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Data on cognition: new HT labeling requested by FDA.(Gynecology)
Black box warnings on hormone therapy products prescribed for postmenopausal women should be updated to include data from a recent trial suggesting that combination therapy does not prevent mild cognitive impairment, the Food and Drug Administration has advised.
The labeling advice reflects findings from the Women's Health Initiative Memory Study (WHIMS)--a substudy of the Women's Health Initiative (WHI)--which demonstrated an increased risk of dementia in women 65 and older during 4 years of treatment with oral conjugated estrogens plus medroxyprogesterone acetate, compared with placebo. The study also showed that the combination therapy failed to prevent mild cognitive impairment (JAMA, 289[20]:2663-72, 2003).
The existing black box warning on estrogen/progestin products contains WHI information about increased cardiovascular risks associated with the agents.
The FDA is asking that labels also explain that estrogen-only and combined estrogen-progestin products are effective for treating moderate to severe hot flashes, night ...
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Source: HighBeam Research, Data on cognition: new HT labeling requested by FDA.(Gynecology)