Hepatitis C is a viral disease that affects the liver. Over time, the scarring from the disease can cause cirrhosis, liver failure, and liver cancer. Patients who have hepatitis C often have compensated liver disease. This means only part of the liver still works. Because the liver is directly involved in how drugs react in the body, doctors must use caution when prescribing drugs to patients with liver disease. Patients who have hepatitis C with compensated liver disease are given the drug Incivek in combination with two other treatments to treat hepatitis C.
Incivek was approved for the treatment of hepatitis C in May 2011. Only 18 months later, the Food and Drug Administration (FDA) placed a black box warning on the drug. Patients undergoing combination treatment with Incivek are at risk of a deadly skin rash known as Stevens-Johnson syndrome. The FDA has received at least two reports of deaths associated with the disease. The FDA has also received at least 112 reports of nonfatal adverse reactions to the drug.
Early symptoms of Stevens-Johnson syndrome include a skin rash that gets worse, fever, diarrhea, and mouth sores. The rash may blister and spread to cover more than half the body. Complications include infection, skin damage, eye problems, organ damage, and sepsis.
Vertex Pharmaceuticals, the maker of Incivek, says the label had already warned consumers about the possibility of a serious skin reaction. The black box label advises doctors and consumers of the risk of Stevens-Johnson syndrome and advises anyone who has symptoms of the disease to stop treatment immediately and seek emergency medical treatment.
Patients who have suffered adverse reactions to Incivek may be eligible for compensation through an Iowa class action pharmaceutical injury lawsuit. To learn more about Iowa Incivek claims, please contact the Cedar Rapids drug injury attorneys at Hupy and Abraham at 800-800-5678.