Gastroenterology

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Alosetron’s Restrictions Require Pharmacists’ Attention

KEY POINT

The first medication ever to return to the U.S. market after being withdrawn because of safety concerns, alosetron (Lotronex—GlaxoSmithKline) is being reintroduced as a treatment for women with severe diarrhea-predominant irritable bowel syndrome (IBS) who have failed to respond to conventional therapy, whose IBS symptoms are chronic, and in whom other gastrointestinal medical conditions that could explain their symptoms have been ruled out. A fairly straightforward risk-management plan is being implemented as part of FDA’s approval of the product’s return (see Lotronex news release at www.gsk.com/media/archive.htm).