugs can be fatal for some elderly patients, according to a new study published in the Annals of Internal Medicine.  The study included more than 27,000 patients over age 66 who suffered from dementia, and revealed that the use of the drugs in these patients contributes to an increased risk of death. 

An advisory issued by the FDA in 2005 warned that patients who suffered from dementia and who also took atypical anti-psychotics such as Zyprexa, Seroquel, Risperdal, suffered a rate of death 1.6 to 1.7 times higher than similar patients who only took a placebo.  Most of those deaths seemed to be heart-related or linked to infections.  The FDA subsequently requested that manufacturers label these anti-psychotic drugs with appropriate warnings and note that they were not approved for the behavioral treatment of elderly patients with dementia.  Many physicians continue to prescribe them, however.  This new study lends more scientific weight to the idea that these drugs are not appropriate for many elderly patients.  The FDA advises that elderly patients taking the drugs for behavioral reasons should have their treatment plans reviewed by health care professionals. 

The Alzheimer’s Association, a nonprofit voluntary organization addressing Alzheimer’s Disease, notes that the range of appropriate behavioral treatments for dementia consists of both non-drug interventions and prescription medications, and the organization recommends that non-drug interventions be tried first.  The group has also designed the internet-based “Alzheimer’s Association Care Finder,” an interactive guide to educate consumers about recognizing quality Alzheimer’s care, choosing the best care options, and advocating for quality care in residential facilities. 

Posted In Medications , U.S. Food and Drug Administration Warnings
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Fake "Colgate" Toothpaste Recalled

Discount store toothpaste labeled "Colgate" and sold in 5-ounce tubes is being recalled after it was found to contain diethylene glycol, an ingredient used to make anti-freeze, according to a bulletin issued by the U.S. Food and Drug Administration (FDA).  The product was also found not to contain fluoride. 

The Colgate-Palmolive company denies responsibility for the contamination, noting that the affected toothpaste is counterfeit and that the boxes are marked "Manufactured in South Africa," and feature a number of misspelled words.  Colgate does not import its product from South Africa, and is working closely with the FDA to identify the source of the contaminated product. 

If you suspect you have purchased counterfeit Colgate toothpaste, you are urged to call the Colgate-Palmolive at (800) 468-6502.

If you or a family member believes that you have a case involving a dangerous product, please contact us on-line at Regan Zambri & Long or call us at 202-463-3030 for a free consultation.  If you would like to receive our complimentary electronic newsletter, please click here. 

Posted In Patient Safety , Product Liability , Public Health , U.S. Food and Drug Administration Warnings
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Organ, Tissue Harvesting Industry Safe, According to FDA Report

The FDA has reported that there are no significant problems in the nation's organ harvesting industry.  The report comes less than a year after the formation of the Human Tissue Task Force, a group charged with evaluating the effectiveness of the agency's tissue regulations. 

Over a period of six months, beginning last October, agents from the FDA's Office of Regulatory Affairs (ORA) inspected 153 major tissue recovery businesses, finding no major inaccuracies or deficiencies that would jeopardize the public health. 

Safety problems in the industry have been exposed by a series of recent scandals, the largest involving Biomedical Tissue Services of New Jersey.  The operator of that company has been charged with stealing corpses and unlawfully dissecting them to sell organs.  Many funeral home directors have already plead guilty to crimes involving the company. 

All recent organ harvesting scandals have involved businesses which lacked accreditation by the American Association of Tissue Banks, an organization that imposes more stringent safety standards than the FDA requires.  Membership in the organization is strictly voluntary, however.  The FDA requires no accreditation of tissue handling businesses.

We have posted articles about the lax inspection of transplant organs previously on the DC Metro Medical Malpractice Blog.

If you or a family member believe that you have a case involving inappropriate organ transplantation or medical malpractice, please contact us on-line at Regan Zambri & Long or call us at 202-463-3030 for a free consultation.  If you would like to receive our complimentary electronic newsletter, please click here. Posted In Patient Safety , Public Health , U.S. Food and Drug Administration Warnings
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Similac Special Care Premature Infant Formula Recall: Insufficient Iron Contents

According to MedWatch - The FDA Safety Information and Adverse Event Reporting Program, Similac Special Care 24 Cal/fl.oz Ready to Feed Premature Infant Formula With Iron has been recalled because the product contains less iron than is stated on the label.  The following alert was distributed by MedWatch on May 29, 2007. 

