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Lotronex Withdrawal
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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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