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Avandia Label to Get Heart-Attack Warning
Date:11/14/2007

attacks.

Controversy over Avandia started in May, when a study published in the New England Journal of Medicine, found a 43 percent increased risk of heart attack among patients taking the drug. The study was carried out by Dr. Steven E. Nissen, chairman of the Cleveland Clinic's department of cardiovascular medicine, and his colleague Kathy Wolski. Nissen said he uncovered the risk after poring over data from 42 studies of Avandia.

Both the FDA and GlaxoSmithKline continue to say that the evidence for the risk of heart attack with Avandia is inconclusive.

"Avandia remains a safe and effective medicine for most patients with type 2 diabetes when used appropriately," Dr. Ronald Krall, GlaxoSmithKline's chief medical officer, said in a prepared statement. "Given the severity of this disease and the importance of Avandia in helping patients manage their diabetes, we will continue to work with the FDA to conduct more studies about the safety and benefits of our medicine."

The new warning states: "A meta-analysis of 42 clinical studies (mean duration 6 months; 14,237 total patients), most of which compared Avandia to placebo, showed Avandia to be associated with an increased risk of myocardial ischemic events such as angina or myocardial infarction. Three other studies (mean duration 41 months; 14,067 patients), comparing Avandia to some 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."

The FDA is advising people with type 2 diabetes who have heart disease or are at risk of a heart attack to discuss their use of Avandia with their doctor to evaluate treatment options. The agency is also advising doctors to monitor patients who have cardiac risk and are taking the drug.

In August, Avandia's warning label was changed, to state that the drug and others in its class may wo
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