The U.S. Food and Drug Administration (FDA) issued a safety communication after receiving reports that the combination treatment Hepatitis C drugs Incivek (telaprevir), peginterferon alfa and ribavirin has been causing severe skin reactions in some patients.
The symptoms of the rash are so severe that they affect the entire body, according to the FDA. The agency is adding a black box warning to Incivek’s drug label, stating that the drug must be stopped immediately if the patient experiences any symptoms of severe rash. Symptoms include a rash that doesn’t itch, a progressive rash that only gets worse, fever, nausea, diarrhea, sores or ulcers in the mouth, red or inflamed eyes, swelling of the face or swelling of the liver.
The FDA said it received two reports of severe skin reactions from Japan. In one of the cases, the patient died after he continued to use the combination treatment even after he saw signs of rash.
Serious skin reactions associated with the treatment include Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), a drug rash with eosinophilia (a higher than normal level of white blood cells called eosinophils) and systemic symptoms (or DRESS).
These skin reactions are severe and can be deadly. All patients with these conditions require hospitalization. It is important that all patients taking Incivek combination treatment understand the risk of these skin conditions and seek medical attention immediately should they experience any signs or symptoms.
Incivek is always used in combination with peginterferon alfa and ribavirin. It is a hepatitis C virus NS3/4A inhibitor used to treat genotype 1 chronic hepatitis C in some adult patient.
For more information, view the complete FDA communication here.
If you or someone you love has developed one of these severe and painful conditions, you may be entitled to financial compensation. To learn more, contact the drug injury lawyers of Flood Law Group today. We represent individuals and families that are affected by severe drug reactions and can help you collect compensation for your suffering.