FDA TAKES ACTION ON 2 DRUGS

Pharmacy Times, Volume 0, 0

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 possiblelink to heart attacks and strokes. The drug was approved by theFDA in 2002 for the short-term treatment of women with irritablebowel syndrome. The product also received FDA approval for thetreatment of men and women <65 years of age with chronic idiopathicconstipation in August 2004. The FDA said that Zelnorm maybe able to return on a limited basis, but only if a group of patientscould be identified for whom the benefits outweigh the risks.

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

Pergolide is marketed by Valeant Pharmaceuticals Internationalunder the trade name Permax and is sold and manufactured as ageneric drug by both Par Pharmaceutical Inc and TevaPharmaceutical Industries Ltd.