December 19, 2012 – Vertex Pharmaceuticals’ popular oral hepatitis C drug Incivek (generic: telaprevir) will now carry a ‘black box’ warning – the strongest warning required by federal health authorities – about potentially fatal skin reactions, according to a press release issued today by the U.S. Food & Drug Administration (FDA). The action was taken after multiple deaths were reported in users of the drug, which emerged during postmarketing surveillance.
What’s the problem?
The new Incivek warning states that combination therapy should be discontinued immediately in individuals suffering from adverse skin reactions, such as rashes with systemic symptoms or progressive severe rashes. Use of other medications that have the potential to cause skin reactions should also be avoided, according to the FDA.
According to a statement released by Vertex, “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.”
Skin reactions were noted during pre-approval clinical trials conducted on Incivek, including several events which were considered life-threatening and required emergency hospitalization. This risk was noted on the drug’s original label, but such events were considered rare, affecting less than 1% of patients (all of whom fully recovered).
The deaths associated with Incivek were reported during postmarketing surveillance, and it is still unclear exactly how many fatalities have been linked to the drug.