For many years, the blood thinner Xarelto has been prescribed to stop blood clots and improve blood circulation, but for some patients, it comes with an increased risk of uncontrolled bleeding. To counteract this bleeding side effect, pharmaceutical manufacturers developed Andexxa as a Xarelto antidote. Andexxa has proven to be an effective Xarelto reversal agent, and as the only known “antidote” for potentially fatal bleeding caused by Xarelto and another popular blood thinner, Eliquis, has saved many lives and has the potential to save many more. However, due to the extremely high dollar cost of Andexxa, many hospitals have chosen not to make this unique life-saving drug available to patients. When hospitals put their financial bottom line over patient safety and judge preventable fatalities to be nothing more than the “cost of doing business,” the people whose lives are in the balance have the right to take legal action.

If you or a loved one were denied access to Andexxa after suffering uncontrollable bleeding while taking Xarelto or Eliquis, we invite you to contact Showard Law Firm today for a free consultation. All initial consultations are free, so you have nothing to lose by calling our firm today.

Xarelto Reversal and Andexxa

Xarelto is a brand name for rivaroxaban. The United States Food and Drug Administration first approved Xarelto in 2011 for the treatment of blood clots in patients who were undergoing hip or knee surgery. Over the next seven years, the FDA approved the expanded use of the drug to reduce the risk of strokes in patients who had irregular heartbeats, to lower recurrent blood clotting problems, and to minimize cardiovascular events in patients with heart and arterial diseases.

Some patients who were using Xarelto on a long-term basis experienced uncontrolled bleeding episodes that did not respond to standard medical treatment. The FDA approved Andexxa for use as a Xarelto reversal agent in May 2018. Andexxa is administered intravenously in a hospital setting, typically for up to two hours.

Xarelto prevents blood from clotting by inhibiting the function of an enzyme known as Factor Xa. Andexxa mimics the Factor Xa molecule and acts as a decoy for substances, like Xarelto, that inhibit the Factor Xa clotting mechanism.

Patients Have Limited Access to Xarelto Antidote

Following Andexxa’s approval by the FDA, the drug’s manufacturer announced that it would make only limited supplies of the rivaroxaban antidote available to a number of hospitals for six months and that it would expand that availability through 2019.

Alternatives to Andexxa?

Xarelto and many earlier-generation blood thinners, including Warfarin, can cause serious bleeding issues that require emergency room treatment. Physicians have used frozen plasma and other antidotes such as KCentra to stem that bleeding. But because these traditional anti-bleeding treatments do not fully address the mechanism by which blood thinners inhibit the clotting function of Factor Xa molecules, patients may continue to experience life-threatening hemorrhages. Andexxa is the only Xarelto reversal agent that directly intervenes in the process by which Xarelto inhibits blood clotting.

Who Is Eligible to File a Lawsuit?

If you or a loved one experienced any of the following circumstances as a result of being denied access to Andexxa by a hospital or other medical facility, you may have a strong case for damages:

  • You experienced excessive bleeding that resulted in longer hospital stays and lengthy recuperation.
  • Your surgery was canceled or delayed on account of bleeding risks associated with Xarelto, and your medical condition grew worse as a result of that delay or cancellation.
  • You were forced to curtail your daily activities due to concerns over bleeding following your use of Xarelto and your treating physician’s reluctance to use Andexxa.

In extreme cases where hemorrhages lead to a fatality, the patient’s family might have a valid cause of action for wrongful death.

Were You Denied the Xarelto Antidote? Call Showard Law Firm

At Showard Law Firm, we have the knowledge and experience to challenge hospitals and medical centers over their nonuse or misuse of Andexxa to reverse the course of excessive bleeding. We believe that patients who have suffered excessive bleeding problems due to their use of Xarelto should not suffer further injuries when an effective remedy is available.

Please call today to consult with an attorney who will provide a thorough and confidential analysis of your case. All initial case reviews are free of charge and come with no obligations to contract our services.

Additional Resources:

  1. apsf.org: New Factor Xa Inhibitor (Xarelto) (Eliquis) Reversal Agent. https://www.apsf.org/news-updates/new-factor-xa-inhibitor-xarelto-eliquis-reversal-agent/
  2. drugs.com: Xarelto Approval History. https://www.drugs.com/history/xarelto.html
  3. chemdiv.com: Portella’s Andexxa Bleeding antidote Receives FDA Nod but Will See Limited Release. http://www.chemdiv.com/portolas-andexxa-bleeding-antidote-wins-fda-nod-will-see-limited-release/