Did you know this version of Internet Explorer is out of date?

To get the latest experience from our website, please upgrade your browser.

Have a drug or medical device concern?

call 888-646-1884

Pradaxa FDA News

Because Pradaxa is associated with a risk of uncontrollable bleeding, the manufacturer has taken steps to try and find an antidote. The FDA has issued updates regarding these adverse events and potential dangers to patients.

Jump To Topic

On December 7, 2011 The U.S. Food and Drug Administration (FDA) is evaluated post-marketing reports of serious bleeding events in patients taking Pradaxa (dabigatran etexilate mesylate).

Pradaxa Adverse Bleeding Events

There was a concern with the issue of bleeding. This warning was accompanied by instructions for both patients and prescribers to monitor the occurrence of any abnormal bleeding.

In November of 2012, The FDA issued a Safety Announcement stating that it continues to evaluate bleeding and adverse events in patients taking Pradaxa.

In December of 2012, the FDA published another safety announcement regarding the use of Pradaxa in patients who have had heart valve replacement, stating that patients with mechanical prosthetic heart valves should not use the drug.

Pradaxa and Xarelto Bleeding Antidotes

In the race to find an antidote for anticoagulants, there are two primary players. Boehringer Ingelheim, the maker of Pradaxa, is working on its own product. Meanwhile, a small company called Portola is developing another drug that could serve as an antidote for Factor Xa inhibitors like Xarelto, Eliquis (apixaban), and Lixiana (edoxaban).

When Pradaxa (dabigatran etexilate) came to market in 2010, it was hailed as an improvement over warfarin – a popular anticoagulant – because it allegedly could help prevent strokes and was easier to manage than warfarin. 1 One problem: If you take Pradaxa and have a serious bleeding episode, the drug’s anticoagulant effects can’t be reversed. 2 The same is true of Pradaxa’s three main competitors, including Xarelto (rivaroxaban).

In the race to find an antidote for anticoagulants, there are two primary players. Boehringer Ingelheim, the maker of Pradaxa, is working on its own product. Meanwhile, a small company called Portola is developing another drug that could serve as an antidote for Factor Xa inhibitors like Xarelto, Eliquis (apixaban), and Lixiana (edoxaban).

Even though Pradaxa, Xarelto, and their rivals all belong to the same anticoagulant drug class, Pradaxa works differently from the others. Essentially, Pradaxa is marketed to stop thrombin from working after it’s formed, whereas Xarelto, Eliquis, and Lixiana are meant to take effect earlier in the process by inhibiting Factor Xa, an enzyme that facilitates the coagulation process. 3 4 5

Because of this small but important difference, Boehringer is sinking major research and development funds into developing its own reversal agent. In the meantime, Portola has free reign to develop its own antidote that will work with the other three drugs.

Boehringer RE-VERSE Ad Trial

As for which company will produce a working antidote first, it’s still up in the air. Boehringer started the RE-VERSE AD trial – the company’s first Phase 3 trial for a Pradaxa antidote – in May 2014, and it’s expected to run through at least July 2017. 6 Meanwhile, Portola completed one Phase 3 study on its Factor Xa antidote just this past November, and has been running another Phase 3 trial since May. 7

In June 2014, the FDA granted Pradaxa’s antidote breakthrough status, meaning the FDA will fast-track its review. 8 Breakthrough status also carries industry weight that could potentially help boost sagging sales. 9

Regardless of which company goes to market first, however, the outcome will likely be a win-win for both the company and the patients served.

  1. Pierson, Randsell and Bill Berkrot. “Pradaxa antidote works fast, completely in small trial.” Reuters. Nov. 8, 2013. Accessed Dec. 23, 2014. 

  2. Vascular Medicine Department, University Hospital, UJF-Grenoble. “Management of major bleeding complications and emergency surgery in patients on long-term treatment with direct oral anticoagulants, thrombin or factor-Xa inhibitors: Proposals of the Working Group on Perioperative Haemostasis (GIHP) — March 2013.” Arch Cardiovasc Dis. 2013 Jun-Jul;106(6-7):382-93. doi:10.1016/j.acvd.2013.04.009 June 25, 2013. Accessed Dec. 23, 2014. 

  3. Pradaxa package insert. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals Inc. 2014. Accessed Dec. 23, 2014. 

  4. Xarelto package insert. Titusville, NJ: Janssen Pharmaceuticals. 2014. Accessed Dec. 23, 2014. 

  5. Eliquis package insert. Princeton, NJ: Bristol-Myers Squibb Pharma Company. 2014. Accessed Dec. 23, 2014. 

  6. “ANNEXA-A: Antidote reversed anticoagulant effect of apixaban.” Healio. Dec. 15, 2014. Accessed Dec. 17, 2014. 

  7. “Portola.” ClinicalTrials.gov. Accessed Dec. 23, 2014. 

  8. Boehringer Ingelheim’s Investigational Antidote for Pradaxa (dabigatran etexilate mesylate) Receives FDA Breakthrough Therapy Designation.” Ridgefield, CT: Boehringer Ingelheim. June 26, 2014. Accessed Dec. 21, 2014. 

  9. Helfand, Carly. Boehringer’s Pradaxa fights to regain ground with new clot-fighting approval. FiercePharma. April 8, 2014. Accessed Dec. 21, 2014.