Diabetes drug Avandia gets backing, with restrictions, of FDA advisers

WASHINGTON - 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 because of 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 medication.

Advisory recommendations are not binding, and the FDA is expected to take at least several weeks to consider its response, but the panel's expression of increased concern is likely to further reduce doctors' reliance on what was once the prescription of choice for treating Type 2 diabetes.

Steven Nissen, a Cleveland Clinic cardiologist whose 2007 analysis of multiple studies of Avandia touched off much of the controversy over the drug, said after the panel's vote, "They gave the leadership of FDA enough ammunition to withdraw the drug if they want to withdraw it."

Still, the vote was somewhat of a victory for British drug maker Glaxo, which is facing thousands of lawsuits from patients who say Avandia caused their heart attacks or strokes. Although the company may fare better in court because of the panel ruling, sales of Avandia are likely to shrink to minuscule levels.

The vote came despite an earlier ruling by the panel that Avandia appears to increase heart attack risk.

Panelists voted 21-4 that Avandia is more likely to cause heart attack than is its closest competitor, Actos. Eight panelists said there was not enough information to make a decision.

Ultimately, though, panelists said the risks were not severe enough 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 Lamont Weide, a physician and professor at the University of Missouri who voted to leave the drug on the market with new restrictions.

The agency convened the two-day panel meeting to help untangle more than 1,000 pages of conflicting evidence about Avandia's risks.

The drug has a long, knotty history at the FDA. Because diabetics are predisposed to heart risks it is extremely difficult to tell which heart attacks are drug-related and which are caused by the disease.

The task of evaluating Avandia's possible side effects across dozens of studies has dragged on for years without definitive answers.

Three years ago a similar FDA panel voted to keep Avandia on the market, and the FDA responded by adding warning labels for the drug in darker type.

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.

The drug works by increasing the body's sensitivity to insulin, a key protein needed for digestion that diabetics don't adequately produce.