FDA Black Box Warning
WARNING: INCREASED RISK OF VENOUS THROMBOEMBOLISM AND DEATH FROM STROKE
- Increased risk of deep vein thrombosis and pulmonary embolism have been reported with Evista. Women with active or past history of venous thromboembolism should not take Evista.
- Increased risk of death due to stroke occurred in a trial in postmenopausal women with documented coronary heart disease or at increased risk for major coronary events. Consider risk-benefit balance in women at risk for stroke.