If you suffered a serious skin reaction after taking Incivek (generic: telaprevir) to treat Hepatitis C, contact a Texas Incivek layer immediately. The FDA has received reports of two deaths and more than 112 cases of serious skin reactions linked to Incivek. Unfortunately, many of these serious injuries occurred because patients and doctors were not aware of the importance of stopping Incivek if a skin reaction occurs.
What is Incivek?
Incivek (generic: telaprevir) is a drug that was invented by Vertex Pharmaceuticals, Inc. It was approved by the U.S. Food and Drug Administration (FDA) in 2011. Incivek is used to treat Hepatitis C in combination with peginterferon alfa and ribavirin (Incivek combination treatment). Hepatitis C is a viral disease that can cause chronic liver disease.
FDA Warning for Incivek
The FDA published a Safety Communication on December 19, 2012 to warn about reports of severe rashes and skin reactions linked to Incivek combination treatment. Unfortunately, “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).”
The FDA is aware of two deaths linked to Incivek skin reactions, including a 47-year-old woman and a 69-year-old man in Japan. Since the drug was approved, the FDA has received 112 reports of serious skin reactions. Incivek has been prescribed to about 50,000 patients.
The FDA will be adding a Boxed Warning to more prominently warn about the risk of deadly skin reactions. They also recommend:
“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.”
Incivek Skin Reactions and Rash
Skin reactions are a known side effect of Incivek, and the original label included this side effect information. The Boxed Warning will give more prominence to the importance of stopping Incivek if a skin reaction occurs.
Incivek has been associated with several life-threatening skin reaction diseases:
- Toxic Epidermal Necrolysis
- Stevens-Johnson Synrdrome
- Drug rash with eosinophilia (higher than normal level of white blood cells)
Symptoms of an Incivek Skin Reaction
Typical symptoms of serious skin reactions may include:
- Rash with or without itching, bumps, blisters, or ulcerations, that does not improve after 2-3 days or gets progressively worse
- Mouth sores or ulcers
- Facial swelling (edema)
- Red or inflamed eyes
- Ulcerations of the lips or eyes
- Swelling or inflammation of the liver
- And more