Drug Warning: Lotronex

Generic name: alosetron hydrochloride

Manufactured and marketed by: GlaxoSmithKline

Purpose: Prescribed to treat irritable bowel syndrome, commonly referred to as IBS.

Side Effects Reported

• As of February 2001, the FDA had received 66 reports of cases of ischemic colitis and an additional 61 reports of cases of severe constipation that may have been linked to Lotronex.
• Some of these patients required surgery and others remain permanently disabled from these side effects.
• Also, according to the FDA, the deaths of 4 patients may be linked to Lotronex.

Industry Report

Lotronex had been voluntarily withdrawn from the market, at the request of the FDA, by GlaxoSmithKline in the year 2000. However, Lotronex has been re-approved and put back on the market in a very limited capacity. The withdrawal came after Lotronex was linked to several reports of harmful side effects. Lotronex has been linked to reports of ischemic colitis and severe constipation. Ischemic colitis is a condition in which serious intestinal damage is caused by a reduced blood flow to the intestines. Ischemic colitis may result in death or the need for surgery in serious cases.

Seeger Weiss is not currently pursuing lawsuits on this drug, but its drug warnings will remain on our radar.

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