Reports of Liver DamageRezulin (troglitazone) is a member of a class of drugs known as thiazolidinediones, which have been linked to liver and cardiovascular issues. Rezulin labels warn of increased risk of rare but serious liver problems.
Rezulin is used to treat type 2 Diabetes, sometimes in conjunction with insulin. It was initially approved in 1997.
(March 21, 2000) 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.
If you or a family member have used Rezulin and have suffered any side effects such as liver damage, you may be entitled to compensation.