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From the Food and Drug Administration
May 3, 2000

Withdrawal of Troglitazone and Cisapride

Author Affiliations

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Copyright 2000 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.2000American Medical Association

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JAMA. 2000;283(17):2228. doi:10.1001/jama.283.17.2228

The FDA wishes to inform physicians of the removal from the market of troglitazone (Rezulin, Parke-Davis/Warner-Lambert Co, Morris Plains, NJ), a treatment for type 2 diabetes mellitus, and cisapride (Propulsid, Janssen Pharmaceutica Inc, Titusville, NJ), a treatment for severe heartburn.

Troglitazone has been associated with rare but severe liver toxicity since 1997, and close monitoring of liver function of patients using the drug was recommended. A year ago, when it was the only drug of an important class, an FDA advisory committee recommended that troglitazone continue to be available for patients whose disease was not well-controlled by other medications, on the grounds that its benefit to the great majority of patients far outweighed the risk.

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