FDA overturns safety restrictions on diabetes pill Avandia based on new safety data

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FILE - In this file photo made June 30, 2010 three Avandia pills are displayed near the bottle in Palo Alto, Calif. The Food and Drug Administration said Monday, Nov. 25, 2013, it is lifting severe safety restrictions on the former blockbuster diabetes pill Avandia, citing recent data suggesting that the much-debated medication does not increase the risk of heart attack. (AP Photo/Paul Sakuma, File)

WASHINGTON – The Food and Drug Administration is lifting severe safety restrictions on the former blockbuster diabetes pill Avandia, citing recent data suggesting that the much-debated medication does not increase the risk of heart attack.

The repeal means patients will no longer have to enrol in a special registry to be eligible to receive the drug. That safety requirement, put in place in 2010, sharply reduced Avandia prescriptions in the U.S.

The ruling is a belated victory for British drugmaker GlaxoSmithKline after more than a half-decade defending the safety of Avandia, which was once the bestselling diabetes drug in the world.

Sales began plummeting in 2007 after researchers first raised questions about possible links to heart attacks. After three years of debate, the FDA limited access to the drug in 2010.

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