Diabetes Drug Linked to Heart Disease

The U.S. Food and Drug Administration (FDA) has issued a Safety Alert on the diabetes drug Avandia and its links to heart risks. The alert was issued shortly after a study published in the New England Journal of Medicine (NEJM) suggested a link between use of Avandia and an increased risk of heart disease and heart attack. The NEJM article concludes that "patients and providers should consider the potential for serious adverse cardiovascular effects of treatment with rosiglitazone [Avandia] for type 2 diabetes." Avandia is used by more than 2 million people to treat "type-2" or "adult-onset" diabetes, and is manufactured by GlaxoSmithKline.

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.

• FDA Safety Alert
• Read the New England Journal of Medicine Study (NEJM)
• GlaxoSmithKline's Response to the NEJM article
• NY Times: Study Cites Safety Questions About Diabetes Drug
• FDA Patient Information Sheet: Avandia
• Avandia and the Law (FindLaw)