The FDA has received reports of two cases of a serious skin reaction called toxic epidermal necrolysis, one fatal, in patients taking the hepatitis C drug Incivek (telaprevir) in combination with the drugs peginterferon alfa and ribavirin (Incivek combination treatment). In the fatal case, the patient continued the Incivek combination regimen for a period of time after symptoms developed.
The Incivek drug label already contains information on the risk of serious skin reactions. Serious skin reactions, including drug rash with eosinophilia (a higher than normal level of white blood cells called eosinophils) and systemic symptoms (or DRESS) and Stevens-Johnson Syndrome (SJS) have been previously reported in patients taking Incivek combination treatment. These serious skin reactions required hospitalization, and in some cases, death was reported. The signs and symptoms of DRESS may include rash, fever, facial swelling, and evidence of internal organ involvement (e.g., hepatitis). Patients may or may not have eosinophilia. The signs and symptoms of SJS may include fever, lesions, and ulcerations on the eyes or lips.
Attorney Fred Pritzker is providing free consultations to patients and their families regarding a lawsuit against the manufacturer of the drug, Vertex Pharmaceuticals, Inc. (Vertex Pharma). You can contact Fred for a free consultation here.
FACTS ON INCIVEK (telaprevir)
Incivek must always be used in combination with peginterferon alfa and ribavirin.
Incivek is a hepatic C virus NS3/4A protease inhibitor indicated in combination with peginterferon alfa and ribavirin for the treatment of genotype 1 chronic hepatitis C in adult patients with compensated liver disease, including patients who have cirrhosis, are treatment-naïve, or who have been previously received interferon-based treatment.
If serious skin reactions occur, all three components of Incivek combination treatment, including peginterferon alfa and ribavirin, must be immediately discontinued, and the patient should receive urgent medical care. Consideration should also be given to stopping any other medications that may be associated with serious skin reactions.
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