The FDA asked the manufacturer of Rezulin, (troglitazone) Pfizer, a drug used to treat type 2 diabetes mellitus, to remove the product from the market. The drug's manufacturer, Parke-Davis/Warner-Lambert, has agreed to FDA's request.

FDA took this action after its review of safety data on Rezulin and two similar drugs, rosiglitazone (Avandia) and pioglitazone (Actos), showed that Rezulin is more toxic to the liver than the other two drugs. Data to date show that Avandia and Actos, both approved in the past year, offer the same benefits as Rezulin without the same risk.

"When considered as a whole, the pre-marketing clinical data and post-marketing safety data from Rezulin as compared to similar, alternative diabetes drugs indicate that continued use of Rezulin now poses an unacceptable risk to patients," said Dr. Janet Woodcock, Director of FDA's Center for Drug Evaluation and Research. "We are now confident that patients have safer alternatives in this important class of diabetes drugs," she added.

Severe liver toxicity has been known to occur with Rezulin since 1997. In consultation with FDA, Parke-Davis has strengthened the drugís labeling several times and has recommended close monitoring of liver function in patients taking Rezulin.

Rezulin Links

Pfizer will reimburse patients for their out-of-pocket expenses for unused supplies of Rezulin® (more)

More than 2,000 suits involving Rezulin have been filed in federal and state courts involving approximately 5,100 Rezulin users." (more)

Serious Liver Injury: Leading Reason for Drug Removals

(American Diabetes Association) What You Should Know About the Market Withdrawal of Rezulin (Troglitazone), a Drug for Type 2 Diabetes (more)

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