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FDA adds boxed warning to hepatitis C drugs



October 12, 2016
Area(s) of Interest: Drug Prescribing/Dispensing Infectious Diseases Patient Care 

The U.S. Food and Drug Administration (FDA) is warning of serious, potentially life-threatening risks for patients infected with hepatitis B virus who are being treated with certain direct-acting antiviral medicines for hepatitis C virus (HCV). According to the FDA, direct-acting antiviral medicines for hepatitis C virus can reactivate hepatitis B virus. In a few cases, hepatitis B reactivation in patients treated with direct-acting antivirals resulted in serious liver problems or death. As a result, FDA is requiring a boxed warning about the risk of hepatitis B reactivation to be added to the drug label, directing health care professionals to screen and monitor for hepatitis B reactivation in all patients being treated with direct-acting antivirals.


Direct-acting antiviral medicines are used to treat chronic hepatitis C infection, an infection that can last a lifetime. These medicines reduce the amount of the virus in the body by preventing it from multiplying, and in most cases, they cure hepatitis C. Without treatment, HCV can lead to serious liver problems including cirrhosis, liver cancer, and death. More than 3 million people in the U.S. have hepatitis C, which is spread through blood and can necessitate a liver transplant.


For more information, see the FDA's Drug Safety Communication.

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