Increased Risk of Venous Thromboembolism and Death from Stroke

• Increased risk of deep vein thrombosis and pulmonary embolism have been reported with this drug.
• Women with active or past history of venous thromboembolism should not take this drug.
• 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.