The U.S. Food and Drug Administration (FDA) believes the Hepatitis C drug telapriver—sold under the brand name Incivek—might cause severe skin reactions when taken in combination with peginterferon alfa and ribavirin.
What Is Incivek and What Is It Prescribed For?
The Massachusetts-based company Vertex Pharmaceuticals, Inc. designed and manufactures Incivek, which the FDA approved in tablet form in May 2011. The drug treats Hepatitis C by inhibiting replication of the virus. Incivek is always prescribed with two other Hepatitis C drugs, peginterferon alfa and ribavirin.
Incivek Might Cause Life-Threatening Skin Reaction Side Effects
On December 10, 2012, the FDA issued a drug safety communication warning the public that, when used with peginterferon alfa and ribavirin, Incivek can cause severe, progressive skin reactions. As a result, the FDA ordered Vertex Pharmaceuticals to include a “black box” warning on Incivek’s label. Such warnings are the FDA’s most serious kind of alert.
The agency ordered the label change because of two reports from Japan of patients taking the Incivek combination treatment and developing toxic epidermal necrolysis (TEN). TEN is a frequently fatal condition that occurs when the top layer of the skin (the epidermis) separates from the next layer (the dermis) and then dies. It is a more severe version of Stevens-Johnson Syndrome (SJS). According to the FDA, one patient, a 50-year-old woman, survived TEN after treatment was discontinued, but the other, a 69-year-old man, died after the epidermal necrolysis spread across his body and his organs ceased functioning.
The FDA also believes that the Incivek combination treatment is linked with drug rash with eosinophilia and systemic symptoms (DRESS). Eosinophilia is a condition characterized by an above-normal level of white blood cells. Between May 23, 2011, and June 19, 2012, the FDA identified 92 adverse event reports linking Incivek combination treatment with DRESS, as well as 20 similar cases of SJS. One 47-year-old woman died of DRESS.
Symptoms of SJS, TEN, and DRESS include:
- Rash with or without itching
- Severe rash with raised bumps, blisters, or ulcerations
- Rash that does not improve after 2-3 days
- Rash that gets progressively worse
- Mouth sores or ulcers
- Swelling of the face
- Red or inflamed eyes (like “pink eye”)
Anyone taking Incivek combination treatment should consult with a health care professional immediately.
RLG’s Incivek Lawyers Will Make Things Easier
The process of demanding compensation for the harm you’ve suffered can be complicated, even if it doesn’t seem fair that you should have to go through even more trouble to be made whole again. The Incivek lawyers at the Rottenstein Law Group believe that obtaining legal satisfaction from those who harmed you shouldn’t require more hardship. That’s why we do everything we can to streamline the process, and we will file an Incivek lawsuit on your behalf if necessary. RLG will also keep you up to date on any Incivek class action lawsuits, additional FDA Incivek warnings, and Incivek FDA recall announcements. If you or a loved one has taken Incivek combination treatment and believe it caused a severe skin reaction, contact RLG today.