FDA Warns Hepatitis C Drugs Could Cause Severe Liver Damage To Patients With Underlying Liver Disease.

The Wall Street Journal (10/23, Loftus, Subscription Publication) reports that the Food and Drug Administration issued a warning on Thursday that AbbVie Inc.’s Viekira Pak (ombitasvir/paritaprevir/ritonavir with dasabuvir) and Technivie (ombitasvir/paritaprevir/ritonavir) may cause severe liver damage to patients who have an underlying liver disease.

The Washington Post (10/23, Dennis) reports that the FDA said it had received reports of at least 26 cases since late 2014 of patients “who either died or had to undergo liver transplantation” after taking the hepatitis C drugs, with the liver damage occurring in the first month of treatment. According to the Post, the agency “will require AbbVie to add new warnings to the safety labels of the drugs for patients who already have advanced liver disease linked to hepatitis C” and “urged doctors to closely monitor patients taking the drugs for symptoms of worsening liver disease.” Bloomberg News (10/23, Bloomfield) and the AP (10/23, Perrone) also cover the story.