Drug Information Update- New FDA Drug Safety Communication on Viekira Pak (ombitasvir, paritaprevir and ritonavir; dasabuvir) and Technivie (ombitasvir, paritaprevir and ritonavir)

The Division of Drug Information (DDI) is CDER's focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA

The U.S. Food and Drug Administration (FDA) is warning that hepatitis C treatments Viekira Pak and Technivie can cause serious liver injury mostly in patients with underlying advanced liver disease. As a result, we are requiring the manufacturer to add new information about this safety risk to the drug labels.

Patients taking these medicines should contact their health care professional immediately if they develop fatigue, weakness, loss of appetite, nausea and vomiting, yellow eyes or skin, or light-colored stools, as these may be signs of liver injury. Patients should not stop taking these medicines without first talking to their health care professionals. Stopping treatment early could result in drug resistance to other hepatitis C medicines. Health care professionals should closely monitor for signs and symptoms of worsening liver disease, such as ascites, hepatic encephalopathy, variceal hemorrhage, and/or increases in direct bilirubin in the blood.

Viekira Pak and Technivie are used to treat chronic hepatitis C, a viral infection that can last a lifetime and lead to serious liver and other health problems, including cirrhosis, liver cancer, and death. These medicines reduce the amount of hepatitis C virus in the body by preventing it from multiplying and may slow down the disease.

For more information, please visit: Viekira Pak and Technivie.