Monday, February 07, 2011

GlaxoSmithKline updates diabetes pill labeling to include FDA-ordered safety restrictions | StarTribune.com

WASHINGTON - GlaxoSmithKline said Monday it has updated the labeling of its diabetes pill Avandia to include safety restrictions ordered by federal health authorities because of the drug's links to heart attack.

The Food and Drug Administration announced the changes in September as the last in a series of safety actions against the former blockbuster drug, which has triggered thousands of lawsuits and a Department of Justice investigation. The European Union has banned the drug.

The new U.S. label indicates the drug is only intended for patients who cannot control their blood sugar with any of the other diabetes medications on the market. Patients who are currently on the drug can continue taking it after consulting with their doctor.

Posted via email from Jack's posterous

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