WASHINGTON – Independent experts urged U.S. federal regulators Thursday to reduce restrictions on Glaxo- SmithKline’s controversial diabetes drug Avandia, which has been banned in Europe over concerns of increased risk of heart attacks.
Thirteen members of the 26-member independent advisory panel convened by the Food and Drug Administration said strict U.S. restrictions imposed in 2010 should be eased.
Seven experts voted to lift them entirely, and five to keep them.
Only one said Avandia should be taken off the market.
The panel voted at the end of two days of meetings on a new review of the GSK trial called RECORD, which confirmed the company’s initial finding that Avandia does not raise cardiac risk more than other diabetes drugs.
The British pharmaceutical giant GSK recently paid researchers at Duke University in North Carolina to carry out the new analysis of the data.
The FDA is under no obligation to follow the recommendations of expert panels, though it usually does.
Once a blockbuster drug for patients with type 2 diabetes, Avandia was approved in 1999 and soared to sales of $3 billion per year, but its use has declined dramatically in recent years.
Other research has pointed to a rise in heart attacks and strokes among patients using Avandia to control their blood sugar, and critics have alleged flaws in the RECORD trial, which showed it was relatively safe.
The Avandia controversy erupted after a 2007 study in the New England Journal of Medicine found that it raised the risk of heart attack by 43 percent.
The lead author of that study, Steven Nissen of the Cleveland Clinic, has been outspoken against Avandia and told The Wall Street Journal this week that RECORD was “not conducted in a scientifically acceptable manner.”
He also said that the FDA denied his request to be part of the committee of experts reviewing the data.