In the wake of multiple reported deaths associated with the hepatitis C drug telaprevir (brand-name Incivek), the medication will now carry a black box label warning about potentially fatal skin reactions.
The drug is taken in conjunction with two other drugs, and the new warning stresses that the treatment should be stopped immediately if a patient exhibits serious skin reactions, such as a progressive severe rash.
A new statement issued by the manufacturer, Vertex Pharmaceuticals, said, “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.”
There had been reports of skin reactions during the drug’s clinical trials. Some of the reactions had been severe enough to require hospitalization, but there were no fatalities noted. The reaction was fairly rare, affecting less than one percent of patients.
The company declined to identify how many reports it has received of fatal reactions, but said, “given the severity of the events reported in the postmarket setting … the information has been given greater prominence through a boxed warning.”
The U.S. Food and Drug Administration (FDA) approved Incivek in 2011. The new black box warning for Incivek indicates that it may pose a significant risk of serious or even life-threatening adverse events. It is the most serious warning the FDA can require for a prescription drug.
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