I think it is interesting how this recent Healio – HemOnc Today news reports, “Edoxaban safe, effective for extended prevention of recurrent VTE”, ends by 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.
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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