Black-Box Warning Added to Hepatitis C Medication

Black-Box Warning Added to Hepatitis C Medication | Pintas & Mullins Law Firm

Hepatitis C (HCV) is a slow-progressing liver infection that can develop through exposure to the blood of an infected person. 150 million people around the world live with chronic HCV. 3.2 million of them live in the U.S. There is currently no vaccine for HCV.HCV Drug Gets Black-Box Warning

Harvoni is an antiviral drug that prevents HCV from growing and spreading throughout the body. Unlike traditional forms of HCV medication, Harvoni doesn’t use Interferon or Ribavirin, two drugs that have caused severe side effects in HCV patients.

Harvoni was issued a black-box warning by the FDA in February 2017—three years after being approved for market.


Harvoni patients take the “miracle” pill once every day, and many enjoy results in as little as eight weeks. Traditional HCV medications take longer to work, so it’s no wonder that many people have chosen to use Harvoni. Since its inception, the drug has cured 90% of patients with Type 1 HCV.

Recent FDA findings have shown that many Harvoni users, although cured of HCV, have experienced either a new case or a recurrence of Hepatitis B (HBV). The drug has even led to liver failure, and death, for some.

The FDA continues to study why such a flare-up of HBV occurs.


Acute (short-term) HCV often clears up on its own, while chronic (long-term) HCV may damage the liver over time. Consult with your doctor about your HCV treatment options. Tell your doctor if you’ve had a history of HBV, liver problems other than hepatitis, kidney disease, or have had a liver transplant, as those factors could help your doctor decide if Harvoni is right for you.


If you or a loved one has suffered from Hepatitis B after using Harvoni, contact our firm today. Our team of dangerous drug lawyers provide free case reviews to anyone with questions or concerns about Harvoni. Our consultations are completely free and available to concerned patients nationwide.