What is Xarelto?


Xarelto is the brand name of an oral blood-thinning drug with the generic name rivaroxaban. It is part of a new generation of anti-coagulant drugs intended to prevent deep vein thrombosis (DVT). DVT is a potentially fatal condition characterized by the formation of blood clots in veins, primarily in the legs, often after surgery like a hip or knee replacement or after an injury. DVT can be fatal if venous blood clots dislodge and travel to the lungs, creating a potentially lethal condition called pulmonary embolism (PE).


In July 2011, the U.S. Food and Drug Administration (FDA) approved the use of Xarelto for the prevention of DVT in patients receiving hip or knee replacements.

In November 2011, the FDA additionally approved Xarelto for the prevention of strokes in patients with non-valvular atrial fibrillation, a type of heart arrhythmia in patients who don’t have disease of the aortic or mitral valve. Strokes occur with the presence of blood clots on the brain.

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Xarelto Facts

Xarelto, along with other anti-coagulants including dabigatran and apixaban, were developed with the intention of replacing warfarin (brand name Coumadin), a blood-thinning medication that was originally used as a pesticide against rodents but has been used to prevent blood clotting since the 1950s. Warfarin, however, interacts with many other drugs and even foods, and requires frequent blood monitoring. The new generation of blood thinners was considered to be safer and more convenient than warfarin. Xarelto is an oral tablet of 15 mg or 20 mg administered once daily.

The New England Journal of Medicine reported results of the ROCKET AF study in 2011. The study included over 14,000 patients and showed that Xarelto did no better than warfarin in preventing AF but Xarelto caused more abdominal bleeding than warfarin. Additionally, Xarelto is much more expensive, costing about $3000 per patient per year compared to about $200 for warfarin.

Who Manufactures Xarelto?

Xarelto is produced by Bayer A.G., a German pharmaceutical company best known for the development of aspirin. Xarelto is marketed by Janssen Pharmaceuticals, a New Jersey-based division of Johnson & Johnson, maker of a host of well-known household and medical products. Bayer considers Xarelto to be its main revenue source, earning the company over $170 million in the first quarter of 2015 alone.

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Severe Side Effects

Uncontrolled bleeding is a risk with any anti-coagulant medication. However, with Xarelto there is no way to stop bleeding even if it’s from a relatively minor injury.

Vitamin K is a nutrient found in many foods (especially leafy greens) that enables blood clotting. Warfarin works by disabling the action of Vitamin K, therefore if major bleeding occurs while taking warfarin, emergency administration of a lot of Vitamin K can act as an antidote. Xarelto, on the other hand, works by preventing the body’s production of Vitamin K altogether. If an uncontrolled bleed happens while taking Xarelto, there is no antidote. This has lead to deaths in emergency room settings.

  • Bleeding gums
  • Bloody stools
  • Coughing up blood
  • Nosebleeds
  • Back pain
  • Bowel or bladder dysfunction
  • Paralysis
  • Numbness or tingling
  • Dizziness or headache
  • Difficulty breathing or swallowing
  • Leg weakness
  • Red or Dark Brown Urine

Xarelto Lawsuits

Over 400 lawsuits have been filed against Bayer and Janssen accusing them of misleading patients about the safety of Xarelto. These suits allege that Bayer and Janssen hid the risk of uncontrolled internal bleeding without the option for an emergency antidote. Also, they accuse the manufacturers of continuing to sell the drug even with knowledge that it can cause irreversible bleeding.

On January 22, 2015, an administrative judge ruled that 75 lawsuits in Pennsylvania would be combined in a mass tort suit in Philadelphia. There is currently a Multi-District Litigation (MDL #2582) overseen by Judge Elton Fallon. As of April 2015 there have been over 400 federal lawsuits filed. Patients are suing to be compensated for medical expenses, injury and other losses. The families of patients who died from their complications are also suing for damages on behalf of their loved ones.

If you or someone you know has experienced severe bleeding associated with taking Xarelto, you may have a legal case.