Xarelto Approved by the FDA for Atrial Fibrillation Stroke Prevention

By Mellanie True Hills

  • Summary: The FDA has approved a second alternative to warfarin, Xarelto (rivaroxaban), for stroke prevention in atrial fibrillation.
  • Approximate reading time: 2–4 minutes

November 4, 2011 — The U.S. Food and Drug Administration has approved Xarelto (rivaroxaban) to reduce stroke risk in those who have non-valvular atrial fibrillation (afib that is not related to heart valve problems). Xarelto becomes the second oral alternative to warfarin and is considered a good alternative for patients who don’t do well on warfarin or dabigatran.

Xarelto is the first once-a-day alternative to warfarin and should be taken with the evening meal in order to be properly absorbed. The normal daily dose is 20 mg, and for patients with kidney issues (renal impairment), 15 mg.

Xarelto is a “direct factor Xa (pronounced 10a) inhibitor”. Unlike warfarin, which has multiple food and drug interactions and requires frequent clinic visits, blood draws and dose adjustments, rivaroxaban is an oral medication with no reported food or drug interactions.

Back in September, an FDA panel voted 9-2-1 to recommend that the FDA approve rivaroxaban (Xarelto) for stroke prevention in atrial fibrillation despite the FDA staff recommendation against approval. In approving Xarelto, the FDA followed the panel’s guidance.

Approval was based on the results of the ROCKET-AF trial of 14,000 patients comparing Xarelto to warfarin. Xarelto was similar to warfarin in preventing stroke and in major bleeding, though Xarelto caused fewer brain bleeds but more stomach and intestinal bleeds. Uniquely, the ROCKET-AF trial was based on a much higher-risk population than most clinical trials. To learn more about the ROCKET-AF trial, see Rivaroxaban as Effective as Warfarin for Stroke Prevention in Atrial Fibrillation.

The FDA is requiring a Risk Evaluation and Mitigation Strategy (REMS) to communicate about the increased stroke risk from discontinuing Xarelto without starting other anticoagulants and that Xarelto is less effective if it is not taken with the evening meal. The REMS includes a Medication Guide that comes with Xarelto and describes the risks and adverse reactions. Important notes taken directly from the Medication Guide include:

  • Do not stop taking Xarelto without talking to the doctor who prescribes it for you. Stopping Xarelto increases your risk of having a stroke.
  • You may have a higher risk of bleeding if you take Xarelto and take other medicines that increase your risk of bleeding, including:
    • aspirin or aspirin containing products
    • non-steroidal anti-inflammatory drugs (NSAIDs)
    • warfarin sodium (Coumadin, Jantoven)
    • any medicine that contains heparin
    • clopidogrel (Plavix)
    • prasugrel (Effient)
    • ticagrelor (Brilinta)
  • Other medicines are listed that may affect the way Xarelto works.

Also see the Product Information Guide for additional information about Xarelto.


Doctors and patients must now wrestle with which medication is best. The population in the ROCKET-AF trial was older and sicker in general, and took multiple drugs. About half had also had prior strokes. Thus, Xarelto is likely to be considered for patients who mirror that trial population and also for patients for whom warfarin and dabigatran aren’t suitable.

Please note that StopAfib.org does not endorse particular medications, but we do provide you information about new things happening that could impact you. Stroke prevention is the most critical issue for anyone with atrial fibrillation.

For more information about Xarelto, see:

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