Product News and Recalls

FDA Warns Hepatitis C Drugs Can Cause Serious Liver Injury

hepatitis c drugs may cause liver damageThe U.S. Food and Drug Administration (FDA) recently issued a safety communication warning that the hepatitis C treatments Viekira Pak and Technivie may cause serious liver injury, especially in patients with advanced liver disease. Accordingly, the agency has requested that the drugs’ manufacturers add information about this risk to their products’ safety labels.

Viekira Pak and Technivie, both produced by pharmaceutical giant AbbVie, are used to treat chronic hepatitis C, an infectious disease that can lead to severe liver damage, cirrhosis, or death. The drugs work by slowing the spread of hepatitis C virus in the body.

A review of the FDA Adverse Event Reporting System database turned up 26 patients in whom liver injury was determined to be possibly or probably caused by Viekira Pak or Technivie components. Of these, “10 patients experienced hepatic failure resulting in transplantation or death, and 16 patients experienced various degrees of liver dysfunction.” The agency states that most of these 26 patients exhibited signs of advanced cirrhosis before treatment.

The FDA is now requiring AbbVie to include information about serious adverse liver effects Viekira Pak or Technivie may cause to the Contraindications, Warnings and Precautions, Postmarketing Experience, and Hepatic Impairment sections of the drugs’ labels. The agency is urging patients and practitioners to report any liver injury–related side effects they may observe to the FDA MedWatch program.

If you or a loved one suffered liver damage or cirrhosis after using Viekira Pak or Technivie, you should contact the attorneys at Lopez McHugh today for a free legal consultation.