FDA Orders Stronger Avandia Warning
Posted By dhodges@kennedyhodges.com on Nov 15, 2007 11:32am PST
The Food and Drug Administration has ordered GlaxoSmithKline to include a "black box warning" for prescriptions of its best-selling diabetes drug Avandia. The warning will include information that use of Avandia is associated with greater risk of heart attack. The FDA warning falls short of measures taken by health agencies in Canada and Europe where officials either withdrew approval for the drug as a stand alone treatment or highly restricted use to select groups. Andrea Gerlin and Michelle Fay Cortez, Bloomberg 11/15/2007
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