Health Buzz: FDA Slaps New Restrictions on Diabetes Drug Avandia

September 23, 2010 RSS Feed Print

Diabetes Drug Avandia: Still Available, but With Restrictions

The diabetes drug Avandia will remain on the market, but will only be available to select patients, the Food and Drug Administration announced today. The restrictions come amid concerns that the drug increases the risk of cardiovascular problems, like a heart attack or stroke. Under the new rules, Avandia can only be prescribed to patients who can't get blood sugar levels under control with other medications. As for the 600,000 Americans currently taking the drug, they can continue, but like new patients, they'll have to sign a consent form indicating they're aware of the potential risks. Use of two other diabetes drugs—Avandamet and Avandaryl—will also be restricted; both contain rosiglitazone, the active ingredient in Avandia. Meanwhile, the European Medicines Agency—the FDA's European counterpart—said today that it will no longer market Avandia. The FDA and EMA made their decisions based on the same data, The Wall Street Journal reports. The new rules will not take effect in either country for several months.

In July, an FDA panel of outside experts voted against banning Avandia, leaving many to wonder why a drug that seems to raise the risk of heart problems should continue to be a treatment option.

What Now for the Diabetes Drug Avandia?

For the past three years, the evidence against Avandia has been building, writes U.S. News's Deborah Kotz. A 2007 study found a 43 percent increase in heart attacks and a 64 percent spike in heart disease deaths in diabetics taking Avandia (meaning the absolute risk of a heart attack of cardiovascular death would rise from roughly 2 percent a year to 3 percent) compared to those who took other drugs. A later study by an FDA researcher reached similar conclusions. The manufacturer's own safety study revealed no increased heart risk, but the FDA found that the study had wrongly excluded a number of patients who had heart complications or who died during the study. If they had been included, Avandia would have been deemed heart damaging. Manufacturer GlaxoSmithKline also appears to have deliberately hid safety data, according to internal company documents released by the Senate, leading the panel of experts to question the company's trustworthiness.

Yet even with all the growing evidence—and the negative press and growing calls for Avandia to be yanked from the market—the FDA panel of outside experts voted against a ban. Only 12 of the 33 members voted to withdraw Avandia, while an additional 10 voted to allow the drug to be prescribed only with severe limitations such as requiring physicians and patients to be educated about its risks. The panel, like the FDA itself, was largely divided over what to make of Avandia's potential health risks. The problem? Most of the panel members weren't satisfied with the quality of the studies conducted since the drug was approved 11 years ago, and some said they couldn't conclude from the evidence that Avandia was any riskier than Actos, its major rival in the same drug family. During the hearing, one member Lewis Nelson, an associate professor of emergency medicine at New York University School of Medicine, wondered "why there isn't better data at this point"—a notion seconded by the others. [Read more: What Now for the Diabetes Drug Avandia?]

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