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U.S. Department of Health and Human Services

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Evista Approved for Reducing Breast Cancer Risk

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FDA has approved Evista (raloxifene hydrochloride) for reducing the risk of invasive breast cancer in postmenopausal women with osteoporosis and in postmenopausal women at high risk for invasive breast cancer. Invasive breast cancer develops when abnormal cells spread into the surrounding breast tissue.

Evista, which is manufactured by Eli Lilly and Company, Indianapolis, Ind., is only the second drug approved to reduce the risk of breast cancer. The drug was already approved for preventing and treating osteoporosis in postmenopausal women.

Effectiveness

Evista is commonly referred to as a selective estrogen receptor modulator (SERM). In reducing the risk of invasive breast cancer, SERMs may act by blocking estrogen receptors in the breast.

Three clinical trials in 15,234 postmenopausal women comparing Evista to placebo (no drug) demonstrated that Evista reduces the risk of invasive breast cancer by 44 to 71 percent. A fourth clinical trial in 19,747 postmenopausal women at high risk for developing breast cancer compared Evista to tamoxifen. In this trial, the risk of developing invasive breast cancer was similar for the two treatments.

Evista does not completely prevent breast cancer. Breast examinations and mammograms should be done before starting Evista and regularly thereafter.

Evaluating Benefits and Risks

Because Evista can cause serious side effects, the benefits and risks of taking the drug should be carefully evaluated for each woman. Women should talk with their health care providers about whether the drug is right for them.

    • Evista 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 hot flashes, leg cramps, swelling of the legs and feet, flu-like symptoms, joint pain, and sweating.
    • Evista should not be taken by premenopausal women and women who are or may become pregnant, because it may cause harm to the unborn baby.
    • Evista should not be taken with cholestyramine (a drug used to lower cholesterol levels) or estrogens.

This article appears on FDA's Consumer Update page, which features the latest on all FDA-regulated products.

Date Posted: Sept. 17, 2007