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What actions were taken by the FDA after Ketek was linked to severe liver complications?

April 26, 2017Actions complications fda ketek linked liver severe

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What actions were taken by the FDA after Ketek was linked to severe liver complications?

1 Answer

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The FDA approved a labeling supplement submitted by Aventis Pharmaceuticals as a “Changes Being Effected” (CBE) supplement, which highlights the ‘Warnings’ section of the labeling to raise attention to the risk of liver toxicity associated with Ketek.