Doctors & patients are saying about 'A-Fib.com'...

"A-Fib.com is a great web site for patients, that is unequaled by anything else out there."

Dr. Douglas L. Packer, MD, FHRS, Mayo Clinic, Rochester, MN

"Jill and I put you and your work in our prayers every night. What you do to help people through this [A-Fib] process is really incredible."

Jill and Steve Douglas, East Troy, WI

“I really appreciate all the information on your website as it allows me to be a better informed patient and to know what questions to ask my EP.

Faye Spencer, Boise, ID, April 2017

“I think your site has helped a lot of patients.”

Dr. Hugh G. Calkins, MD Johns Hopkins,
Baltimore, MD

Doctors & patients are saying about 'Beat Your A-Fib'...

"If I had [your book] 10 years ago, it would have saved me 8 years of hell.”

Roy Salmon, Patient, A-Fib Free,
Adelaide, Australia

"This book is incredibly complete and easy-to-understand for anybody. I certainly recommend it for patients who want to know more about atrial fibrillation than what they will learn from doctors...."

Pierre Jaïs, M.D. Professor of Cardiology, Haut-Lévêque Hospital, Bordeaux, France

"Dear Steve, I saw a patient this morning with your book [in hand] and highlights throughout. She loves it and finds it very useful to help her in dealing with atrial fibrillation."

Dr. Wilber Su,
Cavanaugh Heart Center, Phoenix, AZ

"...masterful. You managed to combine an encyclopedic compilation of information with the simplicity of presentation that enhances the delivery of the information to the reader. This is not an easy thing to do, but you have been very, very successful at it."

Ira David Levin, heart patient,
Rome, Italy

"Within the pages of Beat Your A-Fib, Dr. Steve Ryan, PhD, provides a comprehensive guide for persons seeking to find a cure for their Atrial Fibrillation."

Walter Kerwin, MD, Cedars-Sinai Medical Center, Los Angeles, CA

Drug Watch: FDA Approves Reversal Agent Praxbind® for the Anticoagulant Pradaxa

Published October 26, 2015

The FDA granted “accelerated approval” to Praxbind^®, a reversal agent (antidote) to Pradaxa^®. Praxbind is given intravenously to patients who have uncontrolled bleeding or require emergency surgery.

The accelerated approval program is designed to provide patients with earlier access to new drugs.

Pradaxa (dabigatran), a novel oral anticoagulant (NOAC), reduces the risk of clots and stroke in patients with Atrial Fibrillation. The new NOACs are alternatives to warfarin (Coumadin).

Patients on Pradaxa Were Bleeding to Death in the ER

Patients on Pradaxa have been bleeding to death in the ER while doctors were powerless to stop their bleeding and could only watch them die. See Stop Prescribing or Taking Pradaxa.

Praxbind®, reversal agent for Pradaxa®

In clinical trials, 5gs of Praxbind (idarucizumab) reversed the anticoagulant effect of Pradaxa within minutes (which is significantly faster than the current antidotes for warfarin). In one ongoing trial, the anticoagulant effect of Pradaxa was fully reversed in 89% of patients within four hours. This effect lasted at least 24 hours.

Praxbind works by binding to Pradaxa to neutralize its effect (measured as unbound Pradaxa plasma concentration). The most common side effects of Praxbind were headache, low potassium, confusion, constipation, fever and pneumonia.

Boehringer Ingelheim (a privately-held German company), which manufactures both Pradaxa and Praxbind, will be required to submit additional clinical information after approval to confirm the clinical benefit of Praxbind.

After Praxbind, Get Back on Anticoagulants ASAP!

Boehringer Ingelheim recommends that patients resume their anticoagulant therapy as soon as medically appropriate. In the clinical trials of Praxbind, five patients suffered strokes after reversal. They were not receiving anticoagulant therapy at the time of their stroke.

Other NOACs Will Soon Have a Reversal Agent

Pradaxa was the first NOAC to win FDA approval, but now there are three other new anti–blood clotting drugs available to doctors and patients.

Despite its newly approved reversal agent, Pradaxa’s advantage over the other NOACs will probably be short lived.

• Xarelto® (rivaroxaban) by Bayer Pharma/Janssen Pharmaceuticals
• Eliquis® (apixaban) by Pfizer/Bristol-Meyers Squibb (tested the best with the best safety record)
• Lixiana®/Savaysa® (edoxaban) by Daiichi-Sankyo (newest NOAC to be approved by the FDA)

The other NOACs will soon have a reversal agent, Andexanet Alfa, which has done well in clinical trials and is also on fast track FDA approval. It’s being developed by Portola Pharmaceuticals.

Despite its newly approved reversal agent, Pradaxa’s advantage over the other NOACs will probably be short lived.

Added 5/17/21:

Praxbind appears to work in intracranial hemorrhage (ICH) as well.

References for this article

FDA approves Praxbind, the first reversal agent for the anticoagulant Pradaxa. US Food and Drug Administration, FDA News Release, October 16, 2015. URL: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm467300.htm

Idarucizumab immediately reverses anticoagulant effect of dabigatran in AF patients. Cardiac Rhythm News, Issue 30, October 2015, p. 1. URL: http://www.cxvascular.com/crn-newspapers-pdfs. Download issue at: http://bit.ly/1hYcWDd

Phend, Crystal. Intracerebral hemorrhage subgroup showed rapid reversal in RE-VERSE AD trial. MedPge today, February 23, 2016. https://www.medpagetoday.com/clinicalfocus/atrialfibrillation/59079