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Raloxifene Approved for Lowering Breast Cancer Risk in Postmenopausal Women

The FDA has approved a second SERM for breast cancer chemoprophylaxis.

In September 2007, the FDA approved the selective estrogen receptor modulator (SERM) raloxifene (Evista) for reducing the risk for breast cancer in two groups of postmenopausal women:

• Those with osteoporosis
  
• Those at high risk for breast cancer
  

The SERM tamoxifen is the only other agent approved for breast cancer chemoprophylaxis. In women with a uterus, use of tamoxifen is associated with vasomotor symptoms, elevated risk for venous thromboembolism (VTE), and uterine effects (bleeding, growth of fibroids and endometrial polyps, and an elevated risk for endometrial cancer). Raloxifene is also associated with VTE and vasomotor symptoms; moreover, raloxifene has been associated with an increased risk for fatal stroke (Journal Watch Women’s Health Jul 27 2006). In contrast to tamoxifen, raloxifene does not cause uterine bleeding or endometrial neoplasia. Raloxifene is effective in preventing vertebral fractures in menopausal women. However, unlike hormone therapy and the bisphosphonates alendronate and risedronate, raloxifene has not been found to prevent nonvertebral (including hip) fractures (Journal Watch Women’s Health Oct 1 1999).

Comment: Many effective drugs are available for the treatment of osteoporosis, and raloxifene’s side effects limit its appeal for use in healthy women at high risk for breast cancer. Nonetheless, having a new option that can reduce risk for this malignancy is desirable for such women.

— Andrew M. Kaunitz, MD

Published in Journal Watch Women's Health September 27, 2007

Citation(s):

U.S. Food and Drug Administration (FDA). FDA Approves New Uses for Evista. 2007 Sep 14 . (http://www.fda.gov/bbs/topics/NEWS/2007/NEW01698.html)