FDA considers lifting safety restrictions on Avandia

Avandia, once the top-selling diabetes drug, had been tied to coronary risks.
Associated Press/File/2010
Avandia, once the top-selling diabetes drug, had been tied to coronary risks.

WASHINGTON — A former blockbuster diabetes pill that was subjected to major safety restrictions in 2010 may be less risky than thought, according to the latest analysis of the much-debated drug Avandia.

The Food and Drug Administration is reviewing a new interpretation of the key study of Avandia’s heart attack risks, which suggests it is as safe as older diabetes drugs. At a highly unusual meeting this week, the FDA will ask a panel of experts to vote on a range of options for the drug, including lifting restrictions on its use.

The positive safety review from Duke University researchers is the latest twist in a years-long debate over Avandia, which has divided experts, cost maker GlaxoSmithKline billions of dollars, and possibly resulted in an unknown number of patient heart attacks.


First approved in 1999, Avandia became the top-selling diabetes pill in the world by 2006 with sales of $3.4 billion. But prescriptions plummeted the following year after an analysis of dozens of studies suggested Avandia could raise the risk of heart attack.

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For three years the FDA struggled to answer a seemingly simple question: Does Avandia increase the risk for heart attacks? A definitive answer has not been reached, in part because patients with diabetes are already predisposed to heart problems. That makes it extremely difficult to tell which heart attacks are drug-related.

In 2010 the FDA decided to restrict the drug’s use to only rare cases. Regulators in Europe banned the drug outright.

FDA critics have speculated that the real purpose of this week’s meeting is to vindicate FDA officials who kept Avandia on the market for so many years.

‘‘It’s the wrong reason to take a regulatory action,’’ said Dr. Steven Nissen of the Cleveland Clinic, who wrote the 2007 analysis that first raised concerns about Avandia. ‘‘You want to take a regulatory action because it’s going to benefit patients. I don’t see how patients could possibly benefit from lifting these regulatory restrictions.’’


FDA officials said Wednesday and Thursday’s meeting was prompted by a new analysis of the key study of Avandia’s heart risks, known as RECORD. The study followed 4,400 patients and tracked rates of heart attack, hospitalization, and death for six years.

The results were first reported in 2009 and medical experts have been debating their legitimacy ever since.

At the last Avandia panel meeting in 2010, FDA leadership generally backed RECORD’s findings that Avandia appeared as safe as other standard diabetes drugs. But FDA scientists said the study was unreliable because of underreported heart attacks and other design flaws. Because of that disagreement the FDA asked Glaxo to obtain an independent analysis by an outside party.

The new analysis by the Duke Clinical Research Institute generally supports Glaxo’s original findings.

Even if the latest reassessment clears Avandia’s safety record, the impact could be minimal. Glaxo executives say they believe the drug should remain available for patients with hard-to-treat diabetes, but the company has no plans to resume advertising for it.