FDA Slaps New Warning On Vertex's Hep C Drug After Deaths

Law360, Chicago (December 20, 2012, 2:19 PM EST) -- The U.S. Food and Drug Administration said Wednesday that it is adding a boxed warning to Vertex Pharmaceuticals Inc.'s Incivek hepatitis C drug after receiving reports of patients dying from serious skin reactions they developed while taking the medication.

The warning will state that use of Incivek combination treatment — it must always be used in combination with the drugs peginterferon alfa and ribavirin, according to the agency — must be immediately stopped in patients experiencing a rash with symptoms affecting the whole body or rash...
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