Avandia Lawsuits

Avandia is a diabetes drug in the same class as Rezulin, an FDA recalled drug in March 2000. The FDA sent a warning letter on July 17, 2001 saying that Avandia has falsely denied serious risk of congestive heart failure, hepatitis, and liver failure occurring in Avandia users. When Rezulin diabetes drug was recalled it was very controversial but the FDA claimed they were waiting to recall it until a safer alternative was found. Avandia was thought to be safer on the liver, although the FDA claimed Avandia was believed to be safer but still had the risk of causing liver toxicity.

The consumer group Public Citizen never found evidence that Avandia was a safe alternative. Approved on May 25, 1999, Avandia first had label changes made by the FDA on February 8, 2001. The Avandia revisions included warnings of cardiac failure and other cardiac effects, in addition to hepatic risk information. A February 22, 2001 letter was sent to Avandia manufacturer stating all Avandia promotional materials must be revised to include the new risks no later than March 8, 2001, however the manufacturer continued denying the risk existence at major meetings in addition to minimizing them in certain labeling pieces.

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