"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

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Dr. Wilber Su Cavanaugh Heart Center, Phoenix, AZ

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"Steve Ryan's summaries of the Boston A-Fib Symposium are terrific. Steve has the ability to synthesize and communicate accurately in clear and simple terms the essence of complex subjects. This is an exceptional skill and a great service to patients with atrial fibrillation."

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"I love your [A-fib.com] website, Patti and Steve! An excellent resource for anybody seeking credible science on atrial fibrillation plus compelling real-life stories from others living with A-Fib. Congratulations…"

Carolyn Thomas, blogger and heart attack survivor; MyHeartSisters.org

"Steve, your website was so helpful. Thank you! After two ablations I am now A-fib free. You are a great help to a lot of people, keep up the good work."

Terry Traver, former A-Fib patient

"If you want to do some research on AF go to A-Fib.com by Steve Ryan, this site was a big help to me, and helped me be free of AF."

Roy Salmon Patient, A-Fib Free; pacemakerclub.com, Sept. 2013

Stop Prescribing or Taking Pradaxa: Suspect in 542 Patient Deaths

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from Boehringer Ingelheim

by Steve S. Ryan, PhD, April 15, 2013; Updated October 2015

We’ve been reading heart-wrenching stories of people on Pradaxa bleeding to death in Emergency Rooms because there’s no antidote to reverse its blood-thinning effects. Pradaxa was identified as the primary suspect in 542 patient deaths reported to the FDA in 2011, as well as 3,781 serious adverse events.  Pradaxa “was linked to more reports of injury and death than any of the more than 800 drugs regularly monitored by the Institute for Safe Medication Practices.” By comparison, warfarin (Coumadin) was associated with only 72 deaths during that same time period.

People taking Pradaxa were almost 5 times as likely to die from bleeding episodes than those taking warfarin.

Dr. Bryan A. Cotton, a trauma surgeon at Memorial Hermann-Texas Medical Center in Houston has said Pradaxa contributed to the bleeding deaths of at least eight patients at his hospital.

What a horrible way to die. Doctors and nurses in the ER try everything they can think of, but then have to watch as their patient dies from uncontrolled bleeding. How devastating for relatives and friends.

Why in the world would the FDA put blood thinners on the market that have no antidote or reversal agent, where people die because their bleeding can’t be stopped? Warfarin may not be perfect, but ER doctors at least have a fighting chance to stop someone from bleeding to death if they are taking warfarin.

Some doctors who receive consulting fees, etc. from Boehringer Ingelheim (the manufacturer of Pradaxa) are arguing that there was no evidence that the lack of an antidote contributed to the deaths of the Pradaxa takers who bled to death. (Try telling that to the ER doctors who had to watch their patients die from uncontrolled bleeding.)

Another argument is that 542 deaths is a small number compared to the number of people using Pradaxa. But many of these 542 deaths did not have to happen. Many deaths could probably have been prevented if there was a reversal agent like there is with warfarin.


We can’t expect the FDA to take Pradaxa off of the market or put any significant limits or safeguards on its use any time soon. The FDA tends to stand by any drug it approves. It’s embarrassing to them to admit they were wrong. (Some people go so far as to say the Drug Industry has a great deal of influence over the FDA.)

The solution is simple: Stop Prescribing or Taking Pradaxa. Go back to warfarin which isn’t as convenient as the new anticoagulants. But warfarin does work reasonably well if you stay in the proper INR range. And it does have reversal agents.

And there are alternatives to Pradaxa besides warfarin. The FDA has approved the anticoagulants Rivaroxaban (Xarelto) from Bayer & Johnson and Johnson and Apixaban (Eliquis) from Bristol-Meyers Squibb & Pfizer. However, “a European study also showed new blood thinners like Pradaxa can have 55% higher risks for internal bleeding.”

While these new anticoagulants also don’t have reversal agents, there is anecdotal evidence that Xarelto has fewer bleeding deaths than Pradaxa. The recently approved Eliquis tested better and is safer.

Update October 26, 2015: FDA Approves Reversal Agent for Pradaxa (dabigatran) 
In a new study of 90 patients who had uncontrolled bleeding with Pradaxa, Praxbind (idarucizumad) stopped this bleeding within minutes. No serious side effects were reported.
We have previously reported on the reversal agent Andexanet Alfa which is on FDA fast track approval as an antidote to the Factor Xa inhibitors Xarelto and Eliquis. FDA approval is pending.
References for this article

Last updated: Thursday, January 21, 2016

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