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JAMA. 2000;284:1640.

	Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings.

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.

The revised labeling states that treatment with the drug should not be started when women are constipated and that the drug is contraindicated in patients with the following conditions: history of chronic or severe constipation or sequelae from constipation; history of intestinal obstruction, stricture, toxic megacolon, gastrointestinal perforation, and/or adhesions; history of ischemic colitis; active diverticulitis; or current (or history of) Crohn disease or ulcerative colitis.

The FDA also requires that the drug . . . [Full Text of this Article]

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