The FDA is under fire from Senate members to ban the use of Avandia, the popular diabetes drug from GlaxoSmithKline. It has been speculated that as many as 80,000 heart attacks have been initiated by the use of Avandia. The FDA is reviewing documents and recommends patients continue taking the medicine for the time being.
AVANDIA (rosiglitazone maleate) is an oral antidiabetic agent which increases insulin sensitivity. AVANDIA improves glycemic control while reducing circulating insulin levels.
In 42 clinical studies (average duration 6 months with a total of 14,237 total patients), most of which compared AVANDIA to placebo, AVANDIA was shown to be associated with an increased risk of myocardial ischemic events such as angina or myocardial infarction. Three other studies that compared AVANDIA to other approved oral antidiabetic agents or placebo have not confirmed or excluded this risk. In their entirety, the available data on the risk of myocardial ischemia are inconclusive.
A similar drug, Actos, has been shown to lower glucose as well as Avandia. Actos appears to have a lower risk of causing cardiovascular problems.
In a 342-page report released by the Senate Finance Committee, Glaxo is accused of knowing for several years that Avandia had strong potential to induce heart attacks, but downplayed this scenario to the FDA and the general public.
Sen. Chuck Grassley stated, “FDA officials can try to spin this story, but the simple truth is that drug company emails from two years ago spoke of cardiovascular deaths, and nobody taking the drug was told of the risk until our committee report exposed the information.” In a statement, Glaxo said it stands behind the safety and efficacy of Avandia. The company quoted a public health posting on the FDA’s Web site that said “There are no new FDA conclusions or recommendations about the use of rosiglitazone in the treatment of type 2 diabetes.”