Washington – The widely used diabetes drug Avandia should stay on the market, government health advisers recommended Monday, saying evidence of a higher risk of heart attack doesn’t merit its removal.
The nonbinding recommendation to the Food and Drug Administration came on a majority vote by the panel. The tally wasn’t immediately available.
“We’re being asked today to take a very draconian action based on studies that have very significant weaknesses and are inadequate for us to make that kind of decision,” said Rebecca Killion, a Bowie, Md., diabetic and the panel’s patient representative.
However, in an earlier 20-3 vote, the panelists said available data show the drug increases heart risks. Panelists said the drug’s warning label should be updated and there should be additional study.
Earlier, Dr. David Graham, an FDA scientist, told the joint panel of experts that the drug’s heart risks, combined with its lack of unique short-term benefits in helping diabetics control blood sugar, meant continued sales were not justified.
Manufacturer GlaxoSmithKline PLC argued that there is no increased risk, citing its own analyses of studies of Avandia, also called rosiglitazone.
The FDA convened the experts to consider whether Avandia should be restricted to select patients and branded with warnings or removed from sale. Previously, the FDA had said information from dozens of studies pointed to an increased risk of heart attack.
The FDA isn’t required to follow the advice of its advisory committees but usually does.
