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Xarelto Linked to Serious Internal Bleeding and Blood Clots

Feb 13, 2016

Xarelto (rivaroxaban), one of a newer class of blood thinners, has been linked to serious internal bleeding and blood clots.

Blood thinners are prescribed for patients suffering from atrial fibrillation (arrhythmia of the heart) and to prevent blood clots, deep vein thrombosis (DVT) and pulmonary embolism in patients who are undergoing knee or hip replacement surgery. Deep vein thrombosis occurs when a blood clot forms in the veins deep in the leg. If a part of the clot breaks off, it can be swept into the bloodstream and become lodged in the lungs. This is known as a pulmonary embolism and may be a life-threatening condition.

Older blood thinners like warfarin (Coumadin) have carefully established prescribing protocols that allow doctors to monitor patients bleeding risks and deal with adverse side effects when they are taking the drug. Xarelto is an alternative to warfarin, an anticoagulant that has been on the market for more than 60 years.

Xarelto and the drugs in its class are marketed as being more convenient than warfarin because these drugs do not have the blood-testing requirements or dietary restrictions imposed on warfarin users. But though there is an antidote to internal bleeding linked to warfarin, there is no known antidote to Xarelto bleeding, and this makes Xarelto bleeding events potentially more dangerous for those taking Xarelto.

Patients taking Xarelto (rivaroxaban), Eliquis (apixaban), Pradaxa (dabigatran) or Lixiana (edoxaban) should be alert to the risk of:

  • internal bleeding
  • pulmonary embolism
  • heart attack
  • stroke
  • brain hemorrhage

An individual taking Xarelto should consult a doctor if he or she experiences:

  • frequent nose bleeds
  • unusual bleeding from the gums
  • menstrual bleeding that is heavier than normal
  • vaginal bleeding
  • bleeding that is severe or cannot be controlled
  • red, pink or brown urine
  • bright red or black stools (looks like tar)
  • coughing up blood or blood clots
  • vomiting blood or vomit looks like “coffee grounds”
  • headaches
  • dizziness or weakness
  • pain, swelling, or new drainage at wound sites

The FDA warns that individuals may have a higher risk of bleeding if taking Xarelto as well as other medicines that increase the risk of bleeding. Such medications include:

  • aspirin or aspirin containing products
  • non-steroidal anti-inflammatory drugs (NSAIDs)
  • warfarin sodium (Coumadin, Jantoven)
  • any medicine that contains heparin
  • clopidogrel (Plavix)
  • other medicines to prevent or treat blood clots

The agency recommends that patients consult a doctor or pharmacist if they are unsure whether a medicine they are taking falls in one of these categories.

A number of patients who have experienced serious Xarelto bleeding events have filed lawsuits against Janssen Pharmaceuticals, the manufacturer of Xarelto. In December 2014, the United States Judicial Panel on Multidistrict Litigation centralized 21 Xarelto legal actions, transferring them to the Eastern District of Louisiana, before Judge Eldon E. Fallon, for coordinated or consolidated pretrial proceedings. During 2015, Judge Fallon issued a number of pretrial orders, including two orders requiring the parties to the suits to preserve emails, text messages and instant messages relating to the litigation.

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