Diabetes Drug Avandia Gets Pass From FDA Panel

Avandia

hide captionAvandia got a pass from an FDA advisory panel which recommended the diabetes drug stay on the market despite concerns that it raises heart-attack rates.

Paul Sakuma/AP

An advisory panel to the Food and Drug Administration refused to recommend that the agency order GlaxoSmithkline to take Avandia, the company's controversial diabetes drug, off the market.

Avandia has received heavy criticism from some experts who claim it adds to mortality and greater illness among patients who receive it because it increases their heart-attack rate.

It's a complex situation, however. Not least among the complications is the fact that diabetes is a significant cause of heart attacks in its own right.

Richard Knox reported on the FDA advisory panel's decision in the network's newscast:

RICHARD: The vote came after the panel reviewed dozens of studies on Avandia. Over and over again, the 33 members of the advisory panel complained that even though the drug has been on the market for 10 years, there's still not very good evidence on its safety.

Most of the panel agreed that it causes more heart attacks than other drugs for diabetes, but said the evidence is inconclusive.

In the end, a dozen panel members voted to take the drug off the market. Twenty said it should remain available, but most of those called for restrictions on its use. There was one abstention.

Doctors write a million prescriptions a year for Avandia. That translates to several hundred thousand patients.

FDA officials usually follow the advice of their advisory panels, but not always.

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