There is promising news for the more than 4 million patients who take Xarelto® (Riviaroxaban) or Eliquis® (Aixaban) on a daily basis. These blood thinners, while effective, have been shown to cause uncontrolled and sometimes life-threatening bleeding events. The FDA has finally approved a reversal agent that can stop the anticoagulant effects of Xa inhibitors, in the form of a new drug called Andexxa. Manufacturer Portola Pharmaceuticals estimates that thousands of patients every year will benefit from its development.
Xarelto bleeding antidote approved by the FDA
When uncontrolled hemorrhaging begins, every second counts. Clinical trials have shown that Andexxa rapidly reverses the anticoagulating effects of Xarelto, letting doctors treat catastrophic bleeds. The antidote was approved through the FDA’s accelerated pathway and marks the first drug specific to Xa inhibitors.
Given the surge in Factor Xa inhibitor prescriptions in the United States, and the alarmingly high rate of hospital admissions and fatalities related to irreversible bleeding – Andexxa may well save countless lives. According to recent statistics, 140,000 Americans were admitted to the hospital in 2017 because of Eliquis and Xarelto-related bleeding. Some suffered gastrointestinal bleeds, while others experienced brain hemorrhages requiring transfusions and extensive medical care.
In preliminary Andexxa open-label studies, of the 185 high-risk patients who were given the antidote to treat uncontrolled bleeding, 83 percent recovered within 12 hours. The FDA states that post-market studies on the safety and efficacy of Andexxa will begin this year and continue through 2023. Andexxa is only approved and indicated for bleeding events caused by apixaban or rivaroxaban and does not work with other anticoagulant medications.
Andexxa risks and side effects
Like any prescription medication, Andexxa carries risks of adverse side effects. According to the product labeling, the most common side effects are the development of urinary tract infections and pneumonia. In clinical studies, the reversal agent was also linked to more serious, though rare, side effects including:
- Arterial and venous thromboembolic events such as deep vein thrombosis
- Myocardial infarction
- Cardiac arrest
- Ischemic stroke
- Sudden death
While Andexxa is poised to help countless patients currently taking Xa inhibitors, there are thousands of others who suffered tremendous pain or lost a loved because no antidote was available. Litigation concerning Xarelto side effects continues to play out in state and federal court rooms across the nation.
Litigation and potential settlements for plaintiffs
Unfortunately, Andexxa is not available at many hospitals. Some hospitals have indicated that the cost is too high. If you or a loved one have suffered from a bleeding event at a hospital that chose not to carry Andexxa you may have a claim against the hospital.
Additional Resources on Andexxa:
- org, DA APPROVES ANDEXXA® https://www.stoptheclot.org/news/fda-approves-andexxa/
- DrugTopics, Why a New Anticoagulant Reversal Agent Is Significant https://www.drugtopics.com/anticoagulants/why-new-anticoagulant-reversal-agent-significant
- GlobeNewswire, FDA Approves Portola Pharmaceuticals’ Prior Approval Supplement for Andexxa® Generation 2 Manufacturing Process https://globenewswire.com/news-release/2018/12/31/1679262/0/en/U-S-Food-and-Drug-Administration-Approves-Portola-Pharmaceuticals-Prior-Approval-Supplement-for-Andexxa-Generation-2-Manufacturing-Process.html