Rezulin
Rezulin is an anti-hyperglycemic drug that increases insulin sensitivity in skeletal muscle and decreases glucose production in the liver. 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.
There has been some evidence to suggest that the FDA collaborated closely with Warner Lambert in the approval process for Rezulin. Unfavorable reviews were left out of the body of evidence submitted to the FDA advisory panel. 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.
Prior to the withdrawal of Rezulin, the FDA strengthened the liver toxicity warnings on the label and sent a series of letters to physicians recommending regular liver enzyme tests for patients using the drug. Recent studies have indicated that these warnings were ignored.
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