Raloxifene for osteoporosis side effects, cancer prevention?
February 10 2016 by
Ray Sahelian, M.D.


Raloxifene is used to prevent and treat bone loss (osteoporosis) in women after menopause. Raloxifene is different from estrogens and progesterone. It works by acting like estrogen (as a selective estrogen receptor modulator or SERM) in some parts of the body. Raloxifene (Evista) has been proposed to be a better choice than tamoxifen (Nolvadex, and others) for prevention of breast cancer in high-risk postmenopausal women. However, new research indicates that the cardiovascular side effects of raloxifene may outweigh its potential benefits in breast cancer prevention. For natural ways to prevent or treat osteoporosis without the use of Raloxifene or other potentially harmful SERMs, see osteoporosis.


The USPSTF recommends that clinicians engage in shared, informed decision making with women who are at increased risk for breast cancer about medications to reduce their risk. For women who are at increased risk for breast cancer and at low risk for adverse medication effects, clinicians should offer to prescribe risk-reducing medications, such as tamoxifen or raloxifene. (B recommendation) The USPSTF recommends against the routine use of medications, such as tamoxifen or raloxifene, for risk reduction of primary breast cancer in women who are not at increased risk for breast cancer.


Maturitas. 2013 August. Effects of raloxifene on cognition, mental health, sleep and sexual function in menopausal women: a systematic review of randomized controlled trials. Raloxifene may have some benefit for cognition, but it is not significant effect on anxiety, depression, sleep, sexual function, vasomotor symptoms and worsens menstrual symptoms. This drug is safe for treating osteoporosis and preventing breast cancer in menopausal women, but it is not suitable for patients who have any arterial stenosis or thrombophilia.


Raloxifene for breast cancer prevention?

Women with heart disease or a high risk for it would trade one set of odds for another if they took the drug raloxifene to try to prevent breast cancer. Reloxifene helps prevent cancer, but raise the risk of blood clots and fatal strokes. Raloxifene also doesn't lower the risk of death, hospitalization or heart attack. Doctors have been testing raloxifene as an alternative to tamoxifen for preventing breast cancer and as a way to lower heart disease risks.The results of the study, which involved 10,101 postmenopausal women in the United States and 25 other countries were published in the July, 2006 issue of the New England Journal of Medicine. Many of the authors consult or work for Indianapolis-based Eli Lilly & Co., which makes raloxifene and paid for the study. The drug is sold as Evista for treating the bone disease osteoporosis, but the company is seeking approval to market it for breast cancer prevention. A similar drug, tamoxifen, has long been used to prevent breast cancers whose growth is fueled by the hormone estrogen. A big federal study reported in June, 2006 that raloxifene was equally effective at preventing the most serious types of breast cancer and with fewer side effects, although some doctors disagree on how large the differences in side effects really are. That study, called STAR, directly compared the two drugs in women at higher-than-usual risk of developing breast cancer. The new study involved a different group of women -- those at high risk of heart problems -- and tested whether raloxifene was better than dummy pills at reducing breast cancer and heart-related risks. Participants either had clogged arteries or multiple heart risk factors, such as advanced age, diabetes, smoking, high blood pressure or high cholesterol. About 40 percent also had elevated risk of breast cancer, mostly because of their age, but this was not the main reason they were in this study -- their heart risk was. Roughly half were given daily raloxifene pills and the others, dummy pills. After an average of five years on the pills, deaths and major heart problems were about the same in both groups. Raloxifene users had one-third fewer cases of breast cancer and about half the number of invasive breast cancers -- benefits seen previously. It appears that the moderate breast cancer prevention benefits do not seem to justify the risks of raloxifene for women already prone to heart problems.


Raloxifene side effects, danger, caution, toxicity
Raloxifene side effects may be divided into three sections. Common raloxifene side effects include bloody or cloudy urine, chest pain; difficult, burning, or painful urination, fever, frequent urge to urinate, infection, including body aches or pain, congestion in throat, cough, dryness or soreness of throat, and loss of voice, runny nose, leg cramping, skin rash, swelling of hands, ankles, or feet, vaginal itching. Less common raloxifene side effects include abdominal pain, aching body pains, congestion in lungs and shortness of breadth, decreased vision or other changes in vision, diarrhea, difficulty in breathing, hoarseness, loss of appetite, nausea, trouble in swallowing, and weakness. Rare raloxifene side effects may include coughing blood; headache or migraine headache; loss of or change in speech, coordination, or vision, pain or numbness in chest, arm, or leg. Treatment with the nonsteroidal selective estrogen receptor modulator raloxifene may increase the risk of venous blood clot events and stroke deaths in postmenopausal women.


Raloxifene and stroke risk
In postmenopausal women at increased risk for coronary events, the incidences of venous blood clots and fatal strokeare higher in those assigned raloxifene versus placebo. Treatment decisions about raloxifene should be based on a balance of projected absolute risks, side effects, and benefits.

Raloxifene Research

Patient-reported symptoms and quality of life during treatment with tamoxifen or raloxifene for breast cancer prevention: the NSABP Study of Tamoxifen and Raloxifene (STAR) P-2 trial.
JAMA. 2006. Land SR, Wickerham DL, Costantino JP, Ritter MW, Vogel VG, Pajon ER, Wade JL 3rd, Dakhil S, Lockhart JB Jr, Wolmark N, Ganz PA. National Surgical Adjuvant Breast and Bowel Project (NSABP) Operations and Biostatistical Centers, Department of Biostatistics, Graduate School of Public Health, University of Pittsburgh, Pittsburgh, Pa
Tamoxifen has been approved for breast cancer risk reduction in high-risk women, but how raloxifene compares with tamoxifen is unknown. To compare the differences in patient-reported outcomes, quality of life [QOL], and symptoms in Study of Tamoxifen and Raloxifene (STAR) participants by treatment assignment. No significant differences existed between the tamoxifen and raloxifene groups in patient-reported outcomes for physical health, mental health, and depression, although the tamoxifen group reported better sexual function. Although mean symptom severity was low among these postmenopausal women, those in the tamoxifen group reported more gynecological problems, vasomotor symptoms, leg cramps, and bladder control problems, whereas women in the raloxifene group reported more musculoskeletal problems, dyspareunia, and weight gain.


Q. Are there natural supplements that could potentially be helpful for breast cancer? My doctor wants me to take raloxifene but I'm worried about the heart side effects.

   A. Although research is quite early, there are many supplements that have been found in test tube studies to have potential benefit for breast cancer. See these links curcumin is extracted from the spice turmeric, and the fruit
Mangosteen. If you click on the link breast cancer at the top of the page, you will see additional options that you can discuss with your doctor.