September 15, 2007 - The U.S. Food and Drug Administration, the U.S equivalent to Saudi Food and Drug Authority (SFDA) has approved new indication of Evista (raloxifene hydrochloride) for reducing the risk of invasive breast cancer in postmenopausal women with osteoporosis and in postmenopausal women at high risk for invasive breast cancer. Evista is only the second drug approved to reduce the risk of breast cancer.

Evista is commonly referred to as a selective estrogen receptor modulator (SERM). In reducing the risk of invasive breast cancer, SERMs may act by blocking estrogen receptors in the breast.

This action was taken following the FDA’s Oncology Drugs Advisory Committee meeting on July 24, 2007 which resulted in recommending the approval of Evista for reducing the risk of invasive breast cancer in postmenopausal women with osteoporosis and in women at high risk for breast cancer.

Three clinical trials in 15,234 postmenopausal women comparing Evista to placebo (no drug) demonstrated that Evista reduces the risk of invasive breast cancer by 44 to 71 percent. A fourth clinical trial in postmenopausal women at high risk for developing breast cancer compared Evista to tamoxifen. In this trial, the risk of developing invasive breast cancer was similar for the two treatments. The clinical trials were conducted over the last 10 years.

Evista can cause serious side effects including 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 premenopausal women and women who are or may become pregnant because it may cause harm to the unborn baby. In addition, Evista should not be taken with cholestyramine (a drug used to lower cholesterol levels) or estrogens.

Evista was approved in Saudi market in year 2000 as a treatment of osteoporosis in postmenopausal women.

The SFDA advises prescribers that benefits and risks of taking Evista should be carefully weighed in each individual woman. Evista does not completely prevent breast cancer. Breast examinations and mammograms should be done before starting Evista and regularly thereafter.