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From the Food and Drug Administration
October 4, 2000

Important Warning About Alosetron Hydrochloride

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JAMA. 2000;284(13):1640. doi:10.1001/jama.284.13.1640

The FDA has added significant new safety information to the labeling of alosetron hydrochloride (Lotronex, Glaxo Wellcome, Research Triangle Park, NC), a 5-HT3 (serotonin) antagonist indicated for treatment of women with diarrhea-predominant irritable bowel syndrome. The updated labeling highlights information about potentially serious complications of constipation and the risk of ischemic colitis, and specifies that the product is intended for women who have had symptoms that are not attributable to organic disease for at least 3 months.

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