When we read this September 25, 2015 Medscape article, “EMA Recommends Approval of Idarucizumab (Praxbind), a Dabigatran-Specific Antidote”, we recalled this alarming fact: At the present time there is no available antidote for Pradaxa nor Xarelto, Savaysa, and Eliquis such that irreversible bleeding events, which can result in deaths, remain a real and serious safety issue for these newer blood-thinning drugs.
Returning to that recent article, Praxbind will be useful in cases where patients have to undergo emergency surgery or when life-threatening or uncontrolled bleeding occurs when on Pradaxa (dabigatran).
As suggested by that article’s headline, however, Praxbind will only work to stop excessive bleeding associated with Pradaxa, which is a direct thrombin inhibitor. It is not intended for use in patients with acute bleeding while on Eliquis, Savaysa, or Xarelto.
Portola Pharmaceuticals is in the process of developing Andexanet alfa, a reversal agent or antidote for all Factor Xa inhibitors, such as Eliquis, Savaysa, or Xarelto.
So when will Praxbind and Andexanet be approved by the FDA and become available to patients in the US?
And from an August 27, 2015 Portola News Release about the status of Andexanet: “The Company expects to submit a Biologics License Application (BLA) for Andexanet alfa to the FDA under an Accelerated Approval pathway at the end of 2015.”
So while Eliquis, Savaysa, and Xarelto are touted for their ease of use as regards both patient and physician, these FXa inhibitor class anticoagulants have one major drawback in common: There is no antidote.
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