DOCTOR'S VIEW ARCHIVE

Rezulin Withdrawn From Market Warning

Rezulin is the brand name for a drug called troglitazone and has been used in patients with type II diabetes to help lower and control blood sugars that are not controlled by insulin or by other oral anti-diabetic medications.

Because of increasing numbers of reports of patients who were taking Rezulin that developed serious liver toxicity, the Federal Drug Administration (FDA) has requested that the manufacturer, Parke-Davis/Warner-Lambert, withdraw the drug from the market. Parke-Davis/Warner-Lambert has agreed to implement an immediate withdrawal program.

The actual announcement by the FDA follows. Please note especially the last paragraph which reads "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."

-- Medical Editor, MedicineNet.com


March 21, 2000 WASHINGTON, D.C. --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 drug's 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.


Last Editorial Review: 4/5/2002



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