FDA considers Avandia restrictions
WASHINGTON – Faced with conflicting and less-than-conclusive scientific evidence, a majority of a Food and Drug Administration advisory panel voted Wednesday to recommend that the controversial diabetes drug Avandia remain on the market – but with tighter supervision and warnings about the danger of heart attacks.
Advisory recommendations are not binding, and the FDA is expected to take at least several weeks to consider its response, but the panel’s expression of increased concern is likely to further reduce doctors’ reliance on what was once the prescription of choice for treating Type 2 diabetes.
Cleveland Clinic cardiologist Steven Nissen, whose 2007 analysis of multiple studies of Avandia touched off much of the controversy over the drug, said after the panel’s vote, “They gave the leadership of FDA enough ammunition to withdraw the drug if they want to withdraw it.”
Reflecting the difficulty of balancing potential risks and benefits for individual patients, 12 members of the 33-member panel voted to recommend removing Avandia from the market, while 10 panelists voted to keep Avandia on the market under close supervision with an FDA-approved risk-benefit plan, seven voted to permit continued marketing but with stronger label warnings, and three favored the status quo. (One member abstained.)
Several panelists said they were persuaded to vote in favor of limiting or eliminating Avandia because another drug, Actos, works as well but has not shown as many negative side effects.
The votes by a majority of the panel’s members essentially affirmed a recommendation by a similar panel in 2007 that concluded Avandia could increase the risk of heart attack but nonetheless should remain on the market. But Wednesday’s vote was closer; the 2007 panel approved keeping the drug on the market 22-1.
Also known as rosiglitazone, Avandia is a pill used to control blood sugar by making the body more sensitive to insulin. Unlike patients with Type 1 or juvenile diabetes, patients with Type 2 – often older people – continue to produce insulin but their bodies do not use it effectively.
Reliance on Avandia has dropped sharply in recent years as evidence began to accumulate linking it to increased risk of heart attack, but hundreds of thousands of patients continue to take it.
At the peak of its popularity in 2006, 13 million prescriptions were written, according to IMS Health, a pharmaceutical market research company. By 2009, the number had declined to about 2.6 million, the firm said.
Still, the drug’s maker, GlaxoSmithKline, said some 550,000 Americans took medications containing Avandia in the past year.
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