The Food and Drug Administration posted an exhaustive 700-page review of the GlaxoSmithKline drug online Friday ahead of a meeting next week to review the safety of Avandia, which is used by hundreds of thousands of diabetics in the U.S.
The FDA holds a special two-day meeting starting Tuesday to help decide what course of action to take. A panel of outside expert physicians will vote on recommendations for Avandia including:
- adding more warning labels
- limiting which doctors can prescribe the drug
- pulling the drug from the market
The agency is seeking outside advice in part because of disagreements among its own scientists.
"There's not complete unanimity within the FDA about the interpretation of these data, and that's one of the reasons we're going to the advisory committee," said Dr. Janet Woodcock, head of the FDA's drug center.
The European agency that evaluates medicine said Friday that it would review Avandia one week after the FDA's panel meets.
Avandia was Glaxo's third-bestselling drug in 2006, with U.S. revenue of $2.2 billion, according to healthcare statistics firm IMS Health. But safety concerns swirling around the drug have pummeled sales since 2007, with sales falling 75% to $520 million last year.
In 2007 an analysis of dozens of studies first linked the drug to heart attacks. The FDA responded by adding a warning label to the drug that year.
But new data on Avandia's risks and pressure from Capitol Hill have prompted the agency to reexamine the drug's safety.
Avandia is still used by hundreds of thousands of Americans with type 2 diabetes to control blood sugar levels. The drug works by increasing the body's sensitivity to insulin, a key protein needed for digestion.