FDA Approves Xarelto Antidote
A new Xarelto antidote, AndexXA, has recently been approved as a reversal agent for Xarelto and Eliquis.
Previously, no Xarelto antidote existed, putting patients at risk of a serious bleeding event. The federal regulators approved the reversal agent after two years of uncertainty and delays.
Xarelto Antidote Could Stop Life-Threatening Bleeds
The Xarelto antidote was called for years ago after many patients came forward with concerns of severe or even deadly bleeding events.
These deadly bleeding events that prompted the creation of a antidote were all tied to side effects of and Eliquis, two anticoagulants that were widely adopted by the medical community until patients began to report developing severe side effects.
The approval of the Xarelto antidote has only come through the U.S. Orphan Drug and FDA Breakthrough Therapy Designation, meaning that further post-marketing studies will be completed to identify the drug’s safety and effectiveness.
Those post market studies will be critical for determining whether or not the antidote stays on the market. This post-marketing requirement involves the use of a clinical trial which isn’t even scheduled to begin until 2019.
The clinical trial for the antidote needs to be completed by 2023 and that is just one year before the patent for expires in 2024.
Initially, Eliquis and Xarelto came on the market as a replacement for the popular medication Warfarin.
The primary purpose of these drugs was to prevent strokes and other problems connected to atrial fibrillation.
Thousands of reports which ultimately led to the development of the Xarelto antidote however, had to do with patients who suffered fatal or severe injuries when those users developed internal bleeding that doctors were unable to reverse or stop.
Warfarin bleeding can easily be reversed with a popular antidote but since was originally introduced in 2011, this is the first time that a Xarelto antidote has been available.
FDA officials have shared concerns about the antidote which could possibly be used by millions of patients who are at risk of severe bleeding events.
One study from 2016 indicating positive results for the antidote has already come under scrutiny by physicians who allege that the researchers who put together that study were overstating the benefits.
More than 20,000 bleeding lawsuits have already been consolidated in a federal multidistrict litigation centralized in Louisiana.
All of these lawsuits are based on similar claims from injured patients that they were never fully warned about the possible risks of taking Xarelto and were left to cope with the consequences of uncontrollable bleeding issues and other critical side effects.
Anyone who has been seriously injured by Xarelto and who may have to consider using the Xarelto antidote in the future should consult directly with an experienced lawyer at McDonald Worley.
The experienced attorneys at McDonald Worley help patients with legal claims when a dangerous drug has caused injuries. Call today for a free case evaluation.
Disclaimer: McDonald Worley is not representing the plaintiff in this lawsuit.