Telaprevir (Incivek) is an oral medication approved for hepatitis C. Clinical trials demonstrated that less than 1% of patients receiving the drug experienced serious skin reactions, although skin reactions were listed in the medication’s warnings and precautions section of the label. Now, the labeling for telaprevir has been updated to include a Boxed Warning that states that fatal and non-fatal serious skin reactions have been reported in patients receiving telaprevir combination treatment.
According to news reports, the Boxed Warning is intended to convey the nature of these events, given the severity of reactions in the post-marketing setting. The Boxed Warning is also meant to demonstrate the importance of discontinuing telaprevir combination treatment in the event that these serious skin reactions occur.
In Phase III clinical trials, the less than 1% of people who experienced a serious skin reaction required hospitalization, although all patients recovered. The updated Boxed Warning also includes additional information about the time to onset of symptoms and management of anemia.
