Osteoporosis drug approved to cut breast cancer risk
Sep 15, 2007 - 1:39:25 PM
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 osteoporosis in postmenopausal women.
Evista Friday became the second drug approved to reduce the risk of breast cancer. Evista is commonly referred to as a selective oestrogen receptor modulator -. In reducing the risk of invasive breast cancer, SERMs may act by blocking oestrogen receptors in the breast.
'Today's action provides an important new option for women at heightened risk of breast cancer,' Steven Galson, director of FDA's Centre for Drug Evaluation and Research, said Friday.
'Because Evista can cause serious side effects, the benefits and risks of taking Evista should be carefully evaluated for each individual woman,' he said.
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 pre-menopausal women and women who are or may become pregnant because it may cause harm to the unborn baby, FDA warned in its statement.
In addition, Evista should not be taken with cholestyramine - or estrogens.
Evista does not completely prevent breast cancer. Breast examinations and mammograms should be done before starting Evista and regularly thereafter, said FDA.
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