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U.S. FDA Grants Priority Review for XARELTO® (rivaroxaban) to Reduce Secondary Cardiovascular Events in Patients with Acute Coronary Syndrome
Date:2/27/2012

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Call your doctor or get medical help right away if you develop any of these signs or symptoms of bleeding:

  • tingling, numbness or muscle weakness, especially in your legs. This is particularly important if you had a procedure called spinal or epidural puncture as part of your anesthesia during surgery.
  • any unexpected bleeding, or bleeding that lasts a long time (such as nose bleeds that happen often, unusual bleeding from gums, or menstrual bleeding that is heavier than normal or vaginal bleeding)
  • bleeding that is severe or that you cannot control
  • red, pink or brown urine
  • bright red or black stools (look like tar)
  • cough up blood or blood clots
  • vomit blood or your vomit looks like "coffee grounds"
  • headaches, feeling dizzy or weak
  • pain, swelling, or new drainage at wound sites

WHO SHOULD NOT TAKE XARELTO®?

Do not take XARELTO® if you:

  • currently have abnormal or unusual bleeding
  • are allergic to rivaroxaban or any of the ingredients of XARELTO®

WHAT SHOULD I TELL MY DOCTOR BEFORE OR WHILE TAKING XARELTO®?

Before taking XARELTO® tell your doctor if you:

  • Have ever had bleeding problems
  • Have liver or kidney problems
  • Have any other medical condition
  • Are pregnant or planning to become pregnant
  • Are breastfeeding or plan to breastfeed

Tell all of your doctors and dentists that you are taking XARELTO®. They should talk to the doctor who prescribed XARELTO® for you before you have any surgery, medical or dental procedure.

Tell your doctor about all the medicines you take, including pre
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SOURCE Janssen Research & Development, LLC
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