Irritable Bowel Drug Lotronex Yanked By FDA

Alosetron (Lotronex) was approved for marketing by the FDA in February, 2000, but was withdrawn from the market in November, 2000, because of serious, life-threatening, gastrointestinal side effects. In June 2002, it was approved again by the FDA for marketing but in a restricted manner as part of a drug company-sponsored program for managing the risks associated with treatment. Use of alosetron is allowed only among women with severe, diarrhea-predominant, irritable bowel syndrome (IBS) who have failed to respond to conventional treatment for IBS.

The original official FDA statement issued when alosetron was originally withdrawn is below.

-- Medical Editor,

November 28, 2000--GLAXO WELLCOME DECIDES TO WITHDRAW LOTRONEX FROM THE MARKET Glaxo Wellcome, of Research Triangle Park, NC, has informed FDA that it will voluntarily withdraw Lotronex (alosetron hydrochloride) tablets from the market. Lotronex is a prescription medication approved to treat Irritable Bowel Syndrome(IBS) in women. The FDA is advising patients taking Lotronex to contact their healthcare providers to discuss treatment alternatives.

The company's action follows a meeting held earlier today with the Food and Drug Administration (FDA) where the agency discussed with Glaxo Wellcome risk management options that included restricting the distribution of the drug or marketing withdrawal.

Today's action follows FDA analyses of the post-marketing reports of serious adverse events, which included 5 reports of death in patients taking Lotronex.