Associated Press
WASHINGTON -- A majority of federal health experts voted Wednesday to keep the controversial diabetes pill Avandia on the market despite evidence that it increases the risk of heart attack.
A panel of Food and Drug Administration advisers voted 20-12 against withdrawing GlaxoSmithKline's once-blockbuster drug. Panelists who voted to keep the drug on the market were split between several options, including adding new warning labels and restricting use of the drug.
The vote marks a win for British drugmaker Glaxo, which has been battered in the press and on Capitol Hill for its the handling of the drug.
Glaxo's North American headquarters is in Durham's Research Triangle Park, where the company employs about 5,000 workers.
The FDA is not required to follow the advice of its panelists, though it usually does. Officials said they would review the meeting transcript and make a decision on Avandia as soon as possible.
The vote also came despite an earlier ruling by the panel that Avandia appears to increase heart attack risk compared with other diabetes treatments. The panel voted 21-4 that Avandia is more likely to cause heart attack than its closest competitor Actos. Eight panelists said there was not enough information to make a decision.
Ultimately though, panelists said the dozens of contradictory studies of Avandia didn't show strong enough evidence to justify removing a drug used by hundreds of thousands of patients.
"I would be concerned about the precedent that would be set to have this quality of data sufficient to remove a drug," said John Teerlink of the University of San Francisco.
The agency convened the two-day panel meeting to help untangle reams of conflicting data over Avandia.
The FDA has been down this road before. Three years ago a similar FDA panel voted to keep Avandia on the market and the FDA responded by adding bolder warning labels to the drug.
