Was the FDA Negligent in Overseeing the Diabetes Drug, Avandia®?
WASHINGTON, DC — June 22, 2007 —The Food and Drug Administration (FDA) may have been too hasty in approving the diabetes drug, Avandia®, and negligent in issuing timely warnings about its safety, according to some participants at a recent hearing before the House Oversight and Government Reform Committee. The hearing was called after a negative report about Avandia® was published in the New England Journal of Medicine. A meta–analysis of 42 studies, the article said that compared to patients who took fake pills or placebos, diabetics using Avandia® were 43 percent more likely to have heart attacks (N Engl J Med., 2007 Jun 14; 356(24): 2457–71). The FDA approved Avandia® (rosiglitazone) in 1999 to lower blood sugar levels in patients with type 2 diabetes, a disease that affects over 17 million Americans. When deciding whether or not Avandia® sales should go forward, an FDA medical reviewer warned that the drug may have a “deleterious long–term effect on the heart” and recommended a post
