Zelnorm Recall
The IBS Drug Zelnorm and Heart Problems
In March 2007, the Food and Drug Administration asked Novartis Pharmaceuticals to stop sales and marketing of its irritable bowel syndrome drug Zelnorm (tegaserod maleate) due to the increased risk of Zelnorm heart attacks, strokes and other cardiovascular side effects.
Data from 29 clinical studies with more than 18,000 patients showed that patients taking Zelnorm were eight times as likely to have heart attacks and strokes compared with those taking placebos.
Zelnorm won FDA approval in 2002 for the short-term treatment of women under the age of 65 who had irritable bowel syndrome, abdominal discomfort, constipation and bloating. Two years after this initial approval, the agency widened the range of Zelnorm patients by giving doctors the OK to prescribe Zelnorm to men, to patients 65 and older and to those suffering from severe diarrhea.
FDA forces Zelnorm withdrawal
In 2005, the number of prescriptions written for Zelnorm topped 2 million in the U.S. Although Zelnorm was initially rejected by the FDA, the risk of Zelnorm side effects was not enough to keep it from going on the market in 2002.
The consumer advocacy group Public Citizen was highly critical of the FDA's controversial decision. “Once again, the FDA has approved a drug with marginal effectiveness in the face of serious questions about its safety—putting at risk the millions of people who have already used it,” said Dr. Sidney Wolfe, head of Public Citizen’s Health Research Group.
When information about the cardiovascular side effects of Zelnorm emerged in February 2007, Novartis sought to downplay their seriousness. But the FDA insisted that the company halt marketing and sales of the drug on March 28, 2007.
Benefits outweighed by risks
