Zelnorm Facts:

On March 30, 2007, the U.S. Food and Drug Administration requested that Novartis withdraw Zelnorm from shelves, due to alleged a relationship between prescriptions of the drug and increased risks of heart attack or stroke. On the same day, Novartis Pharmaceuticals Canada announced that it was suspending marketing and sales of the drug in Canada in response to a request from Health Canada.

An analysis of data collected on over 18,000 patients demonstrated adverse cardiovascular events in 13 of 11,614 patients treated with Zelnorm (a rate of 0.11%) as compared with 1 of 7,031 patients treated with placebo (a rate of 0.01%).

The findings of this analysis are particularly troubling since Zelnorm is not a very effective drug and users are generally younger, otherwise healthy individuals. The FDA realized that the medication provides little or no benefit for most users and the risk of death or serious injury far outweighed the benefits in treating non-life threatening irritable bowel syndrome.

Novartis claims that all of the affected patients in this study had preexisting cardiovascular disease or risk factors for such, and further states that no causal relationship between tegaserod use and cardiovascular events has been demonstrated; however, they have agreed to withdraw all Zelnorm products from the market.

Usage:

Zelnorm (Tegaserod Maleate) is manufactured by Novartis Pharmaceutical Corporation. The medication was approved by the FDA in July 2002 for treatment of irritable bowel syndrome (IBS) and severe constipation. IBS is a disorder that interferes with the normal functions of the large intestine (colon). Symptoms may include cramps, abdominal pain, bloating, constipation, and/or diarrhea. Zelnorm works by increasing the movement of stools through the bowels.

Litigation:

At the time it was removed from the market, Zelnorm was one of the top 200 most prescribed brand-name medications in the United States, with over 2.6 million prescriptions written during 2006. The IBS drug generated sales of $561 million worldwide in 2006, with $488 million from sales in the United States. This represented a 34% increase in total sales over 2005. Many suspect that the manufacturer's faulure to properly warn of the dangers of Zelnorm placed profits before patient safety.

A recall from marketing of a drug like this is a sign that Zelnorm had dangers that were not previously being told to doctors who were prescribing the drug. If you or a loved one have experienced cardiac problems or had a stroke while you were on Zelnorm, you may be entitled to compensation. Please fill out our contact form and an experienced DrugSettlement.com attorney will contact you for a free and confidential evaluation of your claim.

If you or a member of your family may have been injured as a result of a pharmaceutical drug, please contact the defective drug lawyers at the Law Office of Nix and McIntyre.

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