March 31, 2007Sales of Zelnorm stopped over side effects risk
The manufacturer of the irritable bowel syndrome (IBS) drug Zelnorm has agreed to stop selling the medication at the request of the Food and Drug Administration. The decision to pull Zelnorm from the market came after a number of studies suggested that the drug could increase the risk of heart attack or stroke for patients.
According to the results of 29 studies conducted by the drugmaker Novartis, patients taking Zelnorm experienced heart problems at a rate that was nearly eight times as high as those who were given a placebo. FDA officials decided that this risk of Zelnorm side effects was too high to warrant keeping the drug on the market, and asked Novartis to pull it from the market.
Experts are uncertain as to why Zelnorm may increase the risk of heart attack or stroke. Although doctors are unclear as to how the drug helps to alleviate the symptoms of IBS, they believe that Zelnorm causes wavelike movements in the bowels which promotes the movement of stool. According to the FDA, these wavelike movements may also cause spasms in the arteries, which may be the source of the cardiovascular side effects of Zelnorm.
Although the FDA asked Novartis to discontinue sales of the drug, the agency stopped short of calling for a full Zelnorm recall. Officials with the agency said that they may consider allowing limited sales of the drug to patients who do not respond to other forms of treatment.