The FDA pulled the popular diabetes drug, Rezulin, from the market in March 2000. The drug, that had previously won fast-track government approval in 1997, was linked to numerous liver failures and deaths. Warner-Lambert Company, the maker of the drug, had been reaping sales of more than $1.8 billion from Rezulin. At its height, about 300,000 Rezulin prescriptions were sold each month. Warner-Lambert had touted the drug as free of serious side effects. However, the director of the FDA indicated that in comparison to other alternative diabetes treatments, the "continued use of Rezulin now poses an unacceptable risk to patients." The FDA had concluded that at least 90 liver failures including 63 deaths were possibly or probably caused by Rezulin use. The FDA’s senior epidemiologist estimated that some 20 Rezulin users a month were suffering from liver failure.

Complete Text of the FDA Statement (March 21,2000)

The 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 the FDA's request.

The 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 the 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 the 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, the 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, the 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.

What is Rezulin?

What is Type-2 diabetes?

Why is Rezulin a problem?

Why was Rezulin recalled?

How does Rezulin cause liver damage?

When did Warner-Lambert first learn of the Rezulin’s toxicity?

Are there other drugs similar to Rezulin that I can take?

What should I do if I took Rezulin?

Do I have any legal rights?

What kind of information does my lawyer need from me?