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Dec. 19, 2012: Vertex Pharmaceutical announced that because of some recent fatalities among hepatitis C patients being treated with Vertex’s telaprevir (Incivik®), new warnings have been placed on packaging about a potentially fatal skin reaction. The current Standard of Care for hepatitis C patients with Genotype 1 is ‘triple therapy’: interferon plus ribavirin plus a protease inhibitor – either telaprevir or boceprevir (Merck’s Victrelis®). Note that the danger is not sudden, but progressive, and ends once treatment is discontinued. Though severe rash was a side-effect in telaprevir clinical trials, there were no fatalities until after its approval and release.
Vertex’s press release says: “Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the INCIVEK® (telaprevir) label in the United States has been updated to include a Boxed Warning stating that fatal and non-fatal serious skin reactions have been reported in patients taking INCIVEK combination treatment. Fatal cases of serious skin reactions have been reported in patients with progressive rash and systemic symptoms who continued to receive INCIVEK combination treatment after a serious skin reaction was identified. “
More info here from Vertex Press Release and related Med Page press release