Incivek Gets Black Box Warning for Deadly Rash
Vertex Pharmaceuticals’ Hepatitis C medication Incivek received a black box warning last Wednesday (12/19/12) after two patients died from fatal skin rashes linked to the drug. According to reports, patients taking Incivek can develop a deadly rash that covers more than half the body.
FDA is adding a boxed warning to the Incivek drug label stating that Incivek combination treatment must be immediately stopped in patients experiencing a rash with systemic symptoms or a progressive severe rash (U.S. Food and Drug Administration).
At Least 2 Deaths Linked to Incivek
- The FDA is reporting that at least two patients (ages 47 and 69) died from severe skin reactions after taking Incivek in combination with peginterferon alfa and ribavirin (two other hepatitis C treatments.)
- The FDA also reported 112 nonfatal “adverse events” stemming from skin reactions to the Incivek combination treatment.
- DrugCite.com is reporting 2,397 adverse reports of epidermal and dermal conditions related to Incivek.
- DrugCite also reports 68 deaths linked to the drug, although it is not clear how many are from the fatal skin rashes.
FDA Black Box Warning for Incivek
The FDA says patients taking Incivek in combination with peginterferon alfa and ribavirin should stop immediately if they develop a rash that grows worse or comes with symptoms like a fever, diarrhea, or mouth sores.
The Black Box Warning reads:
FDA received reports of serious skin reactions, some fatal, in patients taking the hepatitis C drug Incivek (telaprevir) in combination with the drugs peginterferon alfa and ribavirin (Incivek combination treatment). Some patients died when they continued to receive Incivek combination treatment after developing a worsening, or progressive rash and systemic symptoms (symptoms affecting the entire body).
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.
What is Incivek?
- Incivek is a hepatic C virus NS3/4A protease inhibitor.
- Incivek is 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.
- Incivek is manufactured by Vertex Pharmaceuticals and was approved by the FDA in May 2011 to treat adults with chronic Hepatitis C infection who had not undergone standard interferon therapy or had not responded to it.
Contact An Experienced Incivek Attorney
Thomas J. Henry is currently accepting Incivek cases for evaluation. If you or someone you love has suffered as a result of Incivek, you may be entitled to financial compensation. Contact Thomas J. Henry today for a free case review.