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Withdrawal of Troglitazone and Cisapride
JAMA. 2000;283:2228.
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| Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings. |
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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.
The FDA concurred while awaiting postmarketing experience with two subsequently approved drugs for type 2 diabetes mellitus, rosiglitazone (Avandia, SmithKline Beecham Pharmaceuticals, Philadelphia) and pioglitazone (Actos, Takeda Pharmaceuticals America Inc and Eli Lilly, Indianapolis). When . . . [Full Text of this Article]
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