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You are here: Home / Medical Devices / Pradaxa / Blood Thinner Antidote Rejected by the FDA

Blood Thinner Antidote Rejected by the FDA

September 7, 2016 By Sandra Dalton Leave a Comment

Next-generation blood thinners are marketed as easier to use, more convenient, and even safer than warfarin, the old stand-by. But they carry a risk that is not advertised. They can cause uncontrollable bleeding. Until October, 2015, there was no antidote for these medications. Then, Praxbind (idarucizumab) was approved to reverse the effects of Pradaxa (dabigatran). In August, 2016, the U.S. Food and Drug Administration (FDA) rejected a drug that would reverse the action of the remaining next generation blood thinners.

Keeping Pradaxa on Top

Pradaxa was the first next generation anticoagulant to hit the market, as well as the first to have a reversal agent. AndexXa (andexanet alfa) would serve as the antidote to all of Pradaxa’s competitors:

  • Xarelto (rivaroxaban)
  • Eliquis (apixaban)
  • Savaysa (edoxaban)

AndexXa is made by Portola Pharmaceuticals. Chances are, it will eventually be approved, once Portola can satisfy the FDA. Until then Pradaxa maker Boehringer Ingelheim (BI) will profit from being the only one with an antidote.

Next generation blood thinners do have some advantages over warfarin. They do not carry the dietary restrictions, for instance. But many doctors have been afraid to prescribe them because there was no way to stop major bleeding events if they occurred. Emergency room doctors were helpless against these drugs and patients could bleed out long before the drugs were out of their systems. Praxbind gave Pradaxa an immediate edge over the other drugs.

If you or someone you love has been harmed by a dangerous blood thinner, please talk to an experienced defective drug attorney right away to learn more about your rights and potential compensation.

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Filed Under: Pradaxa, Xarelto

About Sandra Dalton

With a background as a paralegal, focusing on criminal defense and civil rights, Sandra Dalton launched her freelance writing career in 2000 with a weekly column on Freedom for Suite 101 and pro bono projects for individuals and organizations supporting causes close to her heart. One of her first projects was for the Police Compliant Center writing about police misconduct. Sandra’s legal writing quickly expanded to include personal injury, animal welfare, criminal defense, disability discrimination, family law and much more.

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