FDA’s Hormone Replacement Shift Is a Turning Point for Women
Publication: Everyday Health
Date Published: December 5, 2025
Author(s): Liz Plosser
Medically Reviewed By: Kara Smythe, MD
News Analysis & Summary
The FDA’s decision to remove the long‑standing black box warning from most menopausal hormone therapy products marks a major shift in women’s health.
For over 20 years, women were told hormone therapy carried broad, serious risks, based largely on early interpretations of the WHI study. The Women’s Health Initiative (WHI) was a massive, long‑term study of over 160,000 postmenopausal women that reshaped women’s health by examining how hormone therapy, diet, and supplements affect risks for heart disease, cancer, and osteoporosis.
The WHI’s biggest problem was that it studied older, less‑healthy women using outdated hormone formulations and then generalized those results to all menopausal women, creating decades of misleading fear about hormone therapy. Updated evidence now shows that risks depend on age, timing, and individual health history, meaning millions of women may finally get access to symptom relief without outdated fear shaping their care
Clinical Insights
Why Did the FDA Remove the Black Box Warning Now?
Because two decades of updated research show that risks vary by age, timing, and health history; not all hormone therapy carries the same level of risk.
What Was Wrong With the Original WHI Interpretation?
The early WHI results were applied broadly, even though the study population was older and not representative of women newly entering menopause, leading to decades of fear and under‑treatment.
Does Hormone Therapy Still Carry Risks?
Yes, but the risks are now understood to be individualized. Estrogen‑only therapies still carry a black box warning for endometrial cancer, and decisions should be made with a trained menopause provider.
How Does This Change Women’s Access to Care?
The shift removes a major psychological and clinical barrier, allowing more women to have informed conversations with knowledgeable clinicians instead of being dismissed or told therapy is universally dangerous.
What Does Tamsen Fadal Say This Means Culturally?
She calls it a turning point: a public acknowledgment that women’s midlife symptoms were real, under‑recognized, and underserved for decades.
What Should Women Look for in a Provider Now?
Fadal emphasizes avoiding clinicians who dismiss symptoms as “normal aging” or who categorically refuse hormone therapy; she urges women to seek menopause‑trained specialists.
How Does Timing Affect Safety?
Experts note that starting hormone therapy before age 60 or within 10 years of menopause is associated with safer outcomes and potential benefits for heart, bone, and brain health
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