Lotronex Withdrawn from the Market

Lotronex (alosetron hydrochloride, a Glaxo Wellcome product) was initially approved by the FDA on February 9, 2000 for the treatment of Irritable Bowel Syndrome (IBS). IBS is a common and debilitating digestive disorder that afflicts an estimated 15% of the U.S. population, mostly women. IBS causes lower abdominal pain and discomfort and irregular bowel habits such as diarrhea or constipation. Lotronex, a potential billion- dollar-drug, was approved only for women with diarrhea predominant IBS.

Between approval and June 1, 2000 the FDA received seven reports of serious complications of constipation and reports of . These resulted in hospitalizations, and surgical procedures.

Last April the FDA warned the company about unsubstantiated claims of benefit and a sales brochure that buried important risk information.

On November 28, 2000 Glaxo announced that it would voluntarily withdraw Lotronex from the market.

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