Avandia

FDA ALERT [5/21/2007]: FDA is aware of a potential safety issue related to rosiglitazone maleate. Safety data from a pooled analysis of controlled clinical trials have shown a significant increase in the risk of heart attack and heart-related deaths in patients taking Avandia. However, other published and unpublished data from long-term clinical trials of Avandia provide contradictory evidence about the risk of ischemic cardiovascular events in patients taking Avandia. FDA�s review of all available data is ongoing. FDA has not confirmed the clinical significance of the reported increased risk of ischemic cardiovascular events in the context of other studies. Myocardial ischemic events are currently described in the WARNINGS section of the rosiglitzsone label. FDA does not know whether the other approved medication in the same pharmacologic class or other oral drugs for treating type 2 diabetes have less, the same, or greater risks. Switching diabetic patients to other therapies also confers its own risks. For those reasons, FDA is providing this emerging information to prescribers so that they and their patients can make individualized treatment decisions. This information reflects FDA�s current analysis of available data concerning this drug. Posting this information does not mean that FDA has concluded there is a causal relationship between the drug product and the emerging drug safety issue. Nor does it mean that FDA is advising health care professionals to discontinue prescribing the product. FDA is considering, but has not reached a conclusion about, whether this information warrants any regulatory action. FDA intends to update this sheet when additional information or analyses become available.

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