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Pharmacy Focus

FDA Releases New Warning for Avandia

The FDA issued an alert this week regarding a potential safety issue related to rosiglitazone maleate (Avandia).

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 rosiglitazone. However, other published and unpublished data from long-term clinical trials of rosiglitazone provide contradictory evidence about the risk of ischemic cardiovascular events in patients taking rosiglitazone.

The FDA's review of all available data is ongoing, and the agency 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 rosiglitazone label.

According to the FDA, it 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 these reasons, the FDA is providing this emerging information to prescribers so that they and their patients can make individualized treatment decisions.