GlaxoSmithKline's drug Avandia should stay on the market, federal health experts voted Wednesday, but the controversial diabetes pill should be subject to new restrictions due to risky heart side effects.
A panel of Food and Drug Administration advisers voted 20-12 to keep the once blockbuster pill available for diabetics. But 10 panelists also called for limiting who can receive and prescribe the much-debated medication.
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.
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.
"In terms of what has changed since 2007, I think the totality of evidence is much stronger," said panelist Clifford Rosen of the Maine Medical Research Institute. "It's still not absolute but it's stronger."
Despite the vote on Avandia's heart risks, panelists didn't reach a firm conclusion on whether Avandia is more likely to cause death than older drugs. Twenty panelists said it did not appear to cause death, while 12 said they didn't know. Only one panelist concluded the drug leads to death.
The panel's vote to keep Avandia on the market is a vote of confidence in FDA leadership, who have been criticized by some members of Congress for not pulling the drug earlier.
Minutes before the final vote on Avandia, the FDA's director for new drugs emphasized the high bar needed to pull a previously approved drug from the market.
"The two that have been withdrawn for cardiovascular concerns — Vioxx and Zelnorm — showed three-, four- or five-fold increase," said John Jenkins "That's the background of where we stand in terms of increased risk of very rare events."
The FDA first approved Avandia in 1999, and it quickly became the top-selling diabetes pill in the world. U.S. sales have plummeted from $2.2 billion in 2006 to $520 million last year as safety concerns swirled around the drug.
Diabetes patients face considerably elevated heart disease risks, so the 2007 study in the New England Journal of Medicine about problems with Avandia was enough to make doctors switch patients to other therapies. The American Diabetes Association even issued a warning back then, urging patients taking Avandia to talk to their doctors.
"We stopped prescribing it over the last couple of years because of the cardiovascular risks and because there was an alternative in the same class of drugs, one that works chemically in the same way, that has not been shown to have cardiovascular risks," said Dr. Brendan O'Malley, medical director of the Diabetes and Endocrinology Institute at University Community Hospital in Tampa.
"That drug is Actos. So it's a no-brainer to say, let's go to Actos and not wait until they take another look at the safety of Avandia."
Still, he said, some patients prefer Avandia and have refused to go off it.
"We have a few patients, no more than a dozen, who have continued to take Avandia even though we tell them about the risks and that there is an alternative. But some patients will say, 'I've never felt better in my life' and they don't want to switch. It's very good at controlling blood sugars."
Like other medical experts, O'Malley's major piece of advice for patients still taking Avandia is this: "Don't stop your medication without talking with your doctor and discussing alternatives."
Times medical writer Irene Maher contributed to this report from the Associated Press.