FDA Warns of Liver Problems for Some Taking Hep C Drugs
THURSDAY, Aug. 29, 2019 -- Taking the hepatitis C drugs Mavyret, Zepatier or Vosevi can trigger rare cases of severe liver problems or liver failure in patients who already have moderate-to-severe liver impairment, the U.S. Food and Drug Administration warned Wednesday.
The agency has identified 63 cases of worsening liver function, some resulting in liver failure or death, among patients taking the drugs.
While the medicines are safe and effective in patients with no or mild liver impairment, the same cannot be said for those with moderate-to-severe liver impairment, the FDA said.
"Hepatitis C virus remains a significant public health issue, but effective therapeutic options have helped patients to receive important curative treatments," said Dr. Debra Birnkrant, director of the FDA's Division of Antiviral Products at the Center for Drug Evaluation and Research.
"Chronic hepatitis C, or HCV, is a viral disease that causes inflammation of the liver that can lead to serious liver problems if left untreated. Hepatitis C medicines reduce the amount of HCV in the body by preventing it from multiplying and eventually curing a patient of HCV," Birnkrant explained in an agency news release.
Health care providers should continue to prescribe Mavyret, Zepatier or Vosevi as indicated, but should not give these medicines to patients with signs and symptoms of worsening liver function, the agency advised.
Dr. David Bernstein, chief of hepatology at Northwell Health in Manhasset, N.Y., noted that these medications "are safe and effective when properly prescribed."
Bernstein said that "most hepatitis C patients do not have impaired liver function, so these therapies should be safe."
And he added that other hepatitis drugs such as Harvoni and Epclusa are safe for patients with impaired liver function because they do not contain the agent that can threaten liver function.
Patients should not stop taking these medicines without first talking to a health care professional, and those with liver disease should talk with a health care professional about the benefits and risks of the medicines, the FDA said.
In many of the 63 cases, liver failure occurred in patients who should not have been prescribed these medicines, according to the FDA news release.
In some cases, patients had no cirrhosis (liver scarring) or cirrhosis with mild liver impairment, but did have indications of advanced liver disease or risk factors for liver impairment. In most of the patients, symptoms improved after they stopped taking the potent medicines.
© 2020 HealthDay. All rights reserved.
Posted: August 2019
Read this next
TUESDAY, Sept. 8, 2020 -- New hepatitis C medications are allowing people to receive a kidney transplant from a deceased donor who had the liver disease -- a strategy aimed at...
FRIDAY, March 20, 2020 -- Epclusa (sofosbuvir and velpatasvir) received approval for a supplemental application to treat hepatitis C virus (HCV) in children without cirrhosis or...
WEDNESDAY, March 11, 2020 -- People with hepatitis B or C are at greater risk for liver cancer, but a low-dose aspirin a day might significantly lower that risk, a new study...
More News Resources
- FDA Medwatch Drug Alerts
- Daily MedNews
- News for Health Professionals
- New Drug Approvals
- New Drug Applications
- Drug Shortages
- Clinical Trial Results
- Generic Drug Approvals
- Monthly Update Archive
Subscribe to our Newsletter
Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.