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Janssen Research & Development Submits XARELTO® (rivaroxaban) to U.S. FDA for the Treatment and Prevention of Recurrent Venous Thromboembolism
Date:5/2/2012

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WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT XARELTO®?

For people taking XARELTO® for atrial fibrillation:
People with atrial fibrillation (an irregular heart beat) are at an increased risk of forming a blood clot in the heart, which can travel to the brain, causing a stroke, or to other parts of the body. XARELTO® lowers your chance of having a stroke by helping to prevent clots from forming. If you stop taking XARELTO®, you may have an increased risk of forming a clot in your blood.

  • Do not stop taking XARELTO® without talking to the doctor who prescribes it for you. Stopping XARELTO® increases your risk of having a stroke or forming blood clots in other parts of your body. 

If you have to stop taking XARELTO®, your doctor may prescribe another blood thinner medicine to prevent a blood clot from forming.

For all people taking XARELTO®:

  • XARELTO® can cause bleeding which can be serious, and rarely may lead to death. This is because XARELTO® is a blood thinner that reduces blood clotting.  While you take XARELTO® you are likely to bruise more easily and it may take longer for bleeding to stop.

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®)

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SOURCE Janssen Research & Development, LLC
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