"Abbott informed consumers and healthcare professionals of a nationwide recall of three lots of two-ounce bottles of Similac Special Care 24 Cal/fl. oz. Ready-to-Feed Premature Infant Formula with Iron, a highly specialized liquid ready-to-feed formula used only for premature infants after discharge from the hospital.  The three lots of formula were recalled because they do not contain as much iron as indicated on the label.  The formula was distributed in the United States between November 2006 and May 2007.  Premature infants fed this formula for more than a month after discharge could have an increased risk of developing anemia due to insufficient iron intake.  If parents have concerns about their baby's health, they should contact their baby's doctor or healthcare professional.  No other liquid or powdered Similac Infant formulas were affected. See the attached manufacturer's news release for a list of stock code and lot numbers for formula affected by this recall. "

The complete news release by the manufacturer of Similac products, Abbot's Ross Products Division, is also available at the FDA website.  Ross will replace the recalled product  free of charge to consumers who contact the company at 1-888-899-9182.

Parents with concerns about their baby's health should contact their healthcare professional immediately for alternatives. 




Posted In Patient Safety , Pediatrics , U.S. Food and Drug Administration Warnings
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Contact Lens Solution Recall: Serious Eye Infection Risk

Contact lens wearers should immediately stop using Complete MoisturePlus Multi Purpose Solution and discard all partially-used or unopened bottles.  Reports of a rare and extremely serious eye infection have been linked to the solution.  The infection, Acanthamoeba keratitis, is caused by a parasite and may lead to vision loss with some patients requiring a corneal transplant.  Normally healthy people who wear contact lenses may be affected by the parasite.  During a recent investigation by the Centers for Disease Control (CDC), users of the Complete MoisturePlus Multi Purpose Solution were at least seven times more likely to develop Acanthamoeba keratitis than those who used another brand.

According to an announcement by the director of the Center for Devices and Radiological Health of U.S. Food and Drug Administration(FDA), the manufacturer of the product, Advanced Medical Optics,  "acted responsibly in taking this voluntary action and support their decision to be proactive in the interest of public health.  FDA and CDC are working closely with the company to collect additional information and we will continue to  alert consumers and advise them as more information becomes available."

Consumers should consult with their doctors about alternative cleansing/disinfecting products.  If they have any symptoms of eye infection, they should seek immediate medical attention.  Early detection is critical for effective treatment of Acanthamoeba keratitis.

Continue Reading Posted In Patient Safety , Product Liability , Public Health , U.S. Food and Drug Administration Warnings
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FDA Warns of Counterfeit Weight-Loss Drug

"FDA informed consumers and healthcare professionals regarding the dangers associated with buying prescription drugs over the internet.  FDA received information showing that 24 apparently related websites may be involved in the distribution of counterfeit prescription drugs.  The website appear to be operated from outside the United States.  

On three occasions during recent months, consumers obtained counterfeit versions of Xenical 120 mg Capsules, a drug used to help obese individuals who meet certain weight and height requirements to lose and maintain weight loss, from two different websites.  Instead of receiving Xenical, a product manufactured by Hoffmann-LaRoche Inc, consumers received sibutramine, the active ingredient in Meridia.  Although Meridia is also used to lose and maintain weight loss, the drug should not be used in certain patient populations and is not a substitute for other weight loss products.  Consumers should be wary if there is no way to contact the website pharmacy by phone, if prices are dramatically lower than the competition, or if no prescription from their doctor is required.  Additionally, consumers are urged to review the FDA web page at www.fda.gov/buyonline for additional information prior to making purchases of prescription drugs over the internet.  See FDA press release for the list of the 24 web site that may be involved in the distribution of counterfeit prescription drugs. "

Read the complete 2007 MedWatch 2007 Safety summary, including a link to the FDA Press Release regarding this issue at the MedWatch section of FDA's website.


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PharmaFab Agrees to Stop Manufacture and Distribution of Drugs

PharmaFab, Inc., a major manufacturer and distributor of more than 100 different prescription and over-the-counter drugs, has been ordered by the FDA to stop the illegal manufacture and distribution of drugs.  The company did not produce the drugs according to the required current good manufacturing practice (CGMP) and may not have obtained required FDA approval. 

