FDA Warnings

Xarelto received FDA approval in 2011 to reduce the risk of blood clots, deep vein thrombosis, and pulmonary embolism following knee or hip replacement surgery. However, Due to the dangerous nature of Xarelto increasing the risk of uncontrollable bleeding, the FDA required makers of Xarelto to place a "black box" warning on their product. A black box warning indicates the FDA's most urgent strongest warning for the risks associated with using the product. These warnings include:
  • Xarelto can cause serious and fatal bleeding
  • May cause pregnancy-related hemorrhage
  • Increased risk of thrombotic events after premature discontinuation
  • Increased GI bleeding in patients with artificial heart valves
  • Spinal/Epidural hematoma may occur with spinal puncture or neuraxial anesthesia
  • May cause renal failure in patients with renal impairment
  • May cause liver failure in patients with hepatic impairment