Labeling changes for estrogen/progestin may be indicated following new findings.

2003 JUN 19 - (NewsRx.com & NewsRx.net) -- The U.S. Food and Drug Administration (FDA) says 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 emphasized 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.

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. When intended for the prevention of osteoporosis, approved nonestrogen 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 disease or memory loss.

The results of the Women's Health Initiative Memory Study (WHIMS) were published in the Journal of the American Medical Association. FDA will be reviewing the data from this substudy of the Women's Health Initiative program (WHI), which is sponsored by the U.S. National ...