Consumers continue to be placed at risk as pharmaceutical companies race to market

The FDA recalls & warnings of 2010 reads like a who’s who list in big pharmaceutical companies. It includes household brand names like Tylenol, Johnson & Johnson’s DePuy hip implants, heartburn pills Prilosec OTC & Nexium, Bayer’s Yaz Birth Control, and smoking-cessation drug Chantix.

In early 2010, the Simmons firm claimed a national leadership role in the on-going Yaz litigation when the cases were consolidated and centralized to the Southern District of Illinois in East St. Louis. More than 70 women suffered serious injuries after taking Yaz or Yasmine, a previously popular birth control bill, including heart attacks, pulmonary embolisms, gallbladder disease and sudden death, according to the FDA.

The firm also claimed a leadership spot on the committee to manage national litigation regarding the Chantix cases. Chantix, a drug used to help people overcome their smoking addictions, was linked to suicidal thoughts and actions, as well as behavior and mood disorders, as early as 2008. FDA officials warned that those taking the drug should stop immediately should they experience those behaviors.

Probably the most visual recall thanks to extensive coverage by the media here & here were the Tylenol recalls. The only good news is if you missed the recall of liquid children Tylenol & Motrin when it happened, there’s nothing to be unsure about. Don’t use it! According to Tylenol’s website, they don’t anticipate stocking shelves with safe infant & children’s liquid medicine until the spring.

As the year progressed, so did the FDA’s warnings with the news that long-term use of heartburn pills increased people’s risk of fracturing their wrists, hips and spine. Millions of people this past year bought over the counter versions of Nexium and Prilosec OTC to treat their long-term heartburn. The popular use of antacid drugs motivated FDA officials to re-label the prescription and over the counter versions to warn consumers of the dangers of long-term use longer than a year.

The fall brought yet another recall. An unpublished study revealed new data showing defects in DePuy Orthopaedic hip implants that caused an unexpected increase in the rate of second surgeries needed. The recall involves the ASR XL Acetabular System and DePuy ASR Hip Resurfacing System. At least 12 to 13 percent of patients who received either the Acetabular System or the Hip Resurfacing System have required follow-up surgeries and five-year revisions.

The year ended with the FDA pulling Darvon and Darvocet, or propoxyphene, from retailers' shelves because research found it can cause serious heart rhythm abnormalities. European regulatory agencies had banned the popular pain killer drug more than a year ago, while the U.S. medical community has raised concerns about the drug since it was first approved 1957.

As an advocate for consumers’ rights, the Simmons law firm will continue to keep you updated on the FDA’s investigations and its findings as we continue into 2011. Click here to read more about the Simmons pharmaceutical division. Comments (0)

FDA Pulls Darvon, Darvocet from Market for Heart Risks

The maker of the pain killer medicine known as Darvon and Darvocet, or propoxyphene, announced last week it will stop making the popular drugs because it can cause serious heart rhythm abnormalities, according to a new study.

Xanodyne Pharmaceuticals Inc. agreed to the ban Darvocet, Darvon and its generic versions at the request of the Food & Drug Administration. The new ban brings the drug in line with European regulatory agencies that banned the drug more than a year ago.

The new study indicates that even when Darvon or Darvocet is taken at the recommended dosages, “there were significant changes to the electrical activity of the heart.” The new findings outweigh the potential benefit, the FDA said in a statement.

While it’s good the FDA is finally pulling Darvon and Darvocet from the market, it’s disconcerting that it’s taken this long for it to do so. In 2009, an FDA committee voted 14-12 against the continued making of propoxyphene products but noted additional information would be helpful. The FDA required the drug maker to conduct the study, and its results confirm concerns the medical community has raised about the drug since it was first approved by the FDA in 1957.

"We recommend to physicians stop prescribing the drugs. As for patients, do not stop taking it, but we urge you to contact your health care professional. Do not delay," Gerald Dal Pan, director of the FDA's Office of Surveillance and Epidemiology, told CNN last week.

Since 2009, more than 10 million patients have been prescribed some form of propoxyphene, according to the FDA. The Simmons law firm is currently investigating claims on behalf of those patients injured due to taking Darvon, Darvocet or the generic versions of propoxyphene. Click here to learn more about the Simmons pharmaceutical injury division.
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Hip Implants Recalled by Johnson and Johnson DePuy

According to the Wall Street Journal and other news sources, Johnson & Johnson's orthopaedic-device unit, DePuy Orthopaedics, Inc., announced recalls of some hip-replacement devices due to data on the rate of second surgeries needed. The voluntary recall came amid a string of quality-control problems at its non-prescription drug operations. Patients are being advised to visit their surgeons to evaluate their implant performance, which DePuy said should be done annually in any case.

The recall involves the ASR XL Acetabular System and DePuy ASR Hip Resurfacing System. At least 12 to 13 percent of patients who received either the Acetabular System or the Hip Resurfacing System have required follow-up surgeries and five-year revisions.

The Hip Resurfacing System has been available since 2003 for use outside the U.S., whereas the Acetabular System has been in use in the U.S. and worldwide since 2004. Both systems have been highly preferred by surgeons in cases of young patients because of the initially reduced chance of dislocation provided by both devices.

New, unpublished data showed a five-year revision rate being much higher than previously reported. One in eight patients needed a second surgery, according to data compiled from the National Joint Registry of England and Wales. Females saw the highest rates. Prior post-market data had shown lower revision rates and that its ASR hip was performing "in line with other devices in its class."

David Floyd, president of DePuy Orthopaedics, said the company is "committed to paying for the cost of doctor visits, tests and procedures associated with the recall." The company said in a statement that it "intends to cover reasonable and customary costs of monitoring and treatment for services, including revision surgeries.

As an advocate for consumers’ rights, the Simmons law firm will keep you updated on the FDA committee’s recommendations. Click here to read more about the Simmons pharmaceutical division. Comments (0)

Simmons Law Firm Monitors Tylenol Recalls, FDA Investigation

Due to reports of serious side effects, McNeil, a division of Johnson & Johnson, has made four major recalls of over-the-counter products, including Tylenol, Motrin and Benadryl, in the past seven months.  The most recent occurred May 1.

An article posted Tuesday on CNNmoney.com titled, “Tylenol recall: Serious side effects investigated,” states that the FDA has received at least 775 reports of people who have experienced serious side effects after taking these three drugs. The side effects include stomach pain, vomiting and diarrhea and in the more extreme cases hospitalization and disability, according to the article.

The recalls triggered investigations by the Food & Drug Administration, and now  the House Committee on Oversight and Government Reform has scheduled a May 27 hearing to investigate. Click here to read more.

As an advocate for consumers’ rights, the Simmons law firm will keep you updated on the FDA’s investigation and its findings.  Click here to read more about the Simmons pharmaceutical division.

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