FDA Adds to Black Box Warning on Avandia

Label for Type 2 Diabetes Drug Avandia Revised to Warn That it Increases Heart Attack Risk

The U.S. Food and Drug Administration announced on November 14, 2007 that the manufacturer of Avandia (rosiglitazone), a drug used to treat type 2 diabetes, has agreed to add a new black box warning on the drug's labeling about potential increased risk for heart attacks. People with type 2 diabetes who are at high risk of heart attack should talk with their health care provider about the revised warning as they evaluate treatment options.

Avandia, manufactured by GlaxoSmithKline, was approved in 1999 to control of blood sugar levels in patients with Type 2 diabetes. In May 2007, a New England Journal of Medicine article linked Avandia to elevated risk of heart attack.

The November 2007 addition to Avandia's existing black box warning includes the following statement:

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. (5.2)

The previous warning added to Avandia and Actos emphasized that these types of drugs may worsen heart failure, a condition in which the heart does not adequately pump blood, in some patients. GSK is also developing a Medication Guide for patients to provide additional information about the benefits and risks and safe use of Avandia. To date, no oral anti-diabetes drug has been conclusively shown to reduce cardiovascular risk. The FDA will be requesting that labeling of all approved oral anti-diabetes drugs contain language describing the lack of data showing this benefit.

At the July 2007 joint meeting of FDA's Endocrine and Metabolic Drugs and Drug Safety and Risk Management Advisory Committees, members voted 22-1 to recommend that Avandia stay on the market, pending a review of additional data. The committee also advised that the new black box warning for increased risk of heart attacks should be added to Avandia's drug label.

At this time, FDA has concluded that there isn't enough evidence to indicate that the risks of heart attacks or death are different between Avandia and Actos, a similar oral type 2 diabetes treatments in the same class as Avandia. The FDA has requested that GSK conduct a new long-term study to evaluate the potential cardiovascular risk of Avandia, compared to an active control agent.

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