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U.S. Department of Health and Human Services


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Avandia (rosiglitazone)

Audience: Endocrinologists, other healthcare professionals, consumers

[Posted 05/21/2007] FDA informed healthcare professionals of a potential safety issue related to Avandia (rosiglitazone). An on-going analysis of safety data for the treatment of type 2 diabetes mellitus using Avandia showed differing rates of ischemic cardiovascular events including heart attack or heart-related adverse events, some fatal, relative to other drugs used to treat diabetes mellitus. The clinical studies reviewed to date vary with respect to their populations, treatment regimens, and length of follow-up. Based on these data, the risk of ischemic cardiovascular events due to Avandia remain unclear. Prescribers should continue to carefully make individualized treatment decisions for patients with diabetes mellitus.

[May 21, 2007 - Healthcare Professional Information Sheet - FDA]
[May 21, 2007 - News Release - FDA]
[April 2007 - Prescribing Information - GlaxoSmithKline]

Previous MedWatch Alerts:

[February 20, 2007]