The study found no increased risk of cancer, deep vein thrombosis or stroke.

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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.

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As with combination therapy, the risk of fractures is lower, but there is an increased risk of stroke, gallbladder disease, deep vein thrombosis and urinary incontinence.

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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.

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