GSK Tightens Avandia Restrictions

Law360, New York (February 7, 2011, 4:39 PM EST) -- Under orders from health regulators, GlaxoSmithKline PLC said Monday it had revised safety restrictions on the diabetes drug Avandia because of its links to heart attacks, in a move closely following a key settlement in multidistrict litigation over the drug.

GSK said its Avandia labels would include new language restricting Avandia to patients with Type 2 diabetes who were already taking a rosiglitazone-containing medicine or unable to control the disease with other drugs.

The labels also limit use of Avandia to patients who have decided not...
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