FDA overturns safety limits on diabetes drug

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Associated Press

Posted on November 25, 2013 at 6:02 PM

WASHINGTON (AP) — The Food and Drug Administration is lifting severe safety restrictions on the former blockbuster diabetes pill Avandia.

The FDA's repeal is based on recent data suggesting that the much-debated medication does not increase the risk of heart attack.

The reversal means patients will no longer have to enroll in a special registry to be eligible to receive the drug. Additionally, the drug will be available at most pharmacies. It was previously limited to certain registered pharmacies.

The safety restrictions and others were put in place in 2010, severely curbing U.S. prescriptions for the GlaxoSmithKline drug. The British drugmaker has spent more than a half-decade defending the safety of Avandia. It was once the best-selling diabetes drug in the world. Sales began plummeting in 2007 after researchers first raised questions about possible links to heart attacks.

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APPHOTO NYBZ110: 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) (30 Jun 2010)

<<APPHOTO NYBZ110 (06/30/10)££

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