“Menopause Liberation Day” — November 10, 2025: The FDA’s Removal of the Black Box Warning on Hormone Replacement Therapy — and What It Means for Women’s Health and Longevity
- Octavian M. Belcea, MD
- Nov 11
- 3 min read
For millions of women, hormone replacement therapy (HRT) was once a key part of vitality. But for more than two decades, fear has overshadowed its benefits, until now.
November 10, 2025, marks a historic milestone