The U.S. Food & Drug Administration announced that it has placed a black box warning on Incivek, a hepatitis-C drug generally used by liver disease patients. Manufactured by Vertex Pharmaceuticals, the drug has been linked to serious rash conditions including Toxic Epidermal Necrolysis (TEN), Stevens-Johnson Syndrome (SJS) and Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) – all of which can lead to serious injury or death.

Incivek Black Box Warning

The FDA issued an Incivek black box warning on December 19, 2012 after receiving reports of serious and fatal skin conditions in patients taking Incivek (telaprevir) in combination with other drugs such as peginterferon alfa and ribavirin (known as an Incivek combination treatment). According to the FDA, 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).

A black box warning, the strongest warning available to the FDA, signifies that medical studies indicate that the drug carries a significant risk of serious or even life-threatening adverse effects. The FDA is warning patients to stop using the drug except under very limited circumstances.

Reported Incivek Side Effects

Reported Incivek side effects / injuries include:

• Toxic Epidermal Necrolysis (TEN). TEN is a rare, but life-threatening skin condition in which the top layers of skin detach from the lower layers of skin all over the body.
• Stevens-Johnson Syndrome (SJS). SJS is also a rare, but potentially life-threatening skin condition which can result in the top layers of skin to die and shed.
• Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). DRESS is a term used to describe severe reactions to drugs which result in rash, affect internal organs, cause hematologic (blood) abnormalities and other systemic illnesses.

All of these side effects can lead to serious injury and possibly death. In addition to these, the FDA has reported that other, less serious side effects may include fever, nausea, diarrhea, mouth sores or ulcers, facial swelling (edema), red or inflamed eyes, or swelling or inflammation of the liver (hepatitis).

If you’ve suspect that you have an Incivek drug injury claim, please call The Driscoll Firm, LLC,  to discuss your situation. We are committed to helping patients harmed by dangerous drugs. We’re available to help you.