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This is a revised version of FDA Press Release P04-94, originally issued September 29, 2004.
The phone number in the second-to-last paragraph has been changed.
Contact: Alice Fisher
Alice Fisher [afisher@themedianetwork.com]
1-800-565-4352
| FOR IMMEDIATE RELEASE |
Media Inquiries: 301-827-6242 |
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.
Some of the important questions answered in the FDA education materials include examples such as:
"What are the benefits of using hormones for menopause?" Menopausal hormone therapy is the most effective FDA approved medicine for relief of hot flashes, night sweats, and vaginal dryness. For some women, menopausal hormone therapy may also reduce the chances of getting weak bones, a condition called osteoporosis. (For women at high risk of osteoporosis, other medications to prevent bone loss should be considered.)
"What are the risks of using hormones?"
For some women, menopausal hormone therapy may increase their chances of getting blood clots, heart attacks, strokes, breast cancer, and gall bladder disease. For a woman with a uterus, estrogen alone slightly increases her chance of getting endometrial cancer (cancer of the uterine lining).
The FDA continues to initiate information and education outreach activities regarding hormone therapy for menopause. Materials, such as printable brochures and a list of questions to take to doctor visits, are downloadable directly from the Internet at the following website location, www.fda.gov/womens/menopause/. In conjunction with help from its national partners, FDA's English and Spanish hormone therapy materials will help women:
The FDA website lists informational resources, such as government agencies, private organizations, newsletters, magazines, and reports for women seeking more information about menopause at the following location: www.fda.gov/cder/drug/infopage/estrogens_progestins
Further information can be located on the Internet at www.4women.gov/Menopause/resources.htm. Organizations wishing to partner with the FDA, or those who wish to order English or Spanish materials may contact the National Women's Health Information Center (NWHIC) at (800) 994-9662. NWHIC is a service of the HHS Office of Women's Health.
The FDA, an agency of the Department of Health and Human Service (HHS), has partnered with other HHS agencies, as well as not for profit women's health organizations and professional associations. Currently, there are approximately 30 FDA partners helping to increase women's awareness about the use of menopausal hormone therapy.
Susan F. Wood, PhD, Assistant Commissioner for Women's Health, FDA Office of Women's Health, and Joseph Kaczmarczyk, DO, MPH, Medical Officer, FDA Office of Women's Health, are available as part of National Menopause Awareness Month, to discuss the benefits and the risks of using hormones for menopause and provide helpful resources to women concerning FDA's campaign.
To schedule an interview with either Dr. Wood, or Dr. Kaczmarczyk, contact Alice Fisher at 1-800-565-4352.
The U.S. Food and Drug Administration's Office of Women's Health (OWH) serves as a champion for women's health. It monitors progress of priority women's health initiatives within the FDA; It promotes an integrative and interactive approach regarding women's health issues across all the organizational components of the FDA; and it forms partnerships with government and non-government entities, including consumer groups, health advocates, professional organizations, and industry, to promote FDA's women's health objectives.
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