Warnings

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Xarelto carries the FDA's strongest warning for dangerous spinal bleeds, which are called epidural or spinal hematomas. These pools of blood collect outside of blood vessels and may cause permanent paralysis in the spine. Patients are at greater risk if the following factors apply:

  • Epidural catheters
  • Drugs affecting the clotting process
  • History of spinal trauma
  • Prior spinal surgery

The warning also cautions against any spinal procedures in patients who take Xarelto. A second warning was issued to notify patients with nonvalvular atrial fibrillation that stopping the medicine may increase the risk of blood clots and strokes.

Here are some additional red flags regarding Xarelto, which became evident soon after the drug was available:
  • In 2011, more than 2,081 Xarelto complaints including at least 151 deaths were submitted to the FDA, according to a report by the Institute for Safe Medication Practices (ISMP). A study during the same year found that Xarelto users are more than twice as likely to experience bleeding compared with patients taking Lovenox.
  • In 2012, Xarelto, Pradaxa and Coumadin were ranked among the most dangerous drugs based on the number of problems reported to the FDA. All three drugs accounted for 1,734 complaints including 233 patient deaths. The most frequent complications included uncontrollable internal bleeding and hemorrhaging.
  • In 2013, the FDA required that Xarelto drug manufacturers include a warning on boxes indicating that premature discontinuation of the drug increases the risk of thrombotic events and spinal/epidural hematoma.

  • In 2014, the following occurred:
  • Bayer AG and J&J pursued approval for additional uses for Xarelto. The drug companies wanted to advertise the drug as a way to prevent new heart attacks, clogging of heart stents strokes and even death. The FDA, however, rejected the request because clinical data did not show sufficient evidence.
  • The FDA required that Xarelto boxes include warnings about the possible side effect of internal bleeding and the lack of an antidote.
  • The ISMP reported that nearly 700 people experienced Xarelto side effects, including bleeding, in the first quarter of 2013. During the same year, German regulators reported that the number of Xarelto deaths rose from 2012.

  • Findings from clinical research and studies also point to the dangers of Xarelto. Here are some of the results:
  • On September 8, 2011, The New England Journal of Medicine published findings from the “ROCKET AF” study. Xarelto was compared with Warfarin to assess its ability to prevent stroke and treat atrial fibrillation. No significant differences in rates of serious or other bleeding problems were found.
  • On April 5th, 2012, The New England Journal of Medicine published results from the “EINSTEIN PE” study. The analysis compared rivaroxaban, a direct Factor Xa inhibitor, and an entirely different anticoagulant and low molecular weight heparin, Enoxaparin Sodium. The study concluded that Xarelto had “superiority for major bleeding” compared with Enoxaparin.
  • On July 12, 2013, MedPage Today published the results from another study from the Erasmus MC University Medical Center in Rotterdam, The Netherlands. Research on the risk of gastrointestinal bleeding compared Xarelto and another drug Pradaxa with warfarin. Patients taking Xarelto had a 1.49 increased risk of internal bleeding versus those using warfarin.
  • On January 16, 2015, Baylor College of Medicine released a study, which Bayer Healthcare and Janssen funded. Published in the Clinical Cardiology. The researchers analyzed 27,467 patients who were taking Xarelto (rivaroxaban) from January 2013 to March 2014. Findings indicated that 478 patients had a serious bleeding problem, and 14 patients died from internal bleeding.
  • On April 24, 2015, an article in the British Medical Journal noted that Xarelto was not a safe medication. Patients treated with this drug showed up to a “twofold higher risk of bleeding,” which could lead to life-threatening events compared with warfarin.
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