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FDA Panel Recommends More Avandia Restrictions

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Avandia may be allowed to stay on the market after all, following recommendations made yesterday by a Food & Drug Administration (FDA) advisory panel. The panel voted that while sales of the controversial diabetes drug should be restricted, Avandia should be allowed to stay on the market.

Avandia was the biggest selling diabetes drug in the world, until 2007 when a Cleveland Clinic study raised questions about its heart risks. The study, conducted by Dr. Stephen Nissan, showed patients taking Avandia had a 43-percent higher risk of having a heart attack. The drug’s label has borne a black box warning – the FDA’s most serious safety alert – regarding its heart attack risk since November of that year.

Last month, Nissan released a follow-up to that study, which found an increased heart attack risk of 28 percent. The update was among the evidence presented to the FDA advisory panel.

Also considered by the panel was a study conducted by Dr. David Graham, an FDA researcher. That study, which involved 227,500 Medicare patients, found that those who took Avandia were 27 percent more likely to suffer a stroke, 25 percent more likely to develop heart failure and 14 percent more likely to die compared with those who took another drug called Actos.

During the two-day advisory panel meeting, Graham was also highly critical of an Avandia study called RECORD, which was funded by GlaxoSmithKline, the drug’s maker. You can’t trust it, and if we do trust it, we’re engaging in the willing suspension of disbelief,” he said. Graham also characterized RECORD as “garbage”.

RECORD didn’t show an increased heart attack risk as other Avandia studies have. Glaxo, which released RECORD in 2009, used it to tout Avandia’s safety.

In the end, 12 of the advisory panel’s 33 members voted that Avandia should be withdrawn; 10 voted that its sales should be restricted and the warnings on its label enhanced; 7 voted only to support enhanced warnings on the drug’s label; and 3 voted that the drug should continue to be sold with its present warnings unchanged.

The votes came at the end of a two-day meeting where GlaxoSmithKline, Avandia’s maker faced tough criticism for the way it handled the drug and its cardiovascular risks.

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