FDA says hepatitis C treatment may cause liver damage, patient death: 3 things to know

Two treatments for hepatitis C infections — Viekira Pak and Technivie — may cause serious liver injury in patients with underlying advanced liver disease, according to a recent Food and Drug Administration safety announcement.

Highlighted below are three things to know about the drug and the FDA announcement.

1. The treatments, manufactured by AbbVie, were developed to treat chronic hepatitis C, a viral infection that can last a lifetime and lead to serious health problems or death. Unfortunately, numerous patients either died or had to undergo a liver transplant after receiving the treatment due to complications it caused, according to the announcement.

2. Since December 2014, the FDA has identified at least 26 cases in which patients reported they received Viekira Pak or Technivie and then, roughly four weeks later, experienced severe liver damage. The patients who reported the complications already had cirrhosis of the liver, according to the agency.

3. As a results of the recent discover, the FDA announced it is now requiring the manufacturers to add new information to the drug label about the safety risk.

 

 

More articles on hepatitis C:
Abbvie’s Viekira Pak: $6.5M a year in avoidable costs, and putting patients at greater risk
Managing Hepatitis C: Advances in treatment & evaluation
Hep C infection rates to skyrocket in urban EDs, researchers say

Copyright © 2024 Becker's Healthcare. All Rights Reserved. Privacy Policy. Cookie Policy. Linking and Reprinting Policy.

 

Featured Whitepapers

Featured Webinars