Some Xarelto And Eliquis Lawsuits Accuse Drug Makers Of Failing To Warn That In Event Of Uncontrollable Bleeding There Is No Antidote, Just Like With Savaysa
(Posted by Tom Lamb at DrugInjuryWatch.com)
The headline of a recent medical news report about Savaysa (edoxaban), from Daiichi Sankyo, made it seem that there are no serious problems with the use of this still relatively new non-vitamin K antagonist oral anticoagulant.
Published June 20, 2016 by Healio - HemOnc Today, "Edoxaban safe, effective for extended prevention of recurrent VTE" starts out with this apparent ringing endorsement:
Extended treatment with the oral anticoagulant [Savaysa (edoxaban)] prevented recurrent venous thromboembolism and led to fewer major bleeding events than warfarin among patients with venous thromboembolism, according to a post-hoc analysis of a randomized trial.
For what it is worth, I want to point out that Daiichi Sankyo funded this study.
But more interesting, I think, is how this Healio - HemOnc Today news reports ends, focusing on the continuing lack of any FDA-approve antidote for Savaysa, as well as Eliquis and Xarelto.
The growing availability of agents for the reversal of bleeding caused by direct oral anticoagulants suggests that they can be used regularly and safely, Jerrold H. Levy, MD, FAHA, FCCM, professor of anesthesiology and co-director of the cardiothoracic ICU at Duke University School of Medicine, and Beverley J. Hunt, MD, FRCP, FRCPath, professor of thrombosis and hemostasis and director of the hemostasis research unit at Guy’s & St. Thomas’ NHS Foundation Trust in London, wrote in an accompanying editorial.
“For dabigatran [Pradaxa, Boehringer Ingelheim]-treated patients, idarucizumab [Praxbind, Boehringer Ingelheim], a monoclonal antibody that binds dabigatran and acutely reverses its anticoagulation effect, is currently approved for major bleeding or for patients requiring emergency procedures, and is available in many countries,” Levy and Hunt wrote. “For the reversal of the Xa inhibitors [e.g., Savaysa, Eliquis, and Xarelto], andexanet [Portola Pharmaceuticals] and ciraparantag [PER977, Perosphere] are under investigation for acute bleeding episodes.”
Levy and Hunt suggest considering specific reversal strategies when deciding which anticoagulant to use.
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Concerning where things currently stand with the Factor Xa inhibitor anadexanet alfa, we have this information from the Portola website (accessed 6/30/16):
- We filed a Biologics License Application, or BLA, to the FDA in the first quarter of 2016. The BLA is subject to review under an Accelerated Approval pathway with a Prescription Drug User Fee Act, or PDUFA, date of August 17, 2016. The PDUFA date is the goal date for the FDA to complete its review of the BLA.
- Currently being studied in ANNEXA-4, a Phase 3b/4 single-arm, open-label confirmatory study in patients receiving [Eliquis (apixaban)], [Xarelto (rivaroxaban)], [Savaysa (edoxaban)] or enoxaparin (a low molecular weight heparin and indirect Factor Xa inhibitor) who present with an acute major bleed.
As regards the current status of the other proposed antidote, ciraparantag, from the Perosphere website (accessed 6/30/16) we get the following:
Currently in Phase 2 clinical trials, ciraparantag has demonstrated that a single bolus i.v. injection produces complete and sustained reversal of Daiichi Sankyo’s SavaysaTM/Lixiana® (edoxaban) and Sanofi’s Lovenox® (enoxaparin sodium injection) without rebound anticoagulation. Furthermore, no pro-coagulant signal has been observed, as measured by D-dimer, F1.2, TFPI or whole blood clotting time in clinical trials. Non-clinical studies have demonstrated reversal of all approved NOACs including Daiichi Sankyo's SavaysaTM/Lixiana® (edoxaban), Boehringer Ingelheim's Pradaxa® (dabigatran etexilate), Johnson & Johnson and Bayer's Xarelto® (rivaroxaban), and Bristol-Myers Squibb and Pfizer's Eliquis® (apixaban).
Some doctors are apprehensive about the continuing lack of an FDA-approved antidote for Savaysa, Eliquis, and Xarelto, given the severe and sometimes fatal injuries that users of these drugs can sustain if not administered an antidote. As a result of such injuries that have already occurred, drug injury lawsuits are currently being filed against the responsible drug companies
Over the past couple of years, thousands of Xarelto cases have been filed against Johnson & Johnson and Bayer; some including the allegation that these drug makers failed to adequately warn doctors and patients that Xarelto can cause uncontrollable bleeding for which there is no antidote.
More recently, Eliquis lawsuits have started to be filed against Bristol-Myers Squibb and Pfizer, with some accusing these pharmaceutical companies of touting Eliquis as safe and effective, while hiding or obscuring the risk of serious bleeding events and failing to sufficiently warn that there is no antidote to the anticoagulant effect of Eliquis.
Given these parallels, one expects that Savaysa lawsuits filed against Daiichi Sankyo are likely to follow in the near future.
We will continue to monitor developments concerning the andexanet and ciraparantag drugs which would serve as reversal agents for Xarelto, Eliquis, and Savaysa, as well as the drug injury lawsuits regarding this set of blood thinners.
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