Zelnorm Recall: Heart Problems

On March 30, 2007 the FDA requested that Zelnorm be withdrawn from the market after data showed that users face a statistically significant increased risk of heart attacks, strokes and angina.

The Zelnorm problems were identified after researchers reviewed data from prior clinical trials which showed users face a 7 to 8 fold increased risk of serious injury or death.

The Zelnorm recall lawyers at Saiontz & Kirk, P.A. previously reviewed potential lawsuits on behalf of individuals who suffered an injury.  The manufacturer failed to adequately warn of the risk of heart attacks, strokes, angina, gastrointestinal injuries and ischemic colitis which have been associated with the drug. As a result,

ZELNORM REMOVAL FROM THE MARKET

At the time Zelnorm was removed from the market, it was one of the top 200 brand-name prescription medications in the United States.  At least 500,000 people were actively taking the drug at the time of the Zelnorm recall, and over 2.6 million prescriptions were written in 2006.

Initially Zelnorm (generic tegaserod maleate) was approved for short-term treatment of women with irritable bowel syndrome whose primary problem is constipation.  In August 2004, the FDA expanded the approved uses to include treatment of men and women under 65 who experience chronic constipation.  However, many patients have received the drug off-label for non-approved uses as a result of aggressive promotion by the drug manufacturer.

Novartis Pharmaceutical Corporation heavily advertised the drug directly to consumers with an ad campaign featuring young women’s abdomens with words written on them.  The ads were not designed to educate doctors about the benefits the IBS drug could offer to their patients, but rather to encourage patients to ask their doctors to prescribe the drug.  Novartis executives have acknowledged that their sales are directly tied to the advertisements.  Sales data reflects that the weeks the ads were off the air, sales growth would flatten, and when the ads were restarted, the company saw growth accelerate again.

ZELNORM PROBLEMS

There have been prior reports of Zelnorm problems other than the danger of heart attacks, strokes and angina.  In 2004, the Zelnorm warning label was updated to include information about gastrointestinal side effects.  At the time FDA approval was obtained, there were also concerns that the drug could increase the rate of abdominal surgery for patients with IBS.

>>MORE INFORMATION: Zelnorm problems

The Zelnorm recall was requested by the FDA after problems were identified during an analysis of 29 prior studies which involved over 18,000 patients.  Analysis of data from clinical trials found that those who took the drug had a statistically signficant increased risk of heart attacks, strokes and worsening of chest pain known as angina, which can develop into a heart attack.

The FDA recommended a Zelnorm recall since the risk of these very serious and potentially fatal injuries greatly outweighed the limited benefits for people taking the drug for non-lifethreatening IBS (irritable bowel syndrome).  For years experts have questioned why Zelnorm was approved, since it is not very effective at resolving symptoms of constipation related irritable bowel syndrome.  For women, Zelnorm studies show that it is only 5 to 10 percent more effective than a placebo.  For men, the drug has been shown that it does not work at all.

The FDA has acknowledged that they may consider a limited re-introduction of Zelnorm if a specific population can be identified for whom the benefits of the drug outweigh the risks.  Similar programs have been established with other drugs which were removed from the market, but steps need to be taken to make sure that the drug is not used by patients for whom it is not approved and that proper warnings of the Zelnorm dangers are provided.

ZELNORM RECALL LAWYERS

Lawsuits are no longer being reviewed nationwide by the Zelnorm recall lawyers at Saiontz & Kirk, P.A. on behalf of individuals who received the IBS drug and suffered any of the following side effect injuries:

• Heart attack
• Stroke
• Angina (chest pain which can become a heart attack)
• Gastrointestinal Injuries
• Ischemic colitis (inflammation of the colon)

New cases are no longer being accepted by Saiontz & Kirk, P.A. This page is maintained for informational purposes only.