Many of the drugs produced by the company are cough and cold products, ulcer treatments, and postpartum hemorrhage products.  Consumers are advised to consult with their doctors if using any products by PharmaFab.

Drugs made by PharmaFab include, but are not limited to:

  • De-Congestince Sustained Release Capsules;
  • GFN 1200/DM 60/PSE 60 Extended Release Tablets;
  • Rhinacon A Tablets;
  • Sudal 12 Chewable Tablets;
  • Histex PD 12 Suspension;
  • Atuss HX CIII;
  • Ergotrate Tablets;
  • Hyoscyamine Sulfate Time-Release Capsules.

Standards established by current good manufacturing practice (CGMP) include investigating manufacturing failures, having an effective quality control unit, and establishing reliable expiration dates for products.  Compliance is necessary to make certain that drugs have the required safety, identity, strength, quality, and purity.  Because of lack of compliance with CGMP, PhamaFab is required to destroy certain illegal drugs and not distribute any drugs until after obtaining required FDA approval and comply with CGMP.

The FDA news release regarding PharmaLab is available on the FDA website.

Before taking any medication, please consult with your doctor first.

Posted In Patient Safety , U.S. Food and Drug Administration Warnings
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FDA Warning: Buying Prescriptions Online

"FDA informed consumers and healthcare professionals regarding the possible dangers of buying prescription medications online.  Individuals who ordered Ambien, Xanax, Lexapro, and Ativan over the internet received a product that contained haloperidol, a powerful anti-psychotic drug.  Several consumers experienced difficulty in breathing, muscle spasms and muscle stiffness after ingesting the suspect product and had to seek emergency medical treatment. Haloperiodol can cause muscle stiffness, spasms, agitation and sedation.  Taking medication that contains an active ingredient other than what is prescribed by qualified healthcare professionals is generally unsafe.  FDA urges consumers to review the FDA website for additional information prior to making purchases of medications over the internet."

To review the complete MedWatch 2007 Safety summary, please see the FDA press release regarding this issue.




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FDA WARNING: Counterfeit Drugs Enter the Supply Chain

In a Fall 2006 release, the FDA urged consumers not to buy drugs on line from Canadian pharmacies.  The FDA’s 2005 crackdown found that 85% of drugs intercepted from “Canadian pharmacies,”  actually came from 27 other countries.

In particular, the FDA is urging consumers not to purchase any medications from websites that have orders filled by Mediplan Prescription Plus Pharmacy or Mediplan Global Health in Manitoba, Canada. The FDA is currently investigating reports that these companies are involved in the distribution of counterfeit drugs to US consumers.

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FDA MedWatch Warning: Compounded Topical Anesthesia Creams

"FDA notified healthcare professionals and consumers about the serious public health risks related to compounded topical anesthetic creams. FDA issued warning letters to five firms to stop compounding and distributing standardized versions of topical anesthetic creams, marketed for general distribution. Exposure to high concentrations of local anesthetics, like those in compounded topical anesthetic creams, can cause grave reactions including seizures, irregular heartbeats and death. Compounded topical anesthetic creams are often used to lessen pain in procedures such as laser hair removal, tattoos, and skin treatments. They may be dispensed by clinics and spas that provide these procedures, or by pharmacies and doctors' offices. "

For the complete FDA press release, please click here.
Posted In U.S. Food and Drug Administration Warnings
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Recall of 500 mg Acetaminophen (Tylenol) Caplets: Metal Fragments Found in Caplets


The Federal Drug Administration (FDA)  and Perrigo Company notified the public of a voluntary recall of 383 lots of acetaminophen 500 mg caplets manufactured and distributed under various store-brands.  The concern is that small metal fragments were found in some of these caplets. The FDA has a list of stores that carry store-brands potentially affected by this recall, as well as batch numbers affected, on the their website (referenced above). 

According to the FDA, there have been no injuries reported yet and no consumer complaints have been reported to the FDA. Based on limited information available, the FDA believes the probability of serious adverse health consequences is remote; however, they do warn that if a consumer were to swallow an affected caplet, it could result in possible cuts to the mouth or throat. 

Consumers should consult their physician immediately if they suspect they may have been injured by this product.  You should save the entire bottle and the contents as well.

