Living with Atrial Fibrillation

Providing Knowledge, Inspiration and Support for Afibbers

Providing Information, Inspiration and Support for Afibbers
  • Home
  • Ablations
    • Read This Before You Have an Ablation!
    • Second Guessing Your Upcoming Ablation
    • My Second A-Fib Ablation Experience
    • My Second A-Fib Ablation Recovery
    • My First A-Fib Ablation Experience
    • My First A-Fib Ablation Recovery
  • Cardioversions
  • Natural Treatments
    • Best Diets for Afib
    • Magnesium and Afib
    • Potassium and Afib
    • Treating Sleep Apnea for Afib
    • Chiropractic Treatment for Afib
  • Reviews
    • AliveCor Kardia Monitor Review
    • My Life Line Screening Review
    • YouDrugStore.com Review
    • ReMag Magnesium Review
  • About
    • Contact
  • Donate
You are here: Home / Blood Thinners / Is The Risk of Bleeding From Pradaxa The FDA's Fault?

Is The Risk of Bleeding From Pradaxa The FDA's Fault?

Travis Van Slooten |March 14, 2014 | 2 Comments

On the surface, Pradaxa seems to have a lot of benefits that make it an ideal choice over its older cousin, Warfarin. But it hasn’t replaced Warfarin altogether because of the high rate of excessive bleeding that comes along with the drug.

Both drugs do have that risk. But Warfarin has countermeasures which Pradaxa lacks. And doctors can reduce the dosage for Warfarin patients to try to reduce the risks.

The FDA’s decisions did prevent Pradaxa users from pursuing a similar solution.

Even if a patient appears at higher risk of bleeding with Pradaxa, clinicians currently have no option for reducing the dose. In most advanced countries, in addition to the available 150 mg strength, there’s a 110 mg dose available, and recommended for use in patients age 80 and over and those with risk factors. But the FDA disallowed this lower dose here. A 75 mg dose has been approved, but only for use in patients with severe kidney disease.

An additional perspective on this safety problem recently emerged with two studies published in the American Journal of Cardiology and documents reported in the news media. These found that in many older patients, the lower 110 mg dose of Pradaxa is just as effective as the higher dose, but lowered the bleeding risk.

–Philly.com

The lower dose is available in other countries, so why is the FDA dragging its feet on this? It’s not like Canada, Australia, and European nations are ignorant backwaters whose medicine can’t be trusted.

What do you think? Do you think the FDA is in the wrong here, or is there reason for caution?

Share this article with others

Stay Up To Date on A-Fib

Get notified when blog posts like this get published!

We respect your email privacy.

Discuss this Article

Click here to start your own discussion topic or reply to any comments below by clicking on the "REPLY" buttons.
  1. Mellanie True Hills
    Mar 14, 2014

    Travis,

    The lower dosage approved by the FDA is used for older patients as well as those with kidney issues. In fact, the FDA’s modeling showed the 75 mg dosage to be a better choice than the 110 mg dosage for patients that needed a lower dosage.

    Mellanie True Hills

    Reply
    • Travis
      Mar 14, 2014

      Thanks for the clarification, Mellanie!

      Travis

      Reply

Discuss this Article Cancel reply

What are these optional fields for?You are not required to enter your age, gender, or years with afib but the information may help other readers put your comments in context. For example, if you are a 50 year old male that has only had afib for 1 year, your comments will have different meaning to someone that is 65, female, and has had afib for 15 years.

Stay Up To Date on A-Fib

Get notified when new content is published!

We respect your email privacy.

Search

Most Popular Posts

My Second A-Fib Ablation Experience

My Second A-Fib Ablation Recovery

Potassium and Atrial Fibrillation

Magnesium and Atrial Fibrillation

Emergency! How to Stop an Afib Attack

Categories

  • Blood Thinners
  • Causes of Atrial Fibrillation
  • Celebrities with Afib
  • Miscellaneous
  • My Afib Journey
  • Natural Treatments
  • Personal Afib Stories
  • Product Reviews
  • Questions and Answers
  • Traditional Treatments

About Me

I was diagnosed with atrial fibrillation on Father's Day in 2006. I didn't know it then but that diagnosis would change my life forever. Read More

Accolades

  

Help Support this Site

Help to keep this site free from ads! Please consider a donation to help pay for hosting and maintenance.

100.00
81
Important Health Disclaimer: Do not follow any of the advice on this site without first consulting with your physician! I am not a doctor nor do I play one online. I'm just a guy who has afib that wants to share his opinions and thoughts on afib as well as share information I find interesting regarding this medical condition. The content provided on this site is for educational purposes only and is not intended (nor implied) to be a substitute for professional medical advice. Please read my official legal health disclaimer.

Copyright 2023 – Living with Atrial Fibrillation

  • Home
  • Privacy Policy
  • Affiliate Disclaimer
  • Sitemap