DC Metro Area Medical Malpractice Law Blog

A new study has confirmed that hospital patients given Trasylol (aprotinin), a drug used to reduce bleeding during heart surgery, are 53% more likely to die than patients who are given other anti-bleeding drugs.  The drug's manufacturer, Bayer AG, has informed the U.S. Food and Drug Administration (FDA) that it has begun removing all remaining stock of Trasylol from all pharmacies and health care facilities in the U.S.

The latest Trasylol study was released Wednesday is slated to appear in print in the May 29 issue of the New England Journal of Medicine.

New hemoglobin-based artificial blood -- still unapproved for use in the U.S., but heavily studied -- appears to raise a patient's risk of heart attack and death according to an exhaustive review of clinical research data.  This latest research was published in a recent edition of the Journal of the American Medical Association (JAMA).  The findings have spurred critics to allege that the U.S. Food and Drug Administration (FDA) put clinical trial participants in imminent danger by failing to detect or act on research data illustrating significant increases in the rates of heart attack and death reported in trials of these blood substitutes.

Though patients and even dentists are often unaware, crowns, bridges and other dental devices produced by foreign manufacturers contain dangerous levels of lead in many instances, according to an investigative report by WBNS-10 TV  -- an Ohio television station that has captured the attention of the American Dental Association (ADA) and millions of concerned patients.

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.

The U.S. Food and Drug Administration (FDA) is warning that three products:  Botox, Botox Cosmetic (Botulinum toxin Type A), and Myobloc (Botulinum toxin Type B) have been linked to fatal adverse reactions including respiratory failure.  The most severe adverse reactions have occurred in children with cerebral palsy, who rely on the drug for treatment of limb spasticity.  The FDA warns that it has not approved any Botulinum toxins for treatment of spasticity in either children or adults, though it is not advising healthcare professionals to stop prescribing the products at this time. 

Breast cancer patients who elect reconstruction surgery immediately following a mastectomy suffer substantially higher rates of surgical infection when they choose to use surgical implants, rather than their own abdominal fat, to shape their breasts.  The finding is the result of new research published in the journal Archives of Surgery. 

Levels of lead in childrens' blood which were previously thought to be safe could actually be contributing to Attention Deficit Hyperactivity Disorder (ADHD), according to researchers at Michigan State University.  Their research findings will appear in the March issue of Biological Psychiatry, the official journal of the Society of Biological Psychiatry. 

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.

At the request of the U.S. Food and Drug Administration (FDA), U.S. Marshals recently seized  more than 12,000 tubes of cosmetic eyelash product worth approximately $2 million, because the product contained undeclared bimatoprost -- a prescription drug ingredient used in the treatment of increased eye pressure.

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. 

Mattel, Inc. has announced an expanded recall of 9 million toys due to health threats posed by powerful magnets and toxic lead paint.  Approximately 1.5 million toys were recalled on August 1st, all of which had been manufactured in China.  These latest additions were also manufactured in China.  Among those magnetic toys most recently recalled are Polly Pocket toys, Barbie and Tanner sets, Doggie Daycare sets and Batman figurines.  Sarge characters from the movie Cars are being recalled due to toxic surface paint.

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.

A federal jury in Florida has awarded $5.5 million to the estate of a 28-year-old man who died of an accidental overdose of pain medication because his Duragesic narcotic patches were defective.  The single-use patches which deliver fentanyl, a narcotic, via skin absorption, are manufactured by two Johnson & Johnson subsidiaries.  A jury found the manufacturers guilty of negligence in the manufacture of the patch, and of failing to adequately warn people about its dangers. 

The U.S. Supreme Court recently agreed to hear a product liability case with significant implications for the medical device industry and for any patient treated with medical devices.  The Public Citizen Litigation Group is representing Charles Riegel, in the case Riegel v. Medtronic; a case stemming from an incident in which Mr. Riegel was seriously injured by a defective cardiac catheter.  Medtronic asserts that the Food, Drug, and Cosmetic Act preempts state laws damages actions brought by injured patients in cases where the injury resulted from a device permanently approved by the U.S. Food and Drug Administration. 

Fisher-Price and its parent company, Mattel, Inc., are recalling 83 kinds of children's toys, including Sesame Street, Sponge Bob and Dora the Explorer figures among others, because surface paint on the toys contains high levels of lead.  The U.S. Consumer Product Safety Commission (CPSC) has stated that the toys were available in most major retail stores between May 2007 and August 2007, for prices between $5 and $40.  The recall is the first ever for Fisher-Price or Mattel, Inc. involving lead paint, and the largest recall for Mattel, Inc. in nearly a decade.  No injuries have yet been attributed to the toys, which were manufactured in Chinese facilities.

Following an expanded recall of the Kugel hernia patch, The U.S. Food and Drug Administration (FDA) has inspected the headquarters of its manufacturer, Davol, Inc., and issued the company a warning, citing serious quality control problems related to the manufacture of its surgical patch and an associated fixation device.  The inspection was completed in March, 2007. 

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.

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.