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Guidant Settlement In Defibrillator Fraud Suit

Just days before trial was scheduled to begin, Guidant Corporation, a subsidiary of Boston Scientific, settled a fraud suit for an undisclosed amount, according to The New York Times.  The plaintiffs claimed that the company failed to warn them that their implanted defibrillators might malfunction and knowingly chose to sell off a defective inventory.  Guidant has recalled thousands of implantable defibrillators since June 2005.  

The settlement comes following a meeting between the U.S. Food and Drug Administration (FDA) and Guidant to discuss the removal of several models of pacemakers and implantable defibrillators from hospital inventories due to defectiveness.  The defect in these devices involves a component that controls how the device holds its power supply.  The defect may cause the device to lose power and malfunction, causing intermittent or permanent loss of therapy, premature battery depletion or other malfunctions.  Earlier this year, Guidant issued a press release regarding its XIENCE V Everolimus Eluting Coronary Stent, a device that is not classified as an implantable defibrillator, stating that a small percentage of the inventory "was not manufactured with strict adherence to its quality standards." 
   

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FDA Recall: Triaminic Vapor Patch Possibly Dangerous for Children

According to the U.S. Food and Drug Administration (FDA) Public Health Advisory, consumers should not use the Triaminic Vapor Patch, a children's cough suppressant.  Novartis Consumer Health, the manufacturer of the Triaminic Vapor Patch, is voluntarily reacalling the patch because it may cause serious harm to children who accidentally ingest it.

The Triaminic Vapor Patch is advertised as a cough suppressant for children over the age of two. The package label instructs consumers to apply the patch to the throat or chest. However, once applied, a child who may be enticed by the patch’s cherry or menthol scent can easily remove and swallow the product.

The patch contains camphor, eucalyptus oil, and menthol, ingredients that can cause symptoms that range from minor to life-threatening, including a burning sensation in the mouth, headache, nausea and vomiting, and seizures. The FDA is aware of one report in Canada associated with the identical version of the Triaminic Vapor Patch where a two year old child was reported to have had a seizure after chewing the medicated patch.

 

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FDA Warning: Brazilian Diet Pills

The U.S. Food and Drug Administration (FDA) warned consumers not to use two unapproved Brazilian dietary supplement pills, marketed as “Emagrece Sim Dietary Supplement,” also known as the Brazilian Diet Pill and “Herbathin Dietary Supplement,” as they “may contain several active ingredients, including controlled substances, found in prescription drugs that could lead to serious side effects or injury.” Continue Reading Posted In Patient Safety , U.S. Food and Drug Administration Warnings
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Lax Inspection of Organs for Transplants Poses Huge Risks for Patients

Heart valves and ligaments taken from cadavers destined for transplants in patients across the USA are less likely to undergo strict government inspection than fruit for sale in your local grocery store. According to the FDA's own data, only 1 out of every 8 companies registered to process cadaver tissue for use in surgeries ever receives an inspection. The list of companies participating in this billion dollar business has increased from 406 to 2030 in the last five years.

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Decrease in Food and Drug Administration Warnings

According to a recent report released by the House Government Reform Committee, the number of serious "warning letters" by the Food and Drug Administration (FDA) has decreased by almost 50% during the past five years.  In some cases, the FDA rejected recommendations by on-site investigators that violations had led to serious injuries or deaths.   The report was released by Congressman Henry Waxman's office on June 26, 2006.  "Waxman requested the study because of reports that FDA inspectors who identified problems at Chiron Corp's flu-manufacturing plant in England were overruled by their supervisors. British drug authorities closed the plant because of manufacturing problems, leaving the United States with a major shortage of flu vaccine for the winter of 2004-2005," according to a related Washington Post story

Three key conclusions of the report include:
1) FDA enforcement actions have declined by over 50% during the past five years.
2) FDA headquarters officials have routinely rejected the enforcement recommendations
    from agency field inspectors.
3) FDA's recordkeeping and case tracking practices are inadequate.  The FDA does not
    track enforcement recommendations.

In response to the report by the House Government Reform Committee, the Office of Enforcement Director David Elder released the following statement: "FDA enforcement cannot be properly judged by counting the number of actions taken by the agency.  FDA has increasingly used an enforcement strategy based on efficient risk management principles that focus on combating the greatest public health risks and maximizing our deterrent effect against potential violators."

