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The FDA has approved Evista® (raloxifene hydrochloride) to cut the risk of invasive breast cancer in postmenopausal women with osteoporosis.
Evista is commonly referred to as a selective oestrogen receptor modulator.
Such drugs act by blocking oestrogen receptors in the breast, reducing the chances of women developing the disease.
Evista is only the second drug approved by the FDA to tackle the incidence of breast cancer.
Three clinical trials involving 15,234 postmenopausal women compared Evista with a placebo, and found that the drug reduces the risk of the disease by 44% to 71%.
But it can cause serious side-effects, including blood clots in the legs and lungs, and death due to stroke.
Dr Steven Galson, a director at the FDA’s Center for Drug Evaluation and Research, said: “Today’s action provides an important new option for women at heightened risk of breast cancer.
“Because Evista can cause serious side-effects, the benefits and risks of taking Evista should be carefully evaluated for each individual woman.”
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