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 recommended limiting who can receive and prescribe the much-debated medication.
The vote marks a tough win for British drug maker Glaxo, which is facing thousands of lawsuits from patients who say Avandia caused their heart attacks or strokes. While the company may fare better in court due to the panel ruling, sales of Avandia are likely to shrink to minuscule levels.
The FDA is not required to follow the advice of its panelists, although it usually does. Officials said they would review the meeting transcript and make a decision on Avandia as soon as possible.
The vote came despite an earlier ruling by the panel that Avandia appears to increase heart attack risk compared with other diabetes treatments, underscoring the often contradictory evidence for and against the drug.
Ultimately, though, panelists said the dozens of contradictory studies of Avandia did not show strong enough evidence to justify removing a drug used by hundreds of thousands of patients.
"I didn't want to take away a drug without definitive evidence that it was bad for those few patients who need it," said the University of Missouri's Lamont Weide, who voted to leave the drug on the market with new restrictions.
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 panellist Clifford Rosen of the Maine Medical Research Institute. "It's still not absolute, but it's stronger. Clearly there is a signal."
Despite the vote on Avandia's heart risks, panelists did not reach a firm conclusion whether Avandia is more likely to cause death than older drugs.
The panel vote to keep Avandia on the market would appear to support FDA leaders, who have been criticised by some members of Congress for not pulling the drug.
But late Wednesday those critics were already questioning the legitimacy of the meeting.
"The result of the advisory committee vote is gravely disappointing and raises serious questions as to whether the science was presented in an unbiased manner," said Democratic Rep. Rosa DeLauro, who has urged Avandia's withdrawal.
Panelists sat through nearly 20 presentations on Avandia that often drew opposite conclusions.
The panel's vote to keep Avandia on the market is a vote of confidence in FDA leaders, who have been criticised 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 emphasised 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 in risk," said John Jenkins.
Panelists appeared to heed the cautionary tone.
"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 FDA first approved Avandia in 1999 and it quickly became the top-selling diabetes pill in the world. U.S. sales have plummeted from $US2.2 billion ($A2.49 billion) in 2006 to $US520 million ($A587.97 million) last year as safety concerns swirled around the drug.
The drug works by increasing the body's sensitivity to insulin, a crucial protein needed for digestion that diabetics do not adequately produce.
While there are more than a dozen diabetes drugs on the market, only Actos from Japan-based Takeda Pharmaceuticals works the same way as Avandia. U.S sales of Actos have risen steadily, hitting $US3.4 billion ($A3.84 billion) last year, as Avandia's reputation has soured.
Critics of Avandia say there is no reason to leave the drug on the market when Actos provides the same benefits without the potential heart risks.
FDA is requiring GlaxoSmithKline to conduct a definitive study comparing the safety of the two drugs, but patient enrolment has slowed to a crawl due to Avandia's negative reputation.
The FDA panel said the study should go forward, though results will not be available for at least five years.
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 $US2.2 billion ($A2.49 billion) in 2006 to $US520 million ($A587.97 million) last year as safety concerns swirled around the drug.
Front page
RSS Feed