Zelnorm Recall
Posted by
Vickye YoungApril 03, 2007 3:19 PMAt the request of the US Food and Drug Administration, Zelnorm (tegaserod maleate), an irritable bowel syndrome drug manufactured by Swiss drugmaker Novartis Pharmaceuticals Corporation, has been recalled.
Approved in 2002 by the FDA, Zelnorm was prescribed to women for short-term treatment of irritable bowel syndrome with constipation, and in 2004 for men and women younger than 65 with chronic constipation. In 2004, a new warning label was added about side effects including diarrhea and colitis. Zelnorm was later linked to statistically significant numbers of adverse side effects, including heart problems, stroke and, in one case, a death.
In late February and early March 2007, Novartis Pharmaceuticals gave the FDA the results of new analyses of 29 clinical studies of Zelnorm for treatment of a variety of gastrointestinal tract conditions; the data from all the studies were combined to assess the chance of side effects on the heart blood vessels.
At the FDA's request, Novartis Pharmaceuticals Corporation has agreed to stop selling Zelnorm. The FDA said doctors who prescribe Zelnorm should work with their patents and transition them to other therapies. An estimated 12 million Americans suffer from painful and disruptive symptoms of irritable bowl syndrome with constipation.