Reuters Health Information (2012-12-19): Vertex strengthens warning on telaprevir for hep C
Vertex strengthens warning on telaprevir for hep C
Last Updated: 2012-12-19 13:00:20 -0400 (Reuters Health)
(Reuters) - Vertex Pharmaceuticals Inc warned on Wednesday its hepatitis C drug telaprevir (Incivek), which is used in conjunction with two other drugs, can cause serious, potentially fatal skin reactions.
Skin rashes were already a known side effect of Incivek, but an analysis of data since the drug was approved in the United States in 2011 has revealed a number of cases in which the reaction was more severe than those seen in clinical trials of the drug. Some were fatal.
The findings have led Cambridge, Massachusetts-based Vertex to place an enhanced warning, surrounded by a black box, on the drug's prescribing label.
Incivek, Vertex's flagship product, is approved to treat hepatitis C in combination with interferon and ribavirin.
The company said the fatal cases of skin reactions occurred in patients who continued to receive Incivek combination treatment after a serious skin reaction was identified.