Zelnorm Recalled

Christina Cole

Contributor

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Novartis Pharmaceuticals has voluntarily agreed to the FDA's request that they discontinue the marketing and sales of Zelnorm (tegaserod maleate).

The FDA's request was based on new information of an increased risk of serious cardiovascular adverse events, including heart attack, chest pain and stroke associated with the use of Zelnorm. Based on this information, the FDA decided that the overall health risk versus the benefit for the drug is unfavorable to continue on the market.

Zelnorm is a prescription drug approved short term, for women who suffer from irritable syndrome with constipation and for patients that are younger than 65 years with chronic constipation.

In February and March of 2007, Novartis Pharmaceuticals, gave the FDA results of new analyses from 29 completed clinical studies that used Zelnorm for treatment of various gastrointestinal tract conditions. The data was combined to weight the chance and of side effects on blood vessels and the heart.

In each study, patients were assigned at random to either Zelnorm or a sugar pill they thought was Zelnorm. These 29 studies included 11,614 patients treated with Zelnorm and 7,031 treated with a sugar pill. The average age of patients in these studies was 43 years and most patients--88%--were women.

The number of patients who suffered a heart attack, stroke or severe heart chest pain that can turn into a heart attack was small. However, patients treated with Zelnorm had a higher chance of having any of these serious and life-threatening side effects than did those who were treated with a sugar pill.

Thirteen patients treated with Zelnorm (0.1%) had serious and life-threatening cardiovascular side effects; among these, four patients had a heart attack (one died), six had a type of severe heart chest pain which can quickly turn into a heart attack, and three had a stroke. Among the patients taking the sugar pill, only one (or 0.01%) had symptoms suggesting the beginning of a stroke that went away without complication.