FDA to highlight benefits and risks of hormone therapy for menopausal symptoms

Sep 29 2004

The Food and Drug Administration (FDA) is implementing a nationwide information campaign to raise awareness about the resources available to address questions related to the benefits and risks of hormone therapy for menopausal symptoms.

According to Census data from 2000, there are about 37.5 million women reaching or currently at menopause (ages 40 to 59). FDA wants women to be informed about new and emerging safety information about menopausal hormone treatment.

"Menopausal hormone therapy like all medications has benefits and risks which is why it is important for FDA to provide the latest, most helpful information to assist women in making the best decision to fit their needs," said Dr. Susan Wood, Assistant Commissioner of FDA's Office of Women's Health. She continued, "FDA's main message is: If you choose to use hormones for treating symptoms of menopause, use them at the lowest dose that helps for the shortest time needed."

The FDA and its partners are working to distribute education materials to help women make informed decisions about their health. These materials address questions of concern to perimenopausal and menopausal women considering the use of hormone therapy for relief of their symptoms. This science-based information has been developed in collaboration with the National Institutes of Health and other agencies of the Department of Health and Human Services.

The campaign helps clarify the National Institutes of Health findings from their landmark Women's Health Initiative (WHI) studies about the benefits and risks of menopausal hormone therapy. This research dramatically changed the previous knowledge base about use of hormone therapy. Women now have questions about what these findings mean for them.

The conclusions from WHI clinical studies showed that women using estrogen with or without progestin may increase their chances of strokes and blood clots. Using estrogen with progestin also increased a woman's chance of getting breast cancer and heart attacks, but using estrogen alone did not. For women with a uterus on hormone therapy, a combination of estrogen plus progestin is prescribed. Progestin prevents the overgrowth of the lining of the uterus, which can lead to cancer, a known risk of estrogen. For women who have had a hysterectomy, hormone therapy consists of estrogen alone. Using estrogen with or without progestin may increase the risk of dementia in women age 65 years or older. Estrogen, either alone or with progestin, decreased women's chances of developing weak bones. Estrogen with progestin decreased the risk of colorectal cancer in women.