FDA TAKES ACTION ON 2 DRUGS

MAY 01, 2007

Drug companies have voluntarily taken tegaserod maleate (Zelnorm) and pergolide off the market at the urging of the FDA. Novartis pulled Zelnorm because clinical trial data indicated a possible link to heart attacks and strokes. The drug was approved by the FDA in 2002 for the short-term treatment of women with irritable bowel syndrome. The product also received FDA approval for the treatment of men and women <65 years of age with chronic idiopathic constipation in August 2004. The FDA said that Zelnorm may be able to return on a limited basis, but only if a group of patients could be identified for whom the benefits outweigh the risks.

The Parkinson's disease drug pergolide, which already carried a black-box warning, was pulled from the market after 2 reports showed that it could cause heart valve damage.

Pergolide is marketed by Valeant Pharmaceuticals International under the trade name Permax and is sold and manufactured as a generic drug by both Par Pharmaceutical Inc and Teva Pharmaceutical Industries Ltd.




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