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FDA Requires Confusing New Warnings on Avandia Labels

The FDA recently ordered a confusing change to the “black box” warning on labels for Avandia, GlaxoSmithKline’s extremely popular oral diabetes medication. Avandia, the brand name for rosiglitazone, was ordered last summer to carry a “black box” warning stating that the drug may cause or worsen heart failure in patients who already have serious heart problems. The new warning adds that Avandia might also be associated with an increased risk of a different problem—heart attacks—or it might not, but no one can tell yet.

The new label essentially says that one study comparing patients who took Avandia to those who took placebos found the Avandia patients had greater risk of heart attack, and that three other studies comparing patients who took Avandia to those who took other diabetes medications showed no increased risk of heart attack. “[W]e have concluded there isn’t enough evidence to indicate that the risk of heart attack is higher for Avandia than other type 2 diabetes treatments,” said Dr. Janet Woodcock, acting director of the FDA’s Center for Drug Evaluation and Research.

Not surprisingly, many consumers find the new label puzzling. “Well, that’s clear as mud,” remarked Dan, a 65-year-old type 2 diabetic in Illinois who has been taking Avandia in combination with other oral diabetes drugs for two years. “It makes no sense to me.”

Fortunately, Dan did exactly what both the FDA and Avandia-maker GlaxoSmithKline recommend: he talked to his doctor. They’ve been working together for several years to control Dan’s diabetes. “He showed me my chart, how my sugars and my A1c have gone down a lot since I’ve been taking my medicine,” said Dan. His doctor noted that Dan did not have heart failure, unusual swelling, or other risk factors that could cause a heart attack, and recommended that he continue taking his Avandia.

If you are taking Avandia and have concerns about your heart health, please talk to your doctor.

Here is Avandia’s new boxed warning:

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.