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The U.S. Food and Drug Administration (FDA) recently approved the drug raloxifene (brand name, Evista) to reduce the risk of invasive breast cancer in post-menopausal women with osteoporosis and in post-menopausal women at high risk for invasive breast cancer. Before the approval, tamoxifen was the only drug FDA-approved to prevent breast cancer in high-risk women. The FDA's approval of raloxifene provides eligible women with another option to help guard against breast cancer. Raloxifene was first approved by the FDA in December 1997 to prevent osteoporosis, a bone-thinning disease that can put women and men at risk of bone fractures. Researchers have been investigating raloxifene's potential benefits in several clinical trials over the past decade, including the STAR (Study of Tamoxifen and Raloxifene) trial. The FDA's approval of raloxifene to reduce the risk of invasive breast cancer in post-menopausal women with osteoporosis and in post-menopausal women at high risk for invasive breast cancer comes after the results of three recent studies (RUTH, MORE and CORE). Together, the studies involved 15,234 post-menopausal women and compared the effectiveness of raloxifene to a placebo, or inactive pill. The results showed that raloxifene reduced the risk of invasive breast cancer by 44 to 71 percent. In addition, initial results of the STAR trial of over 19,000 women found that the observed incidence rates of invasive breast cancer were 4.4 per 1,000 per year for those taking raloxifene and 4.3 per 1,000 per year for those taking tamoxifen. "Today's action provides an important new option for women at heightened risk of breast cancer," said Steven Galson, M.D., M.P.H., director, FDA's Center for Drug Evaluation and Research, in an FDA news release. However, the FDA also cautions that dangers exist with raloxifene. "Because [raloxifene] can cause serious side effects, the benefits and risks of taking [raloxifene] should be carefully evaluated for each individual woman. Women should talk with their health care provider about whether the drug is right for them," said Dr. Galson, in an FDA news release. According to the FDA, raloxifene can cause serious side effects including blood clots in the legs and lungs, and death due to stroke. Women with current or prior blood clots in the legs, lungs, or eyes should not take Evista. Other potential side effects include:
The FDA cautions that raloxifene should not be taken by pre-menopausal women and women who are or may become pregnant because it may cause harm to the unborn baby. In addition, ralxofene should not be taken with cholestyramine (a drug used to lower cholesterol levels) or estrogens. The FDA also warned that raloxifene does not provide complete prevention against breast cancer. Women should continue to get annual mammograms and clinical breast exams. Women at high-risk of developing breast cancer include those with a strong family history of the disease, genetic risk factors of breast cancer, or a history of pre-breast cancerous conditions. A physician should determine whether a woman is at high risk of breast cancer.
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