Drugs & Medical Devices Law

Has the FDA issued any safety alerts regarding Avandia?

Yes.  The FDA has issued safety alerts about the use, and side effects of using, Avandia.  In addition, the FDA has conducted long investigations into its safety.

FDA ALERT #1: 5/21/2007, updated 11/19/2007:  The FDA added a new warning about the risk of myocardial ischemia to the boxed warning for Avandia, for treatment of Type 2 Diabetes.

FDA ALERT #2: 8/14/2007: The FDA issued important revisions to the full prescribing information (labeling) highlighting increased risks of congestive heart failure associated with rosiglitazone.

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