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  Vol. 162 No. 1, January 14, 2002 TABLE OF CONTENTS
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  Editor's Correspondence
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Lotronex Withdrawal

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

I read with interest the article by Camilleri et al1 on alosetron in women with diarrhea-predominant irritable bowel syndrome. However, the authors failed to address one important issue. While the side effects reported in this trial were relatively mild and were primarily limited to constipation, the manufacturer, Glaxo Wellcome, voluntarily withdrew the drug from the market in November 2000 following reports of more serious adverse events. The drug had been marketed as Lotronex and had been approved by the Food and Drug Administration (FDA) in February 2000. The action on the part of Glaxo Wellcome occurred subsequent to the FDA's analysis of postmarketing adverse reactions. As of November 2000, the FDA had received 70 reports of serious adverse effects, including 49 cases of ischemic colitis and 21 cases of severe constipation resulting in severely obstructed or ruptured bowels. Of these 70 cases, 34 required hospitalization, 10 required surgery, and 3 . . . [Full Text of this Article]







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