Law Offices of Thomas J. Lamb

  • Asbestos & Mesothelioma
  • Benzene Diseases
  • Drug Injury
  • About Our Firm
  • Free Case Evaluation
  • Frequently Asked Questions

Is Eliquis A Safe Alternative To Warfarin For Patients On Dialysis?

November 3, 2016 By Law Offices of Thomas J. Lamb, P.A.

In this article published online by Pharmacy Times in August 2016, “Is Apixaban Safe and Effective for Patients on Hemodialysis?”, Brandon Dyson, PharmD, BCPS, who is a clinical pharmacist at an academic medical center, puts some scrutiny on Eliquis, an increasingly popular blood-thinner drug:

[Eliquis (apixaban)] is the only [novel oral anticoagulants (NOAC)] approved for use with creatinine clearance <15 mL/min. In fact, according to its package insert, there isn’t even a dose adjustment….

[T]he clinical trials for [Eliquis (apixaban)] didn’t include hemodialysis (HD) patients, but they’re able to recommend [Eliquis (apixaban)] use in HD patients with no dose adjustment. How?

You must dig deep to find the answer. The [Eliquis] package insert mentions a single-dose pharmacokinetic study in HD patients. If you dig a little further, you’ll eventually find it, and you’ll find out it only involved 8 patients….

What happens if you give multiple doses? [Eliquis (apixaban)] dosing is 5 mg BID in most patients. Does it accumulate in HD? We don’t know; it hasn’t been studied.

All we currently have is data from a single-dose trial in 8 patients. And that’s the point I’m trying to make. [Eliquis (apixaban)] may very well be safe and effective in HD, but we don’t actually know. It might be safe, but not effective, or it might be effective, but not safe. It also may be neither.

As for his mention of that eight (8) patient study, he referenced this medical journal article, “Pharmacokinetics, pharmacodynamics, and safety of apixaban in subjects with end-stage renal disease on hemodialysis.”, published in the May 2016 print edition of The Journal of Clinical Pharmacology.

Of course, this clinical pharmacist’s concern about — or skepticism of, perhaps — Eliquis use in the setting of hemodialysis piqued our interest.

The only thing we were able to readily find on-point was this item, “Apixaban in Hemodialysis”, on the ClinicalTrials.gov website, which provided us some rather limited information:

  • This study has been completed.
  • Sponsor: Jewish General Hospital
  • First received: January 12, 2016
  • Last updated: August 29, 2016
  • No Study Results Posted on ClinicalTrials.gov for this Study

So, it seems, there is not much publicly available data about the safety of using Eliquis in the setting of hemodialysis. Yet, such use was apparently approved by the FDA.

[Read this article in full at original source]

___________________________________________________________

Free Eliquis Case Evaluation

Strictly Confidential, No Obligation

___________________________________________________________

Filed Under: Unsafe Drugs Tagged With: bleeding events, bleeding risk, Eliquis, Gastrointestinal (GI) Bleeds, Uncontrollable Bleeding Events

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
  • Philips Breathing Devices 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 © 2022 · Law Offices of Thomas J. Lamb, P.A.