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News Center
Osteoporosis drug Evista approved to cut risk of breast cancer
The U.S. Food and Drug Administration approved Evista on Friday for reducing the risk of invasive breast cancer in postmenopausal women with osteoporosis and in postmenopausal women at high risk for invasive breast cancer.
In 1997, FDA approved Evista, which is manufactured by Eli Lilly and Company, for the prevention of osteoporosis in postmenopausal women and, in 1999, for the treatment of postmenopausal women with osteoporosis.
Previously as a drug for osteoporosis, Evista is now only the second drug approved to reduce the risk of breast cancer. 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.
"Today's action provides an important new option for women at heightened risk of breast cancer," said Steven Galson, director of FDA's Center for Drug Evaluation and Research. "Because Evista can cause serious side effects, the benefits and risks of taking Evista should be carefully evaluated for each individual woman."
The serious side effects include 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 unbornbaby, warned FDA in its statement.
In addition, Evista should not be taken with cholestyramine (a drug used to lower cholesterol levels) or estrogens.
Evista does not completely prevent breast cancer. Breast examinations and mammograms should be done before starting Evista and regularly thereafter, said FDA.
Breast cancer is the second leading cause of cancer death in American women and accounts for 26 percent of all cancers among women. An estimated 178,480 new cases of invasive breast cancer are expected to occur among women in the United States during 2007.
