The label now includes a black box warning that it can increase the risk of death, MI, stroke, venous thromboembolism, thrombosis of vascular access, and tumor progression or recurrence.
Rivaroxaban is currently indicated in the US for stroke reduction in patients with atrial fibrillation, for the treatment and prevention of recurrence of deep venous thrombosis and pulmonary embolism, and for DVT prophylaxis after orthopedic surgery.