Illnesses, Deaths Spur FDA Warning on Hep C Drugs
By Robert Preidt
FRIDAY, Oct. 23, 2015 (HealthDay News) — Reports of deaths and illnesses occurring soon after use are prompting the U.S. Food and Drug Administration to issue warnings on two drugs used to fight the hepatitis C virus.
The drugs, called Viekira Pak and Technivie, appeared linked to serious liver damage in patients with advanced liver disease, the agency warned in a statement issued Thursday.
Of 26 cases reported worldwide where use of the medications has been the possible or probable cause of illness, 10 patients either died or required organ transplant after liver failure, and 16 patients had some form of liver dysfunction. In most cases, liver damage occurred within one to four weeks of patients starting treatment, the FDA said.
The cases occurred after the two drugs were approved by the FDA — Viekira Pak in December of 2014 and Technivie in July of 2015, the statement said. The agency believes that there may be other cases that have gone unreported.
Based on the reports, the FDA is now warning that “Viekira Pak and Technivie may cause serious liver injury, including life-threatening liver failure, mainly in patients with underlying advanced liver disease.”
And, “as a result,” the agency added, “we are requiring the manufacturer [AbbVie] to add new information about this safety risk to the drug labels.”
The FDA says that anyone taking Viekira Pak or Technivie who begins experiencing “fatigue, weakness, loss of appetite, nausea and vomiting, yellow eyes or skin, or light-colored stools” should contact their doctor immediately, as these symptoms might indicate liver injury.
“Patients should not stop taking these medicines without first talking to their health care professionals,” the FDA added, because “stopping treatment early could result in drug resistance to other hepatitis C medicines.”
Viekira Pak and Technivie are used to treat patients with chronic hepatitis C, an infection that can last a lifetime and lead to serious liver and other health problems, including cirrhosis, liver cancer and death. These drugs lower the amount of hepatitis C virus in the body by preventing it from multiplying and may slow down the disease, the FDA statement explained.