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Good News for A-Fib Patients!―FDA Approves Reversal Agent for the NOACs Xarelto and Eliquis

Background: One of the problems for Atrial Fibrillation patients taking anticoagulants is the risk of life threatening or uncontrolled bleeding, particularly if one is injured. Since the introduction of the NOAC anticoagulants, there’s been an increase of hospital admissions and deaths related to bleeding, one of the major complications of anticoagulation.
In the U.S. alone in 2016, there were about 117,000 hospital admissions attributed to factor Xa inhibitor-related bleeding and nearly 2,000 bleeding-related deaths per month. An estimated 4 million people are taking factor Xa inhibitors.

Anticoagulant Reversal Agents

Up to now, only the anticoagulants Pradaxa (dabigatran) and Coumadin (warfarin) had a reversal agent or antidote.

As an example, if you were taking Pradaxa and were injured in an auto accident, doctors in the ER could administer ‘Praxbind’ (idarucizumab), the Pradaxa reversal agent, to stop any uncontrolled bleeding and (probably) save your life.

Many patients with Atrial Fibrillation were put on Pradaxa rather than Xarelto and Eliquis because Pradaxa has had a reversal agent since 2015.

Andexxa: Antidote for Xarelto and Eliquis

Now both Xarelto (rivaroxaban) and Eliquis (apixaban) have the FDA-approved reversal agent Andexxa (Portola Pharmaceuticals) as of May 7, 2018. It probably won’t be available till early June.

Andexxa rapidly and significantly reverses ‘anti-factor Xa’ activity which is the anticoagulant mechanism of both Xarelto and Eliquis.

Should you Switch From Pradaxa?

If you are taking Pradaxa, you may want to discuss with your doctor whether you should switch to another NOAC. (Note: Eliquis tested the best and is the safest of the new anticoagulants. See my article: Pradaxa and the Other New Anticoagulants.)

Are you tolerating Pradaxa well ? Nearly two out of five people (35%) couldn’t― that’s a high rate of adverse reactions. A large number of patients on the 150mg dose of Pradaxa had an increased incidence of gastrointestinal adverse reactions (35%/yr) compared to warfarin (24%/yr). For more see my article: The New Anticoagulants.

Pradaxa’s own fact sheet states common side effects of Pradaxa include:

• Indigestion, Upset Stomach, or Burning
• Stomach Pain

Note: These statements don’t capture the actual human toll—burning throat, roiling intestines, diarrhea, burning anus, lasting intestinal damage, etc. that Pradaxa can produce in some people.

Even if you seem to tolerate Pradaxa well, it may cause permanent GI damage over time.

Anticoagulants are Still Considered High Risk Drugs

FAQs A-Fib afibEven though Xarelto and Eliquis join Pradaxa with an antidote reversal agent, they are all still considered high-risk drugs.

Taking an anticoagulant is not like taking a multi-vitamin.

Anticoagulants work by causing or increasing bleeding. Though they are certainly better than having an A-Fib stroke, they carry their own risks. Read more: Bleeding Risk of Anticoagulants.

Resource for this article
Wending, P. FDA Approves First Factor Xa Inhibitor Antidote, Andexxa. Medscape Medical Nrews, May 4, 2018. https://www.medscape.com/viewarticle/896182
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