December 20, 2012
The Food and Drug Administration (FDA) is requiring a black box warning on the Vertex Pharmaceuticals hepatitis C medication Incivek due to a potentially fatal skin rash. The FDA says that patients taking Incivek in combination with the medications ribavirin and interferon, which is taken by injection, should stop taking it immediately if they develop a rash that becomes worse or develops in tandem with other symptoms, such as fever, diarrhea, or mouth sores. The black box warning is the most serious form of safety warning available for medications.