The report by Waxman's office was released just before the 100th anniversary of FDA.  Two watchdog groups plan a news conference to highlight FDA's current failures. 

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Deaths Following Medical Abortion: April 10, 2006 Update

It is remarkable how quickly pharmaceutical products can move through the regulatory approval process, so much so that one might question the effectiveness of research and development by manufacturers. Since the approval of mifepristone (marketed as Mifiprex) in September 2000, the U.S. Food and Drug Administration (FDA) has received reports of six deaths in the United States following medical abortion with mifepristone and misoprostol. Of the two most recent deaths reported to FDA in March 2006 (see DC Metro Area Medical Malpractice Law Blog, Deaths Following Administration of Medical Abortion), one has been determined to be unrelated to an abortion or to the use of these medications, while the other, with symptoms of infection, continues to be under investigation. According to previous FDA reports, four women in the United States have died from sepsis (severe illness caused by infection of the bloodstream) after medical abortion with mifepristone and misoprostol. All four women were infected by the same type of bacteria. While sepsis is a known risk of abortion in general, the symptoms in these four cases were not typical of sepsis. FDA has tested batches of mifepristone and misoprostol and has not found any contamination with the type of bacteria involved in the four cases. FDA recommends that women who have taken these medications for medical abortion contact a healthcare professional immediately if they develop stomach pain or discomfort, or have weakness, nausea, vomiting, or diarrhea with or without fever, more than 24 hours after taking the misoprostol.

Posted In Medications , Obstetrics , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Internal Documents Reveal Deception by the U.S. Centers for Disease Control and Prevention Regarding the Role of Vaccines in Autism

All too often, we find that clients have not been provided with complete information and, as a result, have not been given the opportunity to make informed decisions with regard to their own care or the care of a loved one. According to Generation Rescue, a nonprofit organization formed by parents of children diagnosed with autism and other developmental disorders, the U.S. Centers for Disease Control and Prevention (CDC) has minimized or attempted to conceal the association between childhood vaccines and autism. On April 6, 2006, Generation Rescue launched a website, www.PutChildrenFirst.org, and placed a full page advertisement in USA Today with regard to its allegations and the basis for them. Many parents and scientists believe that autism and other neurological disorders, including Attention Deficit Disorder/Attention Deficit Hyperactivity Disorder (ADD/ADHD) and sensory integration disorder, are caused by the toxic metal mercury, a key ingredient in a vaccine preservative called thimerosal. Through the Freedom of Information Act, parents of autistic children obtained numerous internal documents from CDC, the U.S. Food and Drug Administration, the Institute of Medicine, and the U.S. Congress regarding this connection between vaccines and autism. According to Generation Rescue, one such document is an email and spreadsheet from a CDC epidemiologist showing an extremely high correlation between mercury received through vaccines and autism, with the researcher writing that the correlation "just won't go away." Another is a transcript from a meeting held by CDC during which health officials reported that "the number of dose-related relationships [between thimerosal and autism] are linear and statistically significant" and that CDC's data should be kept out of "less responsible hands."

During the last decade, CDC, as the agency responsible for the National Immunization Program, dramatically increased the number of recommended immunizations for children, nearly tripling the amount of mercury injected into children and grossly exceeding federal safety standards. During this period, rates of autism also dramatically increased, and Generation Rescue reports that more than 1 in 150 children are currently diagnosed with autism, as compared to 1 in 10,000 in the 1970s.

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Recall of ACCU-CHEK Ultraflex Infusion Sets

FDA MedWatch announced a voluntary recall of all ACCU-CHEK Ultraflex Infusion Sets by the manufacturer, Disetronic Medical Systems, Inc. on April 4, 2006. The tubing for the units has a potenial to fully or partially separate at the luer lock-tubing connection, allowing insulin to leak and causing an interruption of insulin delivery. Hyperglycemia could result. Symptoms of hyperglycemia include:
- nausea/vomiting,
- blurred vision,
- excessive thirst or hunger,
- fatigue/tiredness/sleepiness,
- headache,
- fruity acetone breath,
- abdominal pain.
Patients with these symptoms should check their blood glucose level and follow the medical advice of their healthcare professional if the blood glucose level is not within the acceptable range.

Under this recall, customers may replace their ACCU-CHEK Ultraflex Infusion Set with ACCU-CHEK Tender of ACCU-CHEK Rapid-D infusion sets.

