Avandia Label to Get Heart-Attack Warning

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 anti-diabetic 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 worsen heart failure -- a condition in which the heart does not adequately pump blood -- in some patients. The association between Avandia and increased risk for heart failure has been known since 1999, when the drug was first approved.

Woodcock noted that Avandia and the other oral anti-diabetes drugs, called thiazolidinediones, have not been shown to prevent cardiovascular risk as a byproduct of reducing blood sugar.

In light of this, the FDA is asking all manufacturers of approved oral anti-diabetes drugs to include a statement on their label saying that there is no data that the drugs have the ability to protect the heart.

More information

For more on diabetes drugs, visit the U.S. Food and Drug Administration.

SOURCES: Steven E. Nissen, M.D., chairman, department of cardiovascular medicine, Cleveland Clinic; Nov. 14, 2007, teleconference with Janet Woodcock, M.D., acting director, Center for Drug Evaluation and Research, U.S. Food and Drug Administration; Nov. 14, 2007, news release, GlaxoSmithKline, Philadelphia