Vertex Updates Incivek Label to Note Fatal Skin Reactions
Dec 20th 2012 1:39PM
Updated Dec 20th 2012 1:46PM
Vertex Pharmaceuticals updated the label on its hepatitis C drug Incivek to include a boxed warning stating that fatal and non-fatal serious skin reactions have been reported in patients taking Incivek combined with peginterferon alfa and ribavirin.
The label previously mentioned reports of serious skin reactions in the warnings and precautions section, and that the drug combination should be discontinued immediately when serious skin reactions occur, but didn't mention that it could be fatal. Less than 1% of patients in the phase 3 clinical trials were diagnosed with a serious skin reaction, and all recovered after discontinuing the drug regimen.
After deaths occurred from patients continuing to take the medication after a serious skin reaction was identified, Vertex, in combination with the Food and Drug Administration, decided to highlight the potential side effects in a boxed warning on the label.
The label was also updated to include additional information on the time to onset and management of anemia in patients taking Incivek combination.
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