Why is this medication prescribed?

Raloxifene is used to prevent and treat osteoporosis, a disease common in women past menopause, which results in bones that break easily. Raloxifene is in a class of medications called selective estrogen receptor modulators (SERMs). It works by acting similar to estrogen, a female hormone produced by the body. Like estrogen, raloxifene increases the density of bone.

How should this medicine be used?

Raloxifene comes as a tablet to take by mouth. It is usually taken once a day at any time, with or without food. To help you remember to take raloxifene, take it around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take raloxifene exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Continue to take raloxifene even if you feel well. Do not stop taking raloxifene without talking to your doctor.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

Other uses for this medicine

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information. There is interest in possible beneficial effects of raloxifene on breast cancer risk in women.

What storage conditions are needed for this medicine?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

In case of emergency/overdose

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

What other information should I know?

Keep all appointments with your doctor and the laboratory. You should have a complete physical examination, including blood pressure measurements, breast and pelvic exams, and a Pap test at least yearly. Follow your doctor's directions for examining your breasts; report any lumps immediately. Your doctor may order certain lab tests to check your body's response to raloxifene.

Before you have any laboratory tests, tell the person doing the test that you take raloxifene, as this medication may interfere with some lab tests.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

Raloxifene Lowers Risk of Invasive Breast Cancer for Some Women 

The US Food and Drug Administration (FDA) has approved raloxifene (Evista) for breast cancer risk reduction in two groups of postmenopausal women: those with the bone-thinning condition osteoporosis and those at high risk for invasive breast cancer. It joins tamoxifen as just the second so-called chemoprevention drug to be approved for breast cancer. 

Under the brand name Evista, raloxifene is already approved, and widely prescribed, for the prevention and treatment of osteoporosis in postmenopausal women. Researchers had previously observed that these women -- roughly half a million at present -- had lower rates of breast cancer than the general population. 

Raloxifene is a type of drug known as a selective estrogen receptor modulator, or SERM. In reducing the risk of invasive breast cancer, SERMs may act by blocking estrogen receptors in the breast.   The expanded use of raloxifene -- based on positive clinical studies of approximately 37,000 postmenopausal women over a 10-year period -- "provides an important new option for women at heightened risk of breast cancer," said Dr. Steven Galson, director of the FDA's Center for Drug Evaluation and Research. 

In its announcement, the FDA noted that raloxifene can cause serious side effects, including blood clots in the legs and death due to stroke. Other potential side effects include hot flashes, leg cramps, swelling of the legs and feet, flu-like symptoms, joint pain, and sweating. 

The FDA said women with current or prior blood clots in the legs, lungs, or eyes should not take raloxifene. It should not be taken with cholestyramine, a drug used to lower cholesterol levels, or with estrogens.  It also should not be taken by women who are or may become pregnant. At present, tamoxifen remains the drug of choice for women who have not gone through menopause and have a high breast cancer risk. Raloxifene's breast cancer risk reduction effects have not been studied in younger women. 

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