The US Food and Drug Administration has issued a warning stating that Vertex Pharmaceuticals' hepatitis C drug, known as Incivek, could lead to formation of a deadly skin rash.
FDA also warned that people who were taking Incivek, which is a brand name for telaprevir, in combination with two other drugs should stop if they develop a rash or suffer from symptoms including diarrhea, fever or mouth sores. There were also cases of fatalities among some of the patients. Vertex confirmed that Incivek could increase the risk of such skin rashes and added that the drug's packaging with come with a black box label warning.
Advertisement"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. Given the severity of the events reported in the postmarketing setting, and the importance of discontinuing Incivek combination treatment in the event of one of these reactions, the information has been given greater prominence through a boxed warning", Vertex said in a statement.