Zelnorm, Drug for Irritable Bowel Syndrome, Withdrawn

The FDA announced Friday that Novartis Pharmaceuticals has agreed to stop marketing Zelnorm (tegaserod), used to treat irritable bowel syndrome, after a recent safety analysis found an increased risk for serious cardiovascular events.

Zelnorm was approved for short-term treatment of women with irritable bowel syndrome whose primary symptom is constipation and for men and women younger than 65 with chronic constipation.

An analysis of 29 placebo-controlled clinical trials comprising over 18,000 patients conducted by Novartis found 0.1% of patients taking Zelnorm showed evidence of a serious cardiovascular event, compared with 0.01% taking a placebo. The FDA concluded that, for most patients, the benefits of Zelnorm no longer outweigh the risks. The agency is working with the manufacturer to keep the drug available for those who have no other treatment options.