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FDA News

September 9, 2003

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FDA Launches Collaborative Campaign to Inform Women About Menopausal Hormone Therapy

The Food and Drug Administration, joined by Congressman Henry Bonilla and Congresswoman Rosa DeLauro, today launched a nationwide information campaign to raise awareness about the recent findings on the risks and benefits of menopausal hormone therapy.

Last spring, Congress directed FDA to develop and execute this important information campaign targeting women through partnerships with organizations nationwide. More than ten million women use menopausal hormone therapies for relief from symptoms of menopause.

Dr. McClellan said, "Today, I want to thank Chairman Henry Bonilla, Congresswoman Rosa DeLauro, and other key members of Congress for their leadership on this important, evolving public health issue, and for helping to make sure that American women have the latest information about the safe use of menopausal hormone therapy."

"Postmenopausal hormone therapy is a major, personal decision for women, and they should be armed with the latest key facts and useful tools to make the best decision for their needs. It is very important that women realize that this beneficial therapy also carries significant risks. Our recommendation is that if you choose to use hormone therapy for hot flashes or vaginal dryness, or if you prefer it to other treatments to prevent thin bones, take the lowest dose for the least duration required to provide relief," said Dr. McClellan.

"This campaign is a great example of the good that can be achieved by non-profits, industry and governmental agencies working together to leverage resources to improve public health and save taxpayer dollars," said Representative Henry Bonilla.

"The choice of whether or not to undergo hormone therapy is a decision that will affect all women at some point in our lives. That is why it is critical that women have the information they need so they know their options and can make the right decision for them," said Representative Rosa DeLauro.

"We are pleased to see the launch of this initiative by the FDA to bring the latest scientific information to women so they can make informed decisions about using hormone therapy, said Elias A. Zerhouni, M.D., Director of the National Institutes of Health, the agency that sponsored the research that led to the new understanding of the impact of long-term hormone therapy on women's health. "As new research findings emerge, we will help incorporate them into the awareness campaign."

Working in collaboration with NIH and other Department of Health and Human Services agencies, FDA has developed science-based informational materials on its latest guidance on menopausal hormone therapies (estrogens and estrogens with progestins), and is working closely with women's health organizations, community-based organizations and other experts to get this information out to women and health-care providers.

The main tools of the campaign are a menopause and hormone-therapy fact sheet, and a purse guide that provides questions for discussion with a health professional. These materials will be available in both English and Spanish from the National Women's Health Information Center (NWHIC) at www.4woman.gov.

Menopausal hormone therapy benefits include reducing hot flashes, treating vaginal dryness, and slowing bone loss. Women need to weigh these benefits against the recent findings of increased risk of heart disease, strokes, breast cancer, and other serious health concerns associated with the use of these therapies.

The campaign, led by FDA and HHS agencies, is also being sponsored by a wide variety of participating organizations. It is designed to clarify the recent information from studies including the landmark Women's Health Initiative Study (WHI), one arm of which was halted in July 2002 due to concerns about increased risks of heart disease, stroke, breast cancer and other health concerns.

In January 2003, based on the findings of the WHI study, FDA advised women and health care professionals that menopausal hormone therapy -- estrogen and estrogen with progestin -- is associated with an increased risk of heart disease, heart attacks, strokes, and breast cancer. The warning emphasized that these products are not approved for heart disease prevention. FDA has also modified the approved indications of these menopausal hormone therapies (estrogen and progestin hormone products) to clarify that these drugs should be used only when the benefits clearly outweigh risks. As new information becomes available that affects women's health, FDA will be carefully evaluating that information to ensure that FDA-approved products remain safe and effective.

Because there are few proven alternatives for the relief of severe vasomotor symptoms and severe symptoms of vulvar vaginal atrophy, estrogens and estrogens with progestins have an important role in women's health.

Today's event is the first in a series of events being scheduled this fall to assist FDA's partners in providing up-to-date, reliable information and guidance to women, who deserve the best information possible to determine if hormone therapy is right for them.


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