Evista Approved to Reduce the Risk of Breast Cancer In Postmenopausal Women

The U.S. Food and Drug Administration has recently approved Evista (raloxifene hydrochloride) for reducing the risk of invasive breast cancer in postmenopausal women with osteoporosis and in postmenopausal women at high risk for breast cancer. Evista is only the second drug approved to reduce the risk of breast cancer. Tamoxifen was the first.

Evista has been on the market since 1997. It has been used for the prevention and treatment of osteoporosis.


The decision to approve Evista for this new indication was based on several large clinical trials. In one trial involving about 15,000 postmenopausal women, Evista was shown to reduce the risk of invasive breast cancer by 44 to 71 percent when compared to placebo. In another study of almost 20,000 women with high risk for breast cancer, Evista was compared to Tamoxifen. Evista was equal to Tamoxifen in preventing breast cancer.


A recent trial found that Evista does not raise the incidence of stroke, but does the incidence of death due to stroke. A boxed warning now says "women with an active or past history of venous thromboembolism should not take EVISTA.. Women at risk for stroke should receive EVISTA only after evaluating the risk-benefit balance with their healthcare providers."



References: U.S. Food and Drug Administration.