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Selective estrogen receptor modulators (SERMs)
Raloxifene (Evista)
Raloxifene (Evista) belongs to a class of drugs called selective estrogen receptor modulators (SERMs). SERMs work like estrogen in some tissues but as an anti-estrogen in other tissues. The SERMs are developed to reap the benefits of estrogen while avoiding the potential side effects of estrogen. Thus, raloxifene can act like estrogen on bone, but as an anti-estrogen on the lining of the uterus.
The first SERM to reach the market was tamoxifen, which blocks the stimulative effect of estrogen on breast tissue. Tamoxifen has proven valuable in women who have had cancer in one breast in preventing cancer in the second breast. Raloxifene is the second SERM to be approved by the FDA. Raloxifene has been approved for the prevention and treatment of osteoporosis in postmenopausal women. In a three year study involving some 600 postmenopausal women, raloxifene was found to increase bone density and lower LDL cholesterol, while having no stimulative effect on the uterine lining (which means that it is unlikely to cause uterine cancer).
Because of its anti-estrogen effects, the most common side effects with raloxifene are hot flashes. Conversely, because of its estrogenic effects, raloxifene increases the risk of blood clots, including deep vein thrombosis (DVT) and pulmonary embolism (blood clots in the lung). The greatest increase in risk occurs during the first 4 months of use. Patients taking raloxifene should avoid prolonged periods of immobility during travel, when blood clots are more prone to occur. The risk of deep vein thrombosis with raloxifene is probably comparable to that of estrogen, about 2 to 3 times higher than the usual low occurrence rate. Raloxifene decreases the risk of spine fractures in postmenopausal women with osteoporosis, but the benefit in decreasing hip fracture risk is not yet known. (The only agents that are definitely proven to decrease hip fracture risk are bisphosphonates.) For more, please read the Evista drug information article.
VIVELLE-DOT (estradiol transdermal system) IS AVAILABLE BY PRESCRPTION ONLY.
INDICATION
Vivelle-Dot is used after menopause to: reduce moderate to severe hot flashes; treat moderate to severe dryness, itching and burning in or around the vagina; help reduce your chances of getting osteoporosis (thin weak bones); and treat certain conditions in which a young woman's ovaries do not produce enough estrogens naturally. Vivelle-Dot 0.025 mg/day is only used to prevent osteoporosis from menopause. If you use Vivelle-Dot only to treat your dryness, itching, and burning in and around your vagina or if you use Vivelle-Dot only to prevent osteoporosis from menopause, talk with your healthcare professional about whether a different treatment or medicine without estrogens might be better for you.
IMPORTANT SAFETY INFORMATION
Estrogens increase the chances of getting cancer of the uterus (womb). Report any unusual vaginal bleeding right away while you are taking estrogens. Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb).
Do not use estrogens with or without progestins to prevent heart disease, heart attacks, or strokes. Using estrogens with or without progestins may increase your chances of getting heart attacks, strokes, breast cancer, and blood clots. Using estrogens with progestins may increase your risk of dementia (decline in memory and thinking skills).
Vivelle-Dot should not be used if you have unusual vaginal bleeding; currently have or have had certain cancers, including cancer of the breast or uterus; had a stroke or heart attack in the recent past (for example, in the past year); currently have or have had blood clots; currently have or have had liver problems; or think you may be, or know that you are, pregnant.
The most common side effects that may occur with Vivelle-Dot are headache, breast tenderness, and back pain.
You and your healthcare professional should talk regularly about whether you still need treatment with Vivelle-Dot.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Please see Full Prescribing Information for Vivelle-Dot.
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