Avandia (rosiglitazone) is used by more than 2 million people to treat "type-2" or "adult-onset" diabetes, and is manufactured by GlaxoSmithKline. Avandia was approved in 1999 for treatment of type 2 diabetes, a serious and life threatening disease that affects about 18 to 20 million Americans. Diabetes is a leading cause of coronary heart disease, blindness, kidney failure and limb amputation.

Avandia and Adverse Health Effects

Since the drug was approved, FDA has been monitoring several heart-related adverse events (e.g., fluid retention, edema and congestive heart failure) based on signals seen in previous controlled clinical trials of Avandia alone and in combination with other drugs, and from postmarketing reports. FDA has updated the product's labeling on several occasions to reflect these new data, most recently in 2006. The most recent labeling change for Avandia also included a new warning about a potential increase in heart attacks and heart-related chest pain in some individuals using Avandia.

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Advice for Patients

The FDA is advising patients who are taking Avandia -- especially those who are known to have underlying heart disease or who are at high risk of heart attack -- to talk to their doctor about this new information as they evaluate the available treatment options for their type 2 diabetes.

Pending questions on the safety of Avandia include whether another approved drug (pioglitazone) has less, the same, or greater risks. Furthermore, there is inherent risk associated with switching patients with diabetes from one treatment to another even in the absence of specific risks associated with particular treatments. For these reasons, FDA is not asking GlaxoSmithKline, the drug's sponsor, to take any specific action at this time. FDA is providing this emerging information to prescribers so that they, and their patients, can make individualized treatment decisions.

More Information:

• Long-term Risk of Cardiovascular Events With Avandia (Rosiglitazone) (Journal of the American Medical Association 9/12/07)
• FDA Announcement on "Black Box" Warnings for Diabetes Drugs (8/14/2007)
• FDA Safety Alert on Avandia (5/21/2007)
• New England Journal of Medicine Study on Avandia
• GlaxoSmithKline's Response to the NEJM article
• FDA Information on Avandia