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FDA Talk Paper

March 2, 2004

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FDA Plans to Evaluate Results of Women's Health Initiative
Study for Estrogen-Alone Therapy

The Food and Drug Administration said today that it plans to assess the latest results for the estrogen-alone trial of the Women's Health Initiative (WHI) study to determine whether the data supports additional labeling changes for postmenopausal hormone therapy. On March 2, 2004 the National Institutes of Health (NIH) announced that the estrogen-alone trial of the landmark WHI study is being halted because the data indicate that estrogen-alone does not affect (either increase or decrease) heart disease, the major question being evaluated in the study.

In addition, estrogen alone appears to increase the risk of stroke and decrease the risk of hip fracture. The increased risk of stroke with estrogen alone outweighs any benefits found in the study. At the same time, estrogen alone did not appear to increase the risk of breast cancer during the time period of the study. The estrogen-alone study included 11,000 healthy postmenopausal women who had had a hysterectomy.

The estrogen plus progestin trial of the WHI study was stopped in July 2002 after 5.6 years of follow-up because of an increased risk of breast cancer. The risk of breast cancer, heart disease, stroke, and blood clots observed with the estrogen plus progestin combination outweighed the benefits on hip fracture and colon cancer.

Since July 2002, FDA has been working closely with manufacturers of postmenopausal hormone therapies to update product labeling so that women along with their healthcare providers can make the best possible treatment decisions for their individual needs. The memory substudy of the WHI (WHIMS) was also halted in May 2003, after the data showed an increased risk of probable dementia in women 65 or older, and that combined estrogen and progestin therapy failed to prevent mild cognitive impairment (memory loss).

For postmenopausal women who use or are considering using estrogen or estrogen plus progestin hormone therapy, FDA continues to advise women and their healthcare providers to regularly discuss hormone therapy benefits and risks. Many manufacturers of estrogen and progestin-containing products have already revised the labeling for their products to include warnings about an increased risk of heart disease, heart attacks, strokes, and breast cancer. The FDA is continuing to work with manufacturers on updating the labeling for estrogen and estrogen with progestin-containing products as information from the WHI and WHIMS is released and reviewed. FDA is advising women that postmenopausal hormone therapy has never received approval for prevention of heart disease, or cognitive disorders such as Alzheimer's disease or memory loss.

FDA emphasizes that when estrogen-containing products are used for relief of postmenopausal symptoms such as hot flushes, they should be used only when the symptoms are moderate to severe. When used for treating moderate to severe symptoms of vulvar and vaginal atrophy, FDA urges healthcare providers to consider the use of topical products first. In addition, when estrogen-containing products are prescribed only to treat postmenopausal osteoporosis, FDA recommends that they be considered only for women at significant risk for osteoporosis and for whom non-estrogen treatments are inappropriate.

The FDA also recommends that healthcare providers use the lowest dose and the shortest treatment duration needed to achieve treatment goals.

NIH said that the report on the estrogen-alone study will be published in a peer-reviewed journal in about two months. FDA will also ensure that this information is incorporated in its "Menopause and Hormones Information Campaign," which provides information to women who are making decisions about whether to take menopausal hormone therapy.


NIH Press Release