On March 30, 2007 the U.S. Food and Drug Administration (FDA) announced that Novartis Pharmaceuticals had agreed to the FDA’ request that they voluntarily discontinue marketing and sales of Zelnorm (tegaserod maleate).

According to the FDA, Zelnorm has been associated with an increased risk of serious cardiovascular adverse events (heart problems). In addition to heart problems, risks included ovarian cysts and fainting spells.

Throughout February and March 2007, Novartis reported to FDA the results of a new analysis of 29 short-term (1 - 3 months) randomized, controlled clinical trials of Zelnorm. FDA has concluded, based on these data that for most patients the benefits of this drug no longer outweigh the risks.

FDA is currently advising patients who are using Zelnorm to contact their health care providers to discuss treatment alternatives. Patients who are taking Zelnorm should seek emergency medical care if they experience severe chest pain, shortness of breath, dizziness, sudden onset of weakness or difficulty walking or talking, or other symptoms of a heart attack or stroke.