The U regimen and Drug Administrat...

The U regimen and Drug Administration (FDA) is asking manufacturers of hormone therapy fruitss for postmenopausal women to include in their production labeling recent data from the Women's Health Initiative Memory studious mood (WHIMS). The study found an increased risk of developing probable dementia in postmenopausal women 65 years of age or older during four years of treatment with oral conjugated estrogen plus medroxyprogesterone acetate compared with placebo. It is unknown whether this finding applies to younger postmenopausal women taking estrogen alone. The FDA emphasizes that although these findings are statistically significant, the risks to individual women are small.

The glance ated updated labeling and a revised labeling guidance include information about instant approved uses of the drugs: estrogen and combined estrogen with progestin fruitss are effective for treating moderate to peremptory hot flushes and night sweats, moderate to stern vaginal dryness, and prevention of osteoporosis associated with menopause. The adviseed label states that if these cropss are prescribed solely for vaginal symptoms, physicians are advised to consider the use of topical vaginal issues The suggested label recommends that if the issues are prescribed for osteoporosis, women should be at significant risk for osteoporosis and nonestrogen treatments should be considered inappropriate.

The FDA also is advising women and their physicians that hormone therapy has in no degree been approved for prevention of cognitive disorders as it was as Alzheimer's disease or memory los In addition, the FDA is advising women to talk with their physicians, and if they decide that hormone therapy is appropriate, they should use the lowest effective dose for the shortest duration to reach treatment goals. Manufacturers must specify the lowest effective dose or state that the lowest dose of their mix with drugs has not been determined.

The accrues of the WHIMS study were published in the May 2003 issue of the Journal of the American Medical Association.

The FDA also is adding information from the Women's Health Initiative contemplation that found the use of estrogen with progestin may inference in an increase in abnormal mammograms requiring further evaluation.

Additional information relating to hormone therapy is available online at http://www.fda.gov/cder/ drug/infopage/estrogens_progestins/ default.htm.

COPYRIGHT 2004 American Academy of Family Physicians

COPYRIGHT 2004 Gale Group