The complete MedWatch summary and press release is available at the FDA website.

For further information, contact ACCU-CHECK Customer Care Center or call 1-800-858-8072.

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Public Health Advisory: Telithromycin and Liver Toxicity

As recently reported in the Annals of Internal Medicine, there have been three cases of serious liver toxicity in individuals taking telithromycin (also known as Ketek). Telithromycin is an antibiotic of the ketolide class and was the first of this class to be approved by the U.S. Food and Drug Administration (FDA) in April 2004 for the treatment of respiratory infections in adults caused by the microorganisms Streptococcus pneumoniae and Haemophilus influenzae. These cases have been reported to MedWatch, the FDA's voluntary reporting system.

Telithromycin is marketed and used extensively in many other countries, including Japan and countries in Europe. FDA is continuing to evaluate the issue of liver problems in association with the use of telithromycin in order to determine if labeling changes or other actions are warranted. Moreover, FDA is exploring the frequency of liver-related adverse events reported for approved antibiotics in general in addition to telithromycin.

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Deaths Following Administration of Medical Abortion

The Food and Drug Administration (FDA) recently received verbal notification of two deaths in the United States following medical abortion with mifepristone and misoprostol. The notification was given by the drug's manufacturer, Danco Laboratories. While the FDA investigation is ongoing and the causes of these deaths have not been confirmed, the FDA has recommended that all providers of medical abortion and their patients be aware of the specific circumstances and directions for use of the drug as well as all attendant risks, including sepsis. In particular, providers and their patients should fully discuss early signs and symptoms that may warrant immediate medical evaluation, such as nausea, vomiting, or diarrhea, weakness with or without abdominal pain, all without fever or other signs of infection more than 24 hours after taking misoprostol.

As previously reported in its July 19, 2005 Public Health Advisory, updated on November 4, 2005, the FDA is aware of four previous confirmed deaths from sepsis in the United States, from September 2003 to June 2005, in women following medical abortion with mifepristone and misoprostol.

Information pertaining to these medications can be found at the FDA's Drug Information Page. For additional information regarding medication warnings in general, please visit the FDA's Medwatch site.

Posted In Medications , Obstetrics , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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FDA Warning: Potential Infections in Human Tissue Used During Surgery

The FDA recently updated a previous warning sent to healthcare professionals regarding human tissues recovered by BioMedical Tissue Services (BTS).

The tissue implanted in other patients included human skin, tendons and bone. BTS recovered this tissue from human donors who may not have met the FDA donor eligibility requirements and who may not have been properly screend for certain infectious diseases. As part of an ongoing investigation, the FDA has become aware of additional information regarding the reliability of donor blood samples that is important for health care providers to consider. In this report, the FDA strongly recommends that health care providers inform their patients who received tissue implants from BTS donors that they may be at increased risk of communicable disease transmission and to offer them testing. While the FDA believes the risks from these tissues are low because the tissues were routinely processed using methods to help reduce the risk of infectious disease, the actual infection risk is unknown.

You can read the complete FDA summary, including links to the Public Health Notification and previous advisories, at FDA MedWatch.

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Steroid Warning: Dietary Supplements

Recent news articles have discussed the ongoing investigation into the use of performance enhancing steroids by major league baseball players. This investigation has led to the FDA's heightened awareness of the dangers associated with steroids and their widespread use. Steroid use extends beyond professional athletes and includes high school and recreational athletes as well as dieters.

"The Food and Drug Administration (FDA) warned several manufacturers and distributors of unapproved drugs containing steroids that are marketed as dietary supplements and promoted for building muscle and increasing strength that the products may cause serious long-term adverse health consequences in men, women, and children. These products claim to be anabolic and problems associated with anabolic steroids include: liver toxicity, testicular atrophy and male infertility, masculinization of women, breast enlargement in males, and short stature in children. Anabolic steroids are also associated with causing adverse effects on blood lipid levels, and a potential to increase the risk of heart attack and stroke.

