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FDA's Black Box Warning For Xarelto
In 2014 the FDA required manufacturers of Xarelto to change the warning, precautions, and black box label. The label changes warns patients and caregivers of the risks and dangerous side effects of Xarelto.
- Risk of bleeding. “Promptly evaluate any signs or symptoms of blood loss and consider the need for blood replacement.
- A specific antidote is not available
- Avoid concomitant use with P-gp and Strong CYP3A4 Inhibitors or Inducers
- Not recommended “in patients with pulmonary embolism who present with hemodynamic instability or who may receive thrombolysis or pulmonary embolectomy.”
- Risk of bleeding with epidural or spinal anesthesia or spinal puncture.
- “Monitor frequently to detect any signs or symptoms of neurological impairment.”
Xarelto FDA Approval Timeline
The FDA had initially approved Xarelto for DVT (deep vein thrombosis) treatment or pulmonary embolism following hip or knee replacement. The FDA has since has also approved Xarelto for atrial fibrillation treatment to reduce the risk of stroke, and for treating existing DVT (deep vein thrombosis) or pulmonary embolism.
Jul 2011: Xarelto received FDA approval for reducing the risk of deep vein thrombosis and pulmonary embolism after hip and knee surgery
Nov 2011: Approved for reducing the risk of stroke in people with nonvalvular atrial fibrillation
Nov 2012: Approved for treating deep vein thrombosis or pulmonary embolism and reducing the risk of recurrence after initial treatment