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Increased Deaths, GI Problems Found with Alosetron


Use of alosetron (Lotrenox—Glaxo Wellcome) has been linked to at least five deaths and several dozen cases of adverse GI effects in reports to FDA. As noted in the mandatory Medication Guide for this product (see ADIL, August 2000 issue), the problems include constipation severe enough to require intestinal surgery (colectomy in some cases) and ischemic colitis. All reported deaths thus far have involved patients with constipation, which can result in obstruction, perforation, impaction, toxic megacolon, and secondary ischemia.