WASHINGTON (AP) — Federal health experts recommend modifying safety restrictions on former blockbuster diabetes pill Avandia, in light of a new analysis suggesting that the drug may not increase the risk of heart attack as previously believed.
A majority of Food and Drug Administration advisers voted to change measures that currently limit patient access to GlaxoSmithKline’s Avandia. Under current rules, patients must sign a waiver that they understand the drug’s risks before getting a prescription. The panel’s vote is a recommendation to the FDA and is not binding. Advisers will now discuss specific changes to the restrictions.
Avandia was once the best-selling diabetes drug in the world, but sales plummeted after heart attack concerns emerged in 2007. In 2010 the FDA limited access to the drug and European regulators banned the pill.