Raloxifene Interactions

FDA Black Box Warning

WARNING: INCREASED RISK OF VENOUS THROMBOEMBOLISM AND DEATH FROM STROKE WARNING: INCREASED RISK OF VENOUS THROMBOEMBOLISM AND DEATH FROM STROKE Increased risk of deep vein thrombosis and pulmonary embolism have been reported with raloxifene hydrochloride tablets [see Warnings and Precautions ( 5.1 )]. Women with active or past history of venous thromboembolism should not take raloxifene hydrochloride tablets [see Contraindications ( 4.1 )]. 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 [see Warnings and Precautions ( 5.2 ) and Clinical Studies ( 14.5 )]. WARNING: INCREASED RISK OF VENOUS THROMBOEMBOLISM AND DEATH FROM STROKE See full prescribing information for complete boxed warning. Increased risk of deep vein thrombosis and pulmonary embolism have been reported with raloxifene hydrochloride tablets ( 5.1 ). Women with active or past history of venous thromboembolism should not take raloxifene hydrochloride tablets ( 4.1 ). 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 ( 5.2 , 14.5 ).