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U.S. Department of Health and Human Services




P00-8                       FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE       Print Media:       301-827-6242
March 21, 2000              
                            Consumer Inquiries:888-INFO-FDA

REZULIN TO BE WITHDRAWN FROM THE MARKET

FDA today asked the manufacturer of Rezulin (troglitazone) -- 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 recent 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.

In March 1999, FDA's Endocrine and Metabolic Drugs Advisory Committee reviewed the status of Rezulin and its risk of liver toxicity and recommended continued availability of this drug in a select group of patients -- patients not well-controlled on other diabetes drugs.

Since then, FDA has continued to actively monitor adverse events associated with Rezulin, as well as Avandia and Actos. After up to nine months of marketing experience with these two newer drugs, it has now become clear that these newer drugs have less risk of severe liver toxicity than Rezulin.

Patients using Rezulin are urged to contact their physicians for information about alternative treatments. Patients should not discontinue taking Rezulin or other treatments for diabetes without discussing alternative therapies with their physicians.

For more information about Rezulin, go to FDA's MedWatch site.

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