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The Food and Drug Administration (FDA) said today that the results of a Women’s Health Initiative (WHI) study on the effects of combined estrogen with progestin therapy on the incidence of dementia and memory impairment do not at this time dictate any changes to the FDA-approved uses of these drug therapies. FDA is reviewing the new information and will determine whether labeling should be updated so that women and prescribers are fully informed about use of these therapies.
In keeping with recommendations made earlier this year after the publication of the original results of the WHI study showing unexpected risks of combined estrogen and progestin, FDA emphasizes that combined estrogen and progestin is effective for treating moderate to severe symptoms of hot flashes and night sweats and the treatment of moderate to severe symptoms of vulvar and vaginal (burning, itching, and dryness in and around the vagina). However, the FDA and the current labels for these drugs advise that topical vaginal products should be considered when use of estrogen plus progestin is intended solely for the treatment of symptoms of vulvar and vaginal atrophy (burning, itching, and dryness in and around the vagina). When intended for the prevention of osteoporosis, approved non-estrogen treatments should be considered.
FDA continues to advise women to talk to their doctors, and if they decide that estrogen and progestin containing products are appropriate, they should use the lowest dose for the shortest duration to reach treatment goals, although it is not known at what dose there may be less risk of serious side effects.
FDA advises consumers and physicians that estrogen, and estrogen with progestin, have never been approved for prevention of cognitive disorders, such as Alzheimer’s Disease or memory loss.
The results of the Women’s Health Initiative Memory study (Whims) were published in today’s Journal of the American Medical Association (JAMA). FDA will be reviewing the data from this substudy of the Women's Health Initiative program (WHI), which is sponsored by the National Institutes of Health. The authors of the dementia study concluded:
The study published today included 4,500 (of the 16,000 WHI participants) women between 65 and 79 years of age; half were taking Prempro and half were on placebo.
Sixty women were diagnosed with dementia. Of these, 39 (65%) were in the estrogen with progestin group and 21 (35%) were in the placebo group. Although these findings are statistically significant, the risks to individual women are small. Participants in the study were at least 15 years older than the typical newly menopausal woman.
The WHIMS study was undertaken as a result of numerous epidemiological studies, conducted over the last decade or more that suggested that hormone therapy may reduce the risk of Alzheimer’s disease in women. It should be noted that evidence from small clinical trials had not shown effectiveness of hormone therapy in this regard. Until the full review process has been completed, FDA will not have a final conclusion on the impact of these findings on use of postmenopausal estrogen and estrogen plus progestin products. FDA will work with the manufacturers on new label information should the agency decide that it is needed. FDA will also continue to engage the National Institutes of Health (which sponsored the WHI) as well as manufacturers to pursue research on questions addressing the safe and effective use of estrogens and progestin therapies.
The other major arm of the WHI, involving women without a uterus treated with estrogen alone or placebo, is still ongoing.
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