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FDA Does Not Approve Possible Xarelto Antidote

Ever since the first Xarelto lawsuit was filed in 2014, plaintiffs around the country have pointed out that the anticoagulant Xarelto has a major flaw: the fact that there is no antidote for the drug. This means, that ever since 2011 when Xarelto was first released onto the market, doctors have been unable to reverse the effects it has on the blood.

Why Is It Dangerous To Not Have An Antidote?pill-form-of-xarelto-antidote-that-was-rejected

The purpose of blood thinners is to prevent the blood from clotting. Doctors frequently prescribe this type of drug after a surgery or if the patient has a history of blood clots. While not being able to form life-threatening blood clots is a good thing, it also means that the blood is less likely to form life-saving blood clots if the patient is injured and begins to bleed.

If a patient begins to bleed out, whether it be internally or externally, a doctor’s only choice is to perform a blood transfusion and hope that new, untreated blood will clot.

Before Xarelto, older blood thinners like Warfarin came with their own risks, however, if unexpected bleeding occurs, doctors can administer Vitamin K and reverse the anticoagulant effects.

Why Was The Antidote Not Approved?

The antidote, AndaxXa, which is developed and manufactured by Portola Pharmaceuticals, was expected to be approved by the U.S. Food and Drug Administration by the end of the year. In fact, the FDA had initially approved the drug as a breakthrough therapy since the first studies showed promising results and there are no other approved antidotes available. But recently, Portola Pharmaceuticals announced that they had received a letter from the FDA that AndaxXa informing them that the administration had not granted approval.

Portola will have the opportunity to resubmit their application once they provide the FDA with certain information, specifically on how the antidote is manufactured and also an explanation as to why edoxaban and enoxaparin had been included.

How Can A Drug Be Sold Without An Antidote?

If the U.S. Food and Drug Administration approves a drug, the manufacturer does not need to provide an antidote. In Xarelto’s case, the FDA approved the blood thinner in 2011.

Why Hasn’t The Drug Been Recalled?

With thousands of lawsuits filed against GlaxoSmithKline and the formation of MDL 2592, many plaintiffs are wondering why the FDA hasn’t issued a recall for Xarelto. Unfortunately, the other blood-pressure-of-xarelto-patientparty that can answer that question is the administration and while they haven’t issued a recall, they have taken steps to warn both the medical community and the public of the risks associated with taking the drug. The FDA has:

  • Issued an Adverse Reaction Report which indicated that using the drug could result in thrombocytopenia – a side effect condition causing the body to have a low platelet count.
  • A “black box” warning was issued, saying that there was evidence that Xarelto could cause serious injury if a patient who is on the drug undergoes a spinal procedure or trauma to the spine occurs.
  • A warning was released, informing the medical community that if a patient was bleeding excessively, a blood transfusion was the recommended course of treatment as an antidote does not exist.
  • A second “black box” warning was released, regarding the fact that patients who discontinue Xarelto too quickly are at risk for forming blood clots.

Despite this, Xarelto is still the most widely prescribed blood thinner on the market today and lawsuits are still being filed by patients or the loved ones of patients who were harmed by the drug.

What Is An MDL?

MDL stands for Multidistrict Litigation. It is when there are so many lawsuits filed against a defendant, each one alleging a similar issue, that the Judicial Panel on Multidistrict Litigation consolidates the federally-filed lawsuits to one court under one judge. In this case, Xarelto lawsuits have been moved to the Eastern District for Louisiana under Judge Eldon Fallon.

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