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Menopausal Hormone Therapy

A nationwide campaign led by the Food and Drug Administration and other Department of Health and Human Services agencies seeks to provide better health information to women about the use of hormones to treat symptoms of menopause.

FDA Commissioner Mark B. McClellan, M.D., Ph.D., and several members of Congress announced the menopausal hormone therapy campaign in September 2003. The collaborative campaign is aimed at raising awareness about recent findings on the risks and benefits of menopausal hormone therapy and making sure that women have the latest information about the safe use of FDA-approved drugs to relieve menopausal symptoms.

"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," says McClellan.

In the spring of 2003, Congress directed the FDA to develop and execute this important information campaign through partnerships with organizations nationwide. More than 10 million women use menopausal hormone therapies (estrogen or estrogen with progestin) for relief from symptoms of menopause.

"The choice of whether or not to undergo hormone therapy is a decision that will affect all women at some point in our lives," says Rep. Rosa DeLauro, D-Conn. "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."

The campaign is designed to clarify the recent information from studies, including the Women's Health Initiative (WHI) study sponsored by the National Institutes of Health (NIH). One arm of the WHI was halted in July 2002 due to concerns about increased risks of some health problems. The study has led to new understanding of the impact of long-term hormone therapy on women's health.

In January 2003, based on the findings of the WHI study, the FDA advised women and health care professionals that menopausal hormone therapy 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.

Because there are few proven alternatives for the relief of hot flashes and vulvar and vaginal atrophy (burning, itching and dryness in and around the vagina), menopausal hormone therapies have an important role in women's health. "It is very important that women realize that this beneficial therapy also carries significant risks," says McClellan. "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."

The FDA has modified the product labeling of menopausal hormone therapies 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, the FDA will be carefully evaluating that information to ensure that FDA-approved products remain safe and effective.

Working in collaboration with the NIH and other HHS agencies, the FDA has developed science-based materials on its latest guidance on menopausal hormone therapies. The FDA is working closely with a wide range of cosponsoring organizations, including women's and community-based health and advocacy organizations, to get this information out to women and health care providers. "This campaign is a great example of the good that can be achieved by nonprofits, industry and governmental agencies working together to leverage resources to improve public health and save taxpayer dollars," says Rep. Henry Bonilla, R-Texas.

The main tools of the campaign are a menopause and hormone-therapy fact sheet and a purse-size guide that gives women questions they can discuss with their health professionals. These materials are available in both English and Spanish from the National Women's Health Information Center at

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Questions for Your Doctor, Nurse or Pharmacist

  1. Are hormones right for me? Why?
  2. Are there other things I can use or do?
  3. What are the benefits and risks?
  4. How long should I use hormone therapy?
  5. What is the lowest dose that will work for me?
  6. What are the side effects?
  7. If I want to stop hormones, how should I do that?
  8. When should I be checked for:
  9. Do you have any advice to help me:


When using hormone therapy for menopause

  • Use at the lowest dose that helps
  • Use for the shortest time needed

Reprinted from FDA Consumer. This article originally appeared in the November -December 2003 FDA Consumer.


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