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:

 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:

 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:

 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:

 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:

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 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:

 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:

 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:

 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:

 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:

 Posted by: Salvatore J. Zambri, founding partner     

 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:

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.

 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:

 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:

 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:

 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:

 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:

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 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:

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. 

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:

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:

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:

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:

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:

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:

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:

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:

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:

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 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 contact Mr. Zambri at 202-822-1899 or email him at szambri@reganfirm.com.

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.

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 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 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 us at Regan Zambri & Long, PLLC at 202-463-3030. 

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 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 us at Regan Zambri & Long, PLLC at 202-463-3030.

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 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 us at Regan Zambri & Long, PLLC at 202-463-3030.

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 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 us at Regan Zambri & Long, PLLC at 202-463-3030.

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 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 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 us at Regan Zambri & Long, PLLC at 202-463-3030.

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 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 us at Regan Zambri & Long, PLLC at 202-463-3030.

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 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 us at Regan Zambri & Long, PLLC at 202-463-3030.

"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 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 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 us at Regan Zambri & Long, PLLC at 202-463-3030.

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 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 us at Regan Zambri & Long, PLLC at 202-463-3030.

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.

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 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.

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. 

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," 

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 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.

"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 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."

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.

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.”

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."

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."

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.

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

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.

  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.

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

              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.

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?

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.

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.

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.

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.

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. 

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.

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.

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.

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.

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.

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. "
  

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.

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. 

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.

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.

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:

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.

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.

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:

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:

• 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)
  

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.

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. 

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. 

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.

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.

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.

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.

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 For historical information regarding mifepristone and misoprostol, please see Historical Information on Mifepristone (marketed as Mifeprex).

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.

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.

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.

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.

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.

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"

"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

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.

To view the FDA alert regarding the use of Paxil in pregnancy, please click here. To visit the manufacturer's website, please click on GlaxoSmithKline.

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.

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

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.

To view a complete report on this ongoing study, please click here. For important information from the U.S. Department of Agriculture regarding food safety education, including online question and answer sessions, please click here.

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 .

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."

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.

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.