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FDA Approves Evista to Prevent Invasive Breast Cancer

The risk and benefits of the drug should be weighed carefully, due to increased risk of clots and other adverse effects

MONDAY, Sept. 17 (HealthDay News) -- The U.S. Food and Drug Administration has approved raloxifene (Evista) for the prevention of invasive breast cancer in high-risk, postmenopausal women as well as those postmenopausal women taking the drug to prevent osteoporosis.

The risks and the benefits of the drug, which is made by Eli Lilly and Company of Indianapolis, should be weighed carefully. Raloxifene can increase the risk of clots and death due to stroke, as well as hot flashes, leg cramps, joint pain and other side effects.

The approval was based on four clinical trials. In three of them, the drug was compared to placebo in 15,234 postmenopausal women. In those trials, the risk of invasive breast cancer was 44 to 71 percent lower in Evista users. In another trial of 19,747 high-risk women, raloxifene was no different than tamoxifen in terms of ability to reduce the risk of invasive breast cancer.

"Today's action provides an important new option for women at heightened risk of breast cancer," said Steven Galson, M.D., M.P.H., director of FDA's Center for Drug Evaluation and Research, in a statement. "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."

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