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March 22, 2000

Severe Liver Toxicity Prompts Withdrawal of Rezulin from the Market

Houston, TX (SafetyAlerts) - Parke-Davis owner of Warner-Lambert has agreed to a request by the FDA to remove Rezulin (troglitazone) – a drug used to treat type 2 diabetes mellitus –  from the market.

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.

Severe liver toxicity has been known to occur with Rezulin since 1997.

“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.

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.

Notice of this product warning was sent via email to SafeMail subscribers March 22, 2000.

Selected Recent Recalls

Health Professional:

Did you know?
During 2000 there were over
1050 products recalled in the United
States for safety reasons!

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