Law Offices of Thomas J. Lamb

  • Asbestos & Mesothelioma
  • Benzene Diseases
  • Camp Lejeune Cases
  • Drug Injury
  • Free Case Evaluation
  • About Us

Safety of Hepatitis C Treatment Drugs Called Into Question

January 30, 2017 By Law Offices of Thomas J. Lamb, P.A.


UPDATE:  On February 14, 2017, the FDA released a Black Box warning for these drugs with the following text:

Hepatitis B virus (HBV) reactivation has been reported, in some cases resulting in fulminant hepatitis, hepatic failure, and death.

(2/16/17).


Recently, the safety of the newer hepatitis C treatment drugs — such as Solvadi and Harvoni — is being called into question.  These drugs are known as direct-acting antiviral (DAA) drugs, and come with a steep cost of approximately $1,000 per pill. Here is a list of DAAs currently available in the US:

  • Sovaldi (sofosbuvir) — Gilead Sciences
  • Harvoni (ledipasvir and sofosbuvir) — Gilead Sciences
  • Viekira Pak (dasabuvir and ombitasvir and paritaprevir and ritonavir) — Abbvie
  • Viekira Pak XR (dasabuvir and ombitasvir and paritaprevir and ritonavir) — Abbvie
  • Epclusa (sofosbuvir and velpatasvir) — Gilead Sciences
  • Daklinza (daclatasvir) — Bristol-Myers Squibb
  • Olysio (simeprevir) — Janssen
  • Technivie (ombitasvir and paritaprevir and ritonavir) — Abbvie
  • Zepatier (elbasvir and grazoprevir) — Merck Sharp Dohme

A report issued by the Institute for Safe Medication Practices (ISMP) provided information on the possibility of liver injury, liver failure, and reactivation of hepatitis B in patients who were treated with DAAs such as Solvadi and Harvoni.  This report is based on the adverse drug event reports submitted to the FDA, also known as MedWatch reports. Here is an excerpt from the ISMP QuarterWatch report, which provides details on the number of adverse drug effects that have been reported to the FDA:

The FDA report described 24 cases of hepatitis B reactivation, including 3 cases of acute liver failure, a catastrophic drug adverse event involving damage to the liver so severe that continued survival is threatened. Searching beyond the FDA’s cited cases to review the most recent 12 months’ FAERS data, we identified 524 reported cases of liver failure associated with the drugs, and another 1,058 reports of severe liver injury. In a further 761 cases the adverse event was antiviral failure against the targeted virus. Our data show the need for further investigation into the negative consequences of these expensive and important new drugs.

This WebMD article provides some additional statistics:

The study said about 250,000 people worldwide took the newer drugs in 2015. Among patients treated with the drugs during the year ending June 30, 2016, 524 suffered liver failure, and 165 of those patients died…The study also said the drugs appeared ineffective in 761 patients.

Of note, approximately 90% of the 524 reports linking liver failure to DAAs were submitted to the FDA by health professionals.  While these hepatitis C drugs are still being prescribed at the same rate they have previously been, the FDA findings are staggering, and should be cause for alarm. Thomas J. Moore, senior scientist for drug safety and policy at ISMP is quoted as saying the following in a recent Healio article:

This is an example of the price we pay for faster drug approval with reduced clinical testing…Don’t we really want to know more than this about a new drug treatment on which we spent more than $10-20 billion in 2015 alone? We spent more than twice as much on these direct-acting antivirals for about 250,000 patients as the NIH did on all research into all infectious diseases.

The FDA identified the first new major safety problem linked to these nine new DAAs in their Drug Safety Communication from October of 2016.  They found that these drugs were linked to the reactivation of hepatitis B, with severe health consequences such as liver transplant and death.  As a result, they expressed their intention to include a “black-box warning,” the most prominent warning, in the near future. However, as of today, January 27, 2016, the current drug label for Harvoni still does not include this warning. We will continue to monitor the medical literature for additional information on the link between these hepatitis C drugs and their harmful side effects.  We will also be on the lookout for the new drug labels with the “black-box” warning of possible hepatitis B recurrence. In the meantime, please feel free to complete our Free Case Evaluation if you have experienced liver injury, liver failure, or hepatitis B recurrence after using one of the nine newer hepatitis C drugs.   Written by: Heather Helmendach, Legal Assistant Law Offices of Thomas J. Lamb, P.A.

Drug Injury Watch: Side Effects News & Reports

Drug Injury Law: Medical & Legal Information

Filed Under: Uncategorized Tagged With: daclatasvir, Daklinza, dasabuvir, direct-acting antiviral drugs, drug injury, drug side effects, elbasvir, Epclusa, grazoprevir, Harvoni, hepatitis b reactivation, hepatitis c treatment drugs, Institute for Safe Medication Practices, lawsuits, ledipasvir, liver damage, liver failure, liver injury, Olysio, ombitasvir, paritaprevir, ritonavir, simeprevir, sofosbuvir, Sovaldi, Technivie, velpatasvir, Viekira Pak, Zepatier

Find What You Want Here

Get Free Case Evaluation

We encourage you to submit an online Case Evaluation Form – it is confidential and there is no obligation.

Or call our toll-free number, 800-426-9535, to speak directly to attorney Tom Lamb about your possible case.

Feel Free To Contact Us

Quick Contact Form
 
Send an Email to Tom Lamb

(800) 426-9535

Main Navigation Menu

  • About Our Firm
  • Asbestos-Mesothelioma Cases
  • Benzene Disease Claims
  • PFAS Firefighter Gear Lawsuits
  • Camp Lejeune Cases
  • GenX Water Cancer Cases
  • Drug Injury Lawsuits
  • Breast Implant Cancer Cases
  • Philips Breathing Devices Cases
  • Case Evaluation Menu
  • Quick Contact Form
  • Frequently Asked Questions
  • Medical Records Charges
  • Collection of Articles
  • Sitemap

Lamb Law Office Newsletter

Lamb Law Office Newsletter provides periodic updates about some of the cases that we are working on for clients, as well as an information resource you might find helpful.

Subscribe using Form below.

Subscription Form

* indicates required

Our Other Websites

Drug Injury Law
Drug Injury Watch
Drug Safety Developments
Asbestos & Mesothelioma

Contact Information

Law Offices of Thomas J. Lamb, P.A.
1908 Eastwood Road, Suite 225
Wilmington, North Carolina 28403
910-256-2971 | 800-426-9535
TJL@LambLawOffice.com

  • Home
  • Frequently Asked Questions
  • Disclaimer and Copyright Notices

Copyright © 2023 · Law Offices of Thomas J. Lamb, P.A.