Case Evaluation

Prempro: FDA Requests Revised Hormone Therapy Labeling

Feb. 10, 2004 -- The FDA is asking manufacturers to update labeling for hormone therapy products prescribed for postmenopausal women. The new labeling will reflect findings from the NIH-funded Women's Health Initiative Memory Study, which reported an increased risk of dementia in women 65 and older. The study showed that products like Prempro, which contain estrogen and progestin, failed to prevent mild memory loss.

The existing "black box" on estrogen/progestin products contains information on increased risks for heart disease, heart attacks, strokes, and breast cancer. The warning also emphasized that these products are not approved for heart disease prevention.

Among its suggestions, the FDA asked that labels explain:

  • Current approved uses of the drugs -- specifically, that estrogen-only and combined estrogen-progestin products are effective for treating these menopausal symptoms: moderate to severe hot flashes and night sweats, moderate to severe vaginal dryness, and prevention of osteoporosis associated with menopause.
  • That, if these products are prescribed solely for vaginal symptoms, health care providers are advised to consider the use of topical vaginal products.
  • That, if the products are prescribed for osteoporosis, women should be at significant risk for osteoporosis and not appropriate candidates for non-estrogen treatments.

The FDA is also advising women and their health care providers that menopausal hormone therapy has never been approved for prevention of cognitive disorders such as Alzheimer's disease or memory loss.

"Postmenopausal women need to know about recent results of the Women's Health Initiative, because this information can have a significant public health impact," says FDA Commissioner Mark McClellan, MD, PhD, in a statement.

"After thoroughly evaluating the WHIMS data, FDA is updating the risk and benefit information in product labels to help women and health professionals make informed choices about hormone therapies," he says.

If women decide that hormone therapy is appropriate, they should use the lowest effective dose for the shortest time, the FDA advises.

Evidence About Estrogen

The FDA based its action on study results published in the May 2003 Journal of the American Medical Association (JAMA). The study included 4,500 women 65 to 79 years old; half were taking Prempro and half were taking a placebo. Sixty of these women were diagnosed with dementia. Of these, 39 women (65%) were in the estrogen-progestin group and 21 women (35%) in the comparison group. The FDA says that these findings represent a small risk to the individual woman.

The participants in the study were at least 15 years older than the typical newly menopausal woman. The FDA has also advised manufacturers to add the following information to the clinical studies section: "The use of estrogen with progestin may result in an increase in abnormal mammograms requiring further evaluation." Hormone therapy manufacturers must specify the lowest effective dose or state that the lowest dose of their drug has not been determined.

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