The drug, produced by U.S.-based Eli Lilly, can lower the risk of invasive breast cancer in postmenopausal women with osteoporosis and those at high risk for invasive breast cancer, U.S. Food and Drug Administration (FDA) said Friday.
"Today's action provides an important new option for women at heightened risk of breast cancer," says Steven Galson, director of the FDA's Drug Evaluation and Research, in an FDA news release.
According to Lilly spokeswoman Sharon Corbitt, the company applied for the new use after conducting studies on about 37,000 postmenopausal women. Evista was introduced in 1998 for the prevention and treatment of osteoporosis.
It is the second drug to tamoxifen which received the FDA approval in the United States to reduce breast cancer risk in women. Evista comes with few side effects such as blood clots in legs and lungs, which can cause deadly stroke.
Breast cancer is the second leading cause of cancer deaths among women in the United States. It accounts for 26 percent of all cancers among U.S. women.
FDA regulators have also warned that the benefits and risks of taking Evista should be carefully evaluated for each individual woman because of its side effects.
"Women should talk with their health care provider about whether the drug is right for them," says Galson.
The company warns women who are pregnant or of the child bearing age against the use the drug. Evista also shouldn't be taken with cholestyramine (a drug used to lower cholesterol levels) or estrogens.
