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Glaxo Wellcome Lotronex

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

FDA's proposal to include black box warning on constipation in alosetron labeling is countered by Glaxo Wellcome at the June 27 FDA Gastronintestinal Drugs Advisory Committee with a proposal for bold, underlined warnings on constipation and ischemic colitis. Glaxo also proposed contraindicating Lotronex in patients with a history of chronic or severe constipation. The drug is indicated for use in women with diarrhea-predominant irritable bowel syndrome, not constipation-predominant IBS or symptoms alternating between the two. Committee members questioned whether approved labeling goes "far enough" in preventing use of the agent by patients with alternating symptoms. The committee recommended that studies be conducted on risk factors, such as smoking and use of oral contraceptives. Several members agreed with FDA that Lotronex should provide a MedGuide, an FDA-approved patient information inser
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