Raloxifene precautions

List of precautions
Pregnancy Lactation Children Hepatic function Breast abnormality Concurrent estrogen therapy Endometrium History of breast cancer Lipid metabolism Premenopausal use Use in men Death due to stroke Cardiovascular disease History of hypertriglyceridemia when treated with estrogens Renal impairment Venous thromboembolic events

Pregnancy
Category X. Return to top

Lactation
Undetermined. Return to top

Children
Safety and efficacy not established. Return to top

Hepatic function
Safety and efficacy not evaluated in patients with severe hepatic function impairment. Return to top

Breast abnormality
Any unexplained breast abnormality occurring during Raloxifene therapy should be investigated. Raloxifene does not eliminate the risk of breast cancer. Return to top

Concurrent estrogen therapy
Concurrent use with systemic estrogens is not recommended. Return to top

Endometrium
Because raloxifene does not affect endometrial proliferation unexplained uterine bleeding should be investigated as clinically indicated. Return to top

History of breast cancer
Raloxifene has not been adequately studied in women with history of breast cancer. Return to top

Lipid metabolism
Raloxifene lowers serum total and LDL cholesterol but does not affect total HDL or triglycerides. Return to top

Premenopausal use
Safety and efficacy not established. Use is not recommended. Return to top

Use in men
Safety and efficacy not established. Return to top

Death due to stroke
In a clinical trial of postmenopausal women with documented coronary heart disease or at increased risk for coronary events, an increased risk of death due to stroke was observed after treatment with Raloxifene. During an average follow-up of 5.6 years, 59 (1.2%) Raloxifene-treated women died due to a stroke compared to 39 (0.8%) placebo-treated women (22 versus 15 per 10,000 women-years; hazard ratio 1.49; 95% confidence interval, 1.00-2.24; p=0.0499). There was no statistically significant difference between treatment groups in the incidence of stroke (249 in Raloxifene [4.9%] versus 224 placebo [4.4%]). Raloxifene had no significant effect on all-cause mortality. The risk-benefit balance should be considered in women at risk for stroke, such as prior stroke or transient ischemic attack (TIA), atrial fibrillation, hypertension, or cigarette smoking. Return to top

Cardiovascular disease
Raloxifene should not be used for the primary or secondary prevention of cardiovascular disease. In a clinical trial of postmenopausal women with documented coronary heart disease or at increased risk for coronary events, no cardiovascular benefit was demonstrated after treatment with raloxifene for 5 years. Return to top

History of hypertriglyceridemia when treated with estrogens
Limited clinical data suggest that some women with a history of marked hypertriglyceridemia (>5.6 mmol/L or >500 mg/dL) in response to treatment with oral estrogen or estrogen plus progestin may develop increased levels of triglycerides when treated with Raloxifene. Women with this medical history should have serum triglycerides monitored when taking Raloxifene. Return to top

Renal impairment
Raloxifene should be used with caution in patients with moderate or severe renal impairment. Safety and efficacy have not been established in patients with moderate or severe renal impairment. Return to top

Venous thromboembolic events
Raloxifene is associated with an increased risk of thromboembolic events. The greatest risk for deep vein thrombosis and pulmonary embolism occurs during the first 4 months of treatment, and the magnitude of risk appears to be similar to the reported risk associated with use of hormone therapy. Because immobilization increases the risk for venous thromboembolic events independent of therapy, Raloxifene should be discontinued at least 72 hours prior to and during prolonged immobilization (e.g., post-surgical recovery, prolonged bed rest), and Raloxifene therapy should be resumed only after the patient is fully ambulatory. In addition, women taking Raloxifene should be advised to move about periodically during prolonged travel. The risk-benefit balance should be considered in women at risk of thromboembolic disease for other reasons, such as congestive heart failure, superficial thrombophlebitis, and active malignancy Return to top