Victims of pharmaceutical company misconduct won a major victory in U.S. District Court in Philadelphia Oct. 17 when Judge Stewart Dalzell rejected Novartis Pharmaceutical Corp.'s claim that the Federal Food, Drug and Cosmetic Act and FDA regulations preempt state failure-to-warn tort claims. The issue of FDA preemption has been a hot one since the FDA issued a new drug labeling regulation in January 2006. At that time, the agency claimed in the preamble to the rule that federal drug labeling regulations preempt most state failure-to-warn claims against pharmaceutical manufacturers. This new language on preemption was added to the notice of final rulemaking, even though it was never included in--and directly contradicted--the notice of proposed rulemaking. The case, Perry v. Novartis, claims use of the prescription drug Elidel for the treatment of a two-year-old's eczema caused lymphoma. Novartis argued the suit should be dismissed because the claim was preempted by FDA labeling requirements for the product, which at the time did not require a warning about the risk of cancer. Plaintiffs' counsel vigorously opposed the motion and argued that the claims should be heard by a judge and jury. Judge Dalzell agreed with much of plaintiffs' counsel's argument in his landmark ruling. While recognizing that an administrative agency is entitled to great deference in its interpretation of ambiguities in its governing statute and regulations, he concluded that the FDA was not entitled to such deference when it attempts "to supply on Congress's behalf, the clear legislative statement of intent required to overcome the presumption against preemption." Dalzell rejected the FDA position--advanced in an amicus brief--that the appropriate test is whether the warning sought by the plaintiffs "would have rendered the drug misbranded" or "would have been rejected by the agency as unsubstantiated." Instead, he adopted a far narrower rule: "to allow state law to require the addition of warnings so long as there has been no specific FDA determination as to the sufficiency of the scientific evidence to support a particular warning." Dalzell went on to reject the policy argument that the claim might disturb the delicate balance of the FDA regulatory scheme, noting, "given the recent concerns about the effectiveness of the FDA's safety monitoring of recently approved drugs, the availability of state tort suits provides an important backstop to the federal regulatory scheme."

In a November 21, 2006 release, the U.S. Public Interest Research Group (U.S. PIRG) has called for warning labels on toys with magnets after more than 4 million Mattel, Inc. play sets were recalled due to injuries to several children who swallowed magnets that fell off.  The U.S. Consumer Product Safety Commission (CPSC), which announced the recall of magnetic Polly Pocket sets as the holiday gift-buying season begins, urged shoppers to avoid buying toy sets with small magnets for children under 6. The recall does not include Polly Pocket play sets now on store shelves, which were redesigned to make them safer, according to CPSC spokesperson, Scott Wolfson.  The CPSC received nearly 200 reports of the small magnets falling from Polly Pocket dolls and accessories. Three children swallowed more than one magnet and suffered intestinal perforation that required surgery.  U.S. PIRG said the CPSC should require labels on all magnetic toys warning parents to seek immediate medical help if their child has swallowed a magnet.

On November 17, 2006, after “rigorous” scientific review, the U.S. Food and Drug Administration (FDA) approved the marketing of silicone gel-filled breast implants made by two companies for breast reconstruction in women of all ages and breast augmentation in women ages 22 and older.  The products are manufactured by Allergan Corp., Irvine, California, and Mentor Corp., Santa Barbara, California.  The approval has been highly criticized by consumer groups, including Public Citizen, which labeled them the "most defective medical device ever approved by the FDA" as well as a “terrible reminder of the double standard for women versus men” since the FDA has not approved silicone gel testicular implants because of the inadequacy of clinical trials.

The Federal Drug Administration (FDA)  and Perrigo Company notified the public of a voluntary recall of 383 lots of acetaminophen 500 mg caplets manufactured and distributed under various store-brands.  The concern is that small metal fragments were found in some of these caplets. The FDA has a list of stores that carry store-brands potentially affected by this recall, as well as batch numbers affected, on the their website (referenced above). 

According to the FDA, there have been no injuries reported yet and no consumer complaints have been reported to the FDA. Based on limited information available, the FDA believes the probability of serious adverse health consequences is remote; however, they do warn that if a consumer were to swallow an affected caplet, it could result in possible cuts to the mouth or throat. 

Consumers should consult their physician immediately if they suspect they may have been injured by this product.  You should save the entire bottle and the contents as well.

According to the Seattle Times, “the increasingly common practice of preventing strokes by using wire-mesh stents to prop open neck arteries is much riskier than the traditional method of surgically removing plaque and should be curtailed, according to two large European studies.”  The American studies, however, seem to suggest that stents are safer than surgery. 

The Idaho Department of Health and Welfare has confirmed that the toddler who died of kidney failure was infected by the same E. coli strand found in tainted spinach from the Salinas Valley, according to the Centers for Disease Control and Prevention’s latest update on the E. coli outbreak.

Just days before trial was scheduled to begin, Guidant Corporation, a subsidiary of Boston Scientific, settled a fraud suit for an undisclosed amount, according to The New York Times.  The plaintiffs claimed that the company failed to warn them that their implanted defibrillators might malfunction and knowingly chose to sell off a defective inventory.  Guidant has recalled thousands of implantable defibrillators since June 2005.  

