The FDA warned that AbbVie’s new hepatitis C treatments -- Viekira Pak and Technivie -- may cause serious liver harm in patients with underlying liver disease.
The FDA isssued a safety alert stating it has received reports of liver failure and complications in patients with cirrhosis who were taking the AbbVie meds.
AbbVie is updating the drug labels to warn against their use in a subset of hepatitis C patients with more advanced cirrhosis, and to advise doctors to assess whether patients have liver dysfunction before suggesting treatment.
The FDA approved Viekira Pak in December 2014 and Technivie in July 2015. Abbvie announced results from a late stage clinical trial iin June that found that Viekira Pak, which combines Viekirax and Exviera, proved to have 100% cure rates in patients.
Read the WSJ release