Litigation

The FDA approved Rezulin in 1997 to treat Type 2 diabetes (adult-onset). Rezulin, also known as troglitazone, was manufactured and distributed by Parke-Davis, a Warner Lambert Company. It was recalled in March 2000 because of a risk of liver failure. Warner Lambert continues to maintain that the benefits of the drug outweigh its potential risks.

Approval Process

There has been some evidence to suggest that the FDA collaborated closely with Warner Lambert in the approval process for Rezulin. An FDA medical reviewer was let go after giving the drug an unfavorable review. His review was left out of the body of evidence submitted to the FDA advisory panel. Rezulin was approved in half the usual time it takes for drug approval.

Only eight months after the drug was approved, reports of liver toxicity began filtering in to the FDA and senior officials who had been involved in the approval process began to call for its withdrawal. Unfortunately, it took another two years before the FDA finally recalled Rezulin.

FDA Strengthens Warnings

In the interim two years, the FDA attempted to keep the drug on the market by strengthening the liver toxicity warnings on the label and sending a series of letters to physicians recommending regular liver enzyme tests for patients using the drug. Label warnings were strengthened four times before the FDA abandoned the drug and recalled Rezulin. Recent studies have indicated that physicians ignored these warnings.

In August 2000 a federal investigation was launched to review the FDA's approval process and slow withdrawal of Rezulin.

If you or someone you know has suffered injuries as a result of Rezulin, contact an attorney to discuss your legal rights.

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