WASHINGTON — Federal health officials are warning doctors and patients that two hepatitis C drugs from AbbVie can cause life-threatening liver injury in patients with advanced forms of the disease.
The Food and Drug Administration says it will require AbbVie to add new warnings to Viekira Pak and Technivie about their risks for patients who already have advanced liver damage caused by hepatitis C.
The warning could reshape the growing field of high-priced drugs to treat the virus, which also includes Gilead Science's Sovaldi and Harvoni.
Roughly 2.7 million Americans have the virus, which if left untreated, can cause liver failure and liver cancer.
AbbVie's drugs are part of a new wave of pill-only combinations that cure more patients and cause fewer side effects than older treatments, which combined pills and injections.
The Associated Press