FDA Restricts Diabetes Drug Over Heart Risk

But regulators stop short of an outright ban on Avandia
By Kevin Spak,  Newser Staff
Posted Sep 23, 2010 12:34 PM CDT
A pharmacist displays three Avandia pills at Maximart Pharmacy in Palo Alto, Calif., Wednesday, June 30, 2010.   (AP Photo/Paul Sakuma)
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(Newser) – The FDA today put severe restrictions on Avandia, GlaxoSmithKline’s embattled diabetes drug, but stopped short of banning it outright. The once-popular drug will now only be available only as a last resort to type 2 diabetes patients who can’t control their glucose levels with any other medication, the AFP reports. Avandia has come under fire because data suggests it carries, in the FDA’s words, “an elevated risk of cardiovascular events” like heart attacks and strokes.

Regulators in Europe, meanwhile, pulled the drug off the market altogether, Bloomberg reports. "We struggled with it, and colleagues in other jurisdictions struggled as well," said the European Medicines Agency's top medical officer. "There’s no single perfect tool to study this risk." GlaxoSmithKline sent out an email saying it would stop promoting the drug. But it also issued a statement saying it "continues to believe that Avandia is an important treatment."

For more on the controversy over the drug, click here.

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