Drug Causing Severe Side Effects Is Withdrawn

Food and Drug Administration (FDA). The drug, alosetron hydrochloride (Lotronex), is the product of Glaxo Wellcome (London, UK).

The company's action followed an analysis by the U.S. Food and Drug Administration (FDA) of reports of serious side effects since the drug's approval in February, including the deaths of five patients. Other side effects that were reported included 49 cases of ischemic colitis and 21 cases of severe constipation. In all, 34 cases resulted in hospitalization.

Following its analysis, the FDA met with Glaxo Wellcome to consider a number of marketing options, including restricting distribution of the drug or market withdrawal. At the conclusion of the meeting, Glaxo informed the FDA that it would voluntarily withdraw the drug. In the meantime, the FDA is advising patients taking the drug to contact their healthcare providers in order to discuss alternative treatments.



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