Evista OK for Breast Cancer Prevention
FDA Approves Osteoporosis Drug Evista for Breast Cancer Prevention in Certain Postmenopausal Women
Sept. 14, 2007 -- The FDA today approved the osteoporosis drug Evista to reduce breast cancer risk in some postmenopausal women.
Specifically, the FDA approved Evista to lower the risk of invasive breast cancer (the most common form of breast cancer) in two groups of women:
- Postmenopausal women with osteoporosis
- Postmenopausal women at high risk for invasive breast cancer
Evista is only the second drug approved to reduce breast cancer risk (tamoxifen was the first).
In the U.S., breast cancer is the No. 2 cause of women's cancer deaths (lung cancer is first). Breast cancer accounts for 26% of all cancers among U.S. women.
"Today's action provides an important new option for women at heightened risk of breast cancer," says Steven Galson, MD, MPH, in an FDA news release.
But Galson -- who directs the FDA's Center for Drug Evaluation and Research -- cautions that Evista may not be right for all postmenopausal women.
Weigh Risks, Benefits
"Because Evista can cause serious side effects, the benefits and risks of taking Evista should be carefully evaluated for each individual woman. Women should talk with their health care provider about whether the drug is right for them," says Galson.
The FDA notes that Evista can cause serious side effects including blood clots in the legs and lungs and death due to stroke. Women with current or previous blood clots in the legs, lungs, or eyes shouldn't take Evista.
Other potential side effects include hot flashes, leg cramps, swelling of the legs and feet, flu-like symptoms, joint pain, and sweating, according to the FDA.
Evista shouldn't be taken by premenopausal women and women who are pregnant or may become pregnant because the drug may harm the fetus. Evista also shouldn't be taken with cholestyramine (a drug used to lower cholesterol levels) or estrogens.
Evista doesn't completely prevent breast cancer. Breast examinations and mammograms should be done before starting Evista and regularly thereafter.
Evista belongs to a class of drugs of called selective estrogen receptor modulators (SERMs).
SERMS may reduce the risk of invasive breast cancer by blocking estrogen receptors in the breast, according to the FDA. Most, but not all, breast cancers are sensitive to estrogen.