Consumers who have any of the following products should stop taking them and return them to their place of purchase:

Anabolic Xtreme Superdrol- manufactured for Anabolic Resources LLC, Gilbert, Arizona
Methyl-1-P, manufactured for Legal Gear, Brighton, MI

Read the complete MedWatch 2006 Safety summary, including links to the FDA Press release and Warning Letters to manufacturers and distributors of illegal steroid products sold as dietary supplements at:

http://www.fda.gov/medwatch/safety/2006/safety06.htm#steroids"

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Recall of Gentlease Baby Formula - Found to Contain Metal Particles

"Mead Johnson and FDA notified the public of a recall of one lot, lot # BMJ19, of GENTLEASE powdered infant formula, found to contain metal particles up to 2.7 millimeter in size. If an infant were to inhale the infant formula into the lungs, the presence of these particles could present a serious risk to the infant's respiratory system and throat.

There were approximately 41,464 24-ounce cans of this lot of recalled product distributed, beginning on December 16, 2005, through many major retail stores across the country, so the consumer should concentrate on the code on the can rather than on the place of purchase. The affected products can be identified by the lot number and expiration/use by date embossed on the bottom of the can of BMJ19, use by 1 Jul 07. Consumers who have a can of this batch of GENTLEASE powdered infant formula should not use the product and should contact Mead Johnson at 888-587-7275 immediately."

To read the complete recall notice please go to:

http://www.fda.gov/medwatch/safety/2006/safety06.htm#gentlease

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Pregnancy and Paxil: Not in the First Trimester

According to The Center for Drug Evaluation and Research of the U.S Food and Drug Administration, preliminary results of two important studies indicate that the popular antidepressant Paxil (also known as Pexeva or paroxetine) increases the risk of congenital defects, particularly cardiovascular malformations, when taken during the first trimester of pregnancy. Based on these findings, Paxil's pregnancy category has been changed from "C" to "D," indicating that studies show that its use in pregnant women have demonstrated an associated risk to the fetus. For these reasons, Paxil should generally not be initiated in women who are in their first trimester of pregnancy or in women who plan to become pregnant. Women already taking Paxil who become pregnant or who are currently in their first trimester of pregnancy should be alerted to the potential risk to the fetus and counseled regarding whether Paxil should be discontinued and possibly replaced by another antidepressant. For certain women, however, the benefits of continuing Paxil may outweigh the potential risk to the fetus. The FDA is currently awaiting the final results of the recent studies and accruing additional data pertaining to the use of Paxil in pregnancy in order to better characterize its associated risks. The FDA will provide updates as new information becomes available.

Posted In Medications , Obstetrics , Product Liability , U.S. Food and Drug Administration Warnings
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Warning: Miracle II Neutralizer and Neutralizer Gel Products

The U.S. Food and Drug Administration issued a December 6, 2005, warning from MedWatch, the FDA's safety information and adverse event reporting program. According to the FDA warning, consumers are advised not to use the Miracle II Neutralizer and Neutralizer Gel products. These products are bacterially contaminated and have not been proven to be safe and effective. They are marketed as cleaners, deodorizers, natural insecticides and antibacterial agents. Despite the FDA notification, the manufacturer, Tedco, Inc., has declined to voluntarily remove the products from the market. The FDA's MedWatch program requests that any adverse events related to Miracle II products be reported by phone at 1-800-FDA-1088 or by using the FDA MedWatch online reporting form.

Tedco's promotional health claims for the Miracle II Neutralizer products were categorized by the FDA as "deceptive and untruthful." Although Miracle II naturalizer products have been promoted for treatment of cataracts and pinkeye, as well as an eyewash, FDA investigations revealed bacterial contamination and poor manufacturing conditions. Consumers are advised to discontinue using the products and dispose of them.

Posted In Product Liability , U.S. Food and Drug Administration Warnings
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Infant Teether Recall

On January, 27, 2006, the FDA and The First Years announced a voluntary recall of liquid-filled teethers. The fluid inside the teethers may possibly contain bacterial contamination, which could cause serious illness in children if the teether is punctured.

Consumers should immediately stop using the following products:
* Disney Days of Hunny Soft Cool Ring Teether--Style# Y1447
* Disney Soft Cool Ring Teether--Style# Y1470
* Disney Soft Cool Ring Teether--Style# Y1490
* The First Years® Cool Animal Teether/Fish, Zebra and Dinosaur designs--Style# Y1473
* The First Years® Floating Friends Teether-- Style# Y1474
* Sesame Beginnings™ Chill & Chew Teether-- Style# Y3095

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Foodborne Illness: Prevention through Education

Foodborne illness, an underreported and preventable disease, is a public health and economic challenge affecting both general and at-risk populations. More than 200 known diseases are transmitted through food, the causes of which include organisms, such as viruses, bacteria, and parasites, as well as toxins and other substances. The signs and symptoms of foodborne illness range from mild gastrointestinal problems to serious life-threatening conditions affecting the liver, kidneys, and neurological system. In the United States alone, foodborne diseases have historically been estimated to cause illness in millions of Americans and thousands of deaths each year.

