Law Offices of Thomas J. Lamb

  • About Our Firm
  • Asbestos & Mesothelioma
  • Benzene Diseases
  • Drug Injury
  • Breast Implants
  • Free Case Evaluation
  • FAQs

Pradaxa Liver Injury: Label Changes Warning About This Increased Risk

July 27, 2018 By Law Offices of Thomas J. Lamb, P.A.

We are watching to see whether the FDA and/or European drug regulators require a Pradaxa liver injury label change adding a new warning about an increased risk of acute liver failure and drug-induced hepatitis — like what was done in Japan last year and is being done now in Canada.

In May 2018 Health Canada announced that their Pradaxa drug safety review evaluating the risk of liver injury associated with Pradaxa concluded that there may be a link. Accordingly, Health Canada is working with the responsible pharmaceutical company to update the Canadian product monograph, or drug label, for Pradaxa (dabigatran) to inform healthcare professionals and patients about this increased risk of liver injury.

In more detail, from this Health Canada document, “Summary Safety Review – PRADAXA (dabigatran etexilate) – Assessing the potential risk of liver injury”:

Safety Review Findings

  • At the time of the review, Health Canada had received 27 Canadian reports of severe liver injury related to the use of Pradaxa. Of these reports, 4 were further assessed as they were suspected to be linked to the use of Pradaxa. 3 of the 4 reports, including 1 death, showed a possible link between liver injury and the use of Pradaxa. [footnote omitted]
  • This review also looked at 105 international reports of severe liver injury related to the use of Pradaxa. Of these reports, 16 were further assessed as they were suspected to be linked to the use of Pradaxa. 13 of these 16 reports, including 2 deaths, showed a possible link between liver injury and the use of Pradaxa.

That relatively recent Health Canada Pradaxa Safety Review document goes on to point out: “The Pharmaceuticals and Medical Devices Agency of Japan issued a risk communication and updated the product label on September 12, 2017 to include liver injury (i.e. ‘acute hepatic failure, hepatic function disorder, and jaundice’).” [footnote omitted].

[View article at original source]

Free Pradaxa Case Evaluation

Strictly Confidential, No Obligation

Filed Under: Unsafe Drugs Tagged With: drug side effects, drug-induced liver injury, liver damage, liver failure, liver injury, Pradaxa

Find What You Want Here

Get Free Case Evaluation

We encourage you to submit an online Case Evaluation Form 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
  • Drug Injury Cases
  • Breast Implant Cases
  • GenX Cancer 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 © 2021 · Law Offices of Thomas J. Lamb, P.A.