Raloxifene (Evista) Risks, Warnings, and Complications

VENOUS THROMBOEMBOLISM: During clinical trials, women on raloxifene were found to have a higher risk of venous thromboembolism, including deep vein thrombosis and pulmonary embolism (blood clots in the legs and lungs, respectively), as well as other venous thromboembolic events. There are also reports of less serious problems like superficial thrombophlebitis in patients taking raloxifene compared to placebo (an inactive substance). 

The risk of blood clots is highest in the first 4 months of raloxifene treatment. The risk is similar to that associated with hormone replacement therapy. 

Prolonged immobility can increase the risk of developing a blood clot. Your doctor will therefore recommend discontinuing raloxifene at least 72 hours before and during prolonged immobilization, such as in the postoperative period or if you have conditions requiring prolonged bed rest. You will be able to resume treatment with raloxifene once you are fully ambulatory again. 

To lower your risk of blood clots, move regularly during prolonged travel (take breaks during long car rides and get up and move around on long airplane flights). 

If you have other risk factors for thromboembolic disease (blood clots), such as congestive heart failure, superficial thrombophlebitis, or an active malignancy (cancer), your doctor will carefully weigh the benefits versus risks of raloxifene therapy before prescribing this drug to you.

INCREASED RISK OF DEATH FROM STROKE: Clinical trials have found that in postmenopausal women with coronary artery disease or an increased risk for coronary events, there is an increased risk of death from stroke while on raloxifene. There is no increased incidence of stroke noted, however. Your healthcare provider will evaluate the risk vs benefit of raloxifene based on your risk factors for stroke. Stroke risk factors include transient ischemic attacks (TIAs or mini-strokes), prior strokes, hypertension (high blood pressure), atrial fibrillation (a type of irregular heartbeat), and smoking. 

PREVENTION OF CARDIOVASCULAR DISEASE: Raloxifene should not be used to prevent cardiovascular disease. During clinical trials in postmenopausal women with coronary heart disease or an increased risk of coronary events, there was no evidence that raloxifene decreases cardiovascular risk after 5 years of treatment. 

USE IN PREMENOPAUSAL WOMEN: The safety of raloxifene has not been established in premenopausal women. There are no indications or beneficial effects of this medicine in women who are still getting monthly menstrual periods. 

KIDNEY AND LIVER DISEASE: Raloxifene should be used with caution in people with decreased liver function or decreased kidney function. The safety and efficacy of this drug have not been established in people with hepatic impairment or moderate to severe renal impairment.

USE WITH ESTROGEN THERAPY: Raloxifene safety with systemic estrogens has not been established and is not recommended.

HYPERTRIGLYCERIDEMIA WITH ESTROGENS: There is some evidence that women who developed marked hypertriglyceridemia (high triglyceride levels) after treatment with oral estrogen-only or estrogen plus progestin could have similar effects while on raloxifene. Your doctor will monitor serum triglyceride levels during treatment with raloxifene. 

WOMEN WITH A HISTORY OF BREAST CANCER: Raloxifene has not been studied in women who have had breast cancer previously. 

USE IN MEN: There is no indication for raloxifene in men and its use is not recommended. The safety and efficacy of this drug have not been adequately studied in men.

UNEXPLAINED VAGINAL BLEEDING: Clinical studies have shown that raloxifene-treated and placebo-treated patients have similar rates of endometrial proliferation (thickening of the lining of the uterus). Seek a medical evaluation for any unexplained uterine bleeding while on raloxifene. 

BREAST ABNORMALITIES: Raloxifene reduces the risk of invasive breast cancer in postmenopausal women but does not eliminate the risk. Seek medical evaluation for any breast changes during treatment.