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News From the Food and Drug Administration
August 14, 2002

Limited Approval for Lotronex

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JAMA. 2002;288(6):688. doi:10.1001/jama.288.6.688-JFD20008-2-1

The FDA has authorized limited marketing of alosetron hydrochloride (Lotronex, GlaxoSmithKline, Research Triangle Park, NC), a previously approved drug for the treatment of irritable bowel syndrome (IBS). The product was withdrawn in November 2000 following reports of serious and life-threatening cases of ischemic colitis and complications of constipation, including deaths.

The FDA's approval narrows the original indication to use only in patients with severe diarrhea-predominant IBS, which includes diarrhea and one or more of the following: frequent and severe abdominal pain/discomfort; frequent bowel urgency or fecal incontinence; and disability or restriction of daily activities due to IBS. In addition, such patients must have chronic IBS symptoms (generally lasting 6 months or longer); had anatomic or biochemical abnormalities of the gastrointestinal tract excluded; and failed to respond to conventional therapy.