In 1998, the U.S. Food and Drug Administration's National Retail Food Team launched a long-term study investigating food preparation handling and practices most commonly reported to the Centers for Disease Control and Prevention as contributing factors in foodborne illness outbreaks. Specifically, this study involves inspection of foodservice and retail food establishments in order to observe and document the occurrence "foodborne illness risk factors," such as food from unsafe sources, inadequate cooking, poor personal hygiene, and equipment contamination. The study is intended to continue through the year 2008.

Posted In Men's Health Issues , Pediatrics , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Pemoline Withdrawn as Approved Drug for ADHD

Attention Deficit Hyperactivity Disorder (ADHD) has become a prevalent diagnosis among children in recent years. Consequently, numerous drugs have been developed and prescribed to children to treat this disorder. In October, the U.S. Food and Drug Administration withdrew approval for pemoline, a drug used to treat ADHD, because it has been associated with liver problems, including death. The drug was sold under the name Cylert and originally developed by Abbott Laboratories. Earlier this year, Abbott discontinued production of Cylert, but generic versions continued to be produced and remain available. Even though pemoline or Cylert has been associated with liver problems and death, the FDA did not recall the drug. Public Citizen, a consumer advocacy group, criticized the FDA's failure to issue a recall of the drug calling it "reckless and insensitive to the health and lives of children and adults using this drug . . .." For an additional story about Cyclert, also see the October 24, 2005 online edition of MSN Health & Fitness - Health Highlights .

Posted In Medications , Pediatrics , Product Liability , U.S. Food and Drug Administration Warnings
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Landmark Study to Evaluate Drug Safety

The Cleveland Clinic, recently ranked by U.S. News & World Report as the best cardiac care center in the nation, will lead a massive international study to evaluate whether painkillers taken by millions of Americans for arthritis are safe for those who are also at risk for cardiovascular problems. The study will be led by Steven Nissen, M.D., who, incidentally, called for studies on the cardiovascular risks of Celebrex and Vioxx in a 2001 report. It is anticipated that it may take 18 months to enroll all of the 20,000 study participants, who will then be monitored for two years. The study will be funded by Pfizer Inc., the maker of Celebrex, a popular arthritis medication.

With an unusual mix of industry, academic researchers, and government oversight, the study aims to restore public confidence in pharmaceutical products. The credibility of research and drug safety assurances in particular has been called in to question by American consumers over the years. Public concerns have been amplified more recently, however, since products such as Vioxx and Bextra were withdrawn from the market due to evidence that they can raise the risk of a heart attack or stroke. "Since so many arthritis patients are at risk for heart disease, it is critically important to understand the cardiovascular safety of these drugs,'' said Dr. Nissen. "Currently available information is insufficient to determine whether typical dosages of celecoxib [Celebrex] and other popular pain relievers are linked to an increased risk of heart disease."

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MedWatch: FDA Safety Information and Adverse Event Reporting Program

MedWatch is the safety information and adverse event reporting program for the U.S. Food and Drug Administration. According to FDA guidelines, consumers and healthcare professionals may use this website for timely safety information on drugs and other regulated medical products. In addition, consumers may register to receive notices of new warnings and complete online reporting forms for medical products and/or medications.

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Ortho Evra Birth Control Patch Found Dangerous

The U.S. Food and Drug Administration (FDA) recently acknowledged what experts have been saying for months: Ortho Evra (manufactured by Ortho-McNeil) birth control patches are dangerous. The agency warned that "women who use Ortho Evra are exposed to about 60 percent more estrogen than if they were taking a typical birth control pill." Increased estrogen means increased risks, including the increased risk of life-threatening blood clots.

Continue Reading Posted In Medications , Obstetrics , Product Liability , U.S. Food and Drug Administration Warnings , Women's Health Issues
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