Contact us 24/7

Incivek

Incivek and Deadly Skin Rashes

Vertex Pharmaceuticals’ hepatitis C medication Incivek has been blamed for serious skin reactions and deaths. The medication carries a black box warning, notifying users about the possibility of developing a fatal rash which may cover up to half the body.

INCIVEK- TREATMENT FOR HEPATITIS C

  • Incivek is a hepatitis C virus NS3/4A protease inhibitor manufactured by Vertex Pharmaceuticals.
  • Incivek was approved by the FDA in May 2011 to treat certain adults with chronic hepatitis C.
  • 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.

5,752 INCIVEK ADVERSE EVENTS REPORTED TO FDA

  • According to DrugCite.com, 5,752 adverse events have been reported to the FDA.
  • DrugCite.com is reporting 2,630 adverse reports of epidermal and dermal conditions related to Incivek.
  • DrugCite.com also reports 72 deaths linked to the drug.
INCIVEK LINKED TO STEVENS-JOHNSON SYNDROME AND TOXIC EPIDERMAL NECROLYSIS
  • Between May 2011 and June 2012, there were 92 documented cases of drug-related skin reactions and 20 documented cases of Stevens-Johnson Syndrome (SJS).
    • SJS is a severe skin reaction in which the top layer of skin blisters, separates, and sheds from the body.
  • There were also two cases of Toxic Epidermal Necrolysis (TEN) reported.
    • TEN is another severe skin condition in which the top layer of skin detaches from the layers below.
    • Of the two TEN cases linked to Incivek- one patient recovered after ending Incivek treatment, the other died of multi-organ failure.
FDA BLACK BOX WARNING FOR INCIVEK

Incivek received a black box warning in December 2012 after two patients reportedly died from fatal skin rashes linked to the drug. According to FDA reports, the two individuals, age 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 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.

HAVE YOU BEEN INJURED?

If you’ve been injured, we can help. Contact us