FDA TAKES ACTION ON 2 DRUGS

Published Online: Tuesday, May 1, 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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