GlaxoSmithKline's diabetes drug Avandia should remain on the market but with new restrictions due to possible heart risks, says a federal panel of health experts.
The U.S. Food and Drug Administration advisers voted 20-12 to keep the medicine available -- 10 panelists also recommended limiting who can get and prescribe the drug. The FDA isn't required to follow the advice of its panels, but it often does. Once a drug that brought in billions in sales annually, Avandia's market share has plummeted in recent years after data showed a possible increase risk of heart attacks.
For two days the panel sifted through data -- both supporting and against Avandia -- before taking its vote Wednesday. In a statement released after the vote, GlaxoSmithKline's chief medical officer Dr. Ellen Strahlman vowed to continue working with the FDA "in the best interest of diabetes patients who face this chronic and serious disease."
The FDA plans to take the recommendations under advisement as it "evaluates the regulatory options available to us," Janet Woodcock, the agency's drug division head, told Dow Jones Newswires.
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