US EditionFDA Commissioner Stirs Debate over Hormone Therapy for Menopause
UNITED STATES, JUL 22 – The FDA panel cited new research showing hormone therapy is safe and urged removing warnings that have reduced treatment use from 40% to 5% since 1999.
- Last week, an FDA advisory panel recommended removing outdated 'black box' warnings from topical estrogen menopause treatments, aiming to improve access and safety.
- The 2002 Women’s Health Initiative study led to black box warnings, with risks mainly found in older women, according to later research.
- The randomized controlled trial in the 1990s studied estrogen on more than 10,000 women and estrogen-progestin on over 16,000 women, The Hill reported; Rachel Rubin warned, `'This label scares patients and clinicians every day'`, highlighting barriers to care.
- Advocates warn that outdated warnings continue to block many women from receiving menopause care; if the FDA updates the warning language, women could gain easier access to safe, effective relief.
- The panel’s recommendation is part of a broader push to fix long-standing gaps in menopause education and care; Heather Hirsch, MD, emphasized, `Vaginal or local estrogen is categorically safe for all women, period`, highlighting benefits like protection against heart disease and fractures.
13 Articles
13 Articles
When Isabel Farias Meyer was diagnosed with primary ovarian insufficiency (IOP) – known as early menopause – she was 17 years old. She learned this after several medical studies and having experienced irregularities in her menstrual cycles, drastic weight rises and drops, and emotional instability. No woman within her environment had had this condition, so what followed was a path of confusion: “I had not enough information, I had no answers, I …
'All of us are begging': New push for FDA to remove 'black box' warnings from menopause products
The debate over whether to use hormone therapy to treat menopausal women continues, as a Food and Drug Administration (FDA) expert panel weighs in. The panel, consisting of 12 people, is urging the use of such treatments and asking the FDA to remove “black box” warnings from the products. It has long been argued whether the listed side-effects of such hormone replacements are overblown, while some claim that long-term effects are worthy of some …
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