The settlement comes following a meeting between the U.S. Food and Drug Administration (FDA) and Guidant to discuss the removal of several models of pacemakers and implantable defibrillators from hospital inventories due to defectiveness.  The defect in these devices involves a component that controls how the device holds its power supply.  The defect may cause the device to lose power and malfunction, causing intermittent or permanent loss of therapy, premature battery depletion or other malfunctions.  Earlier this year, Guidant issued a press release regarding its XIENCE V Everolimus Eluting Coronary Stent, a device that is not classified as an implantable defibrillator, stating that a small percentage of the inventory "was not manufactured with strict adherence to its quality standards." 
   

Debate continues over the safety of reusing surgical blades, forceps and other medical devices.  The practice is called "reprocessing" single use devices.  It cuts the cost of the device by half but is often done without the patient's knowledge or consent.

A federal law taking effect this fall requires companies that reprocess medical devices to put their name on the reprocessed devices.  This could help determine who is at fault when a problem occurs.

There are also concerns about infections and whether these single use devices can be safely and completely cleaned for re-use.  Reprocessed devices are soaked in sterilized solutions, disassembled and then reassembled, inspected and packaged and resealed.  According to some reports, the devices originally marked as "single use" by the manufacturer, are reused on average three to six times.

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.

A recent series of articles in the New York Times reported strange new side effects in patients taking Ambien, one of the oldest and most prescribed sleep medications. "The articles cite recent studies by Carlos H. Schenck, MD, and colleagues at the Minnesota Regional Sleep Disorders Center. Schenck told the Times that he thinks thousands of U.S. Ambien users experience sleep-related eating disorders." Sleep eating disorders were first reported in 2002 by Michael H. Silber, MD, co-director of the Mayo Clinic Sleep Disorder Center and president-elect of the American Academy of Sleep Medicine. During these episodes, patients prepare and eat food, but have no memory of it the following day. Other less common reported side effects include sleepwalking and sleep driving. The complete summary appears in WebMD.

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.

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 26, 2006, the U.S. Consumer Product Safety Commission (CPSC) issued a warning to consumers to immediately stop using and unplug the Maxi-Heat Dream Tower Heater. The model recalled is CH920 and was sold at Wal-Mart stores from August to December 2005. The wires in the oscillating heater may short-circuit and spark, creating a fire hazard. Consumers may return the heaters directly to Wal-Mart for a full refund. For additional information, call King of Fans, Inc. at (866) 443-1291 or visit http://www.kingoffans.com/.

"As the world's largest trial bar, the Association of Trial Lawyers of America (ATLA) promotes justice and fairness for injured persons, safeguards victims' rights--particularly the right to trial by jury--and strengthens the civil justice system through education and disclosure of information critical to public health and safety." Their website includes a useful resource for consumers regarding drug safety.

* Drug Safety News;
* Press Releases & Statements on Drug Safety;
* Fact Sheets on Drug Safety;
* Consumer News;
* Research on Drug Safety.

Defendant medical device maker Hillenbrand Industries Inc. reached a $337.5 million settlement in the antitrust lawsuit brought against it by plainitff Spartanburg Regional Healthcare System. Hillenbrand, which makes healthcare equipment and caskets, settled this suit which stems from a June 2003 complaint that the company's Hill-Rom unit's discounting practices harmed competition in the healthcare industry and resulted in higher prices for hospital beds and in-room products.

The settlement agreement has been approved by the United States District Court for the District of South Carolina. The settlement covers all of the plaintiff's claims as well as those of U.S. and Canadian purchasers or renters of Hill-Rom products from 1990 through the date of the agreement on February 3, 2006. All told, it is expected that this settlement will have a beneficial impact for healthcare consumers, who ultimately bear the brunt of costs that are passed along by healthcare providers such as Spartanburg.

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

The U.S. Consumer Product Safety Commission (CPSC) is the government agency responsible for informing consumers about dangerous products. The introduction to the USPC website states:

"The U.S. Consumer Product Safety Commission is charged with protecting the public from unreasonable risks of serious injury or death from more than 15,000 types of consumer products under the agency's jurisdiction. Deaths, injuries and property damage from consumer product incidents cost the nation more than $700 billion annually. The CPSC is committed to protecting consumers and families from products that pose a fire, electrical, chemical, or mechanical hazard or can injure children. The CPSC's work to ensure the safety of consumer products - such as toys, cribs, power tools, cigarette lighters, and household chemicals - contributed significantly to the 30 percent decline in the rate of deaths and injuries associated with consumer products over the past 30 years."

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."

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Baxter International Inc. recently announced its withdrawal of a medication delivery pump from the market over the next 12 months as it continues to struggle with problems in its pump business. The withdrawal of the 6060 Multi-Therapy Infusion pump follows Baxter's much larger recall in early 2005 of its Colleague Infusion and Syndeo PCA Syringe pumps, which are used to administer medication in hospitals.

For more information about this and other recalls of Baxter products, see the July 2005 Food and Drug Administration news release.

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.