FDAnews Drug Daily Bulletin

FDA Requiring AbbVie to Include Warning on Hep C Treatments

Oct. 29, 2015

The FDA is requiring AbbVie to update its labeling for hepatitis C treatments Viekira Pak and Technivie to include a warning about the chance of serious liver injury in patients with underlying advanced liver disease.

According to a safety alert issued last week, at least 26 cases have been reported worldwide of hepatic decomposition and liver failure, including cases resulting in liver transplantation and death, usually occurring within one to four weeks of starting treatment.

Viekira Pak and Technivie — both ombitasvir/paritaprevir/ritonavir — were approved by the FDA in 2014 and 2015, respectively.