FDA Demands Stronger Warnings For TNF-Blockers

Law360, New York (September 4, 2008, 12:00 AM EDT) -- The U.S. Food and Drug Administration said Thursday that the manufacturers of four drugs known as tumor necrosis factor alpha blockers must strengthen existing safety warnings for the medications in the wake of reports of invasive fungal infections and several deaths.

In calling for the move, the agency exercised its new authority under the Food and Drug Administration Amendments Act of 2007 to require manufacturers of TNF inhibitors to make safety-related changes to prescribing information for Centocor Pharmaceuticals' Remicade, Amgen Inc.'s Enbrel, Abbott Laboratories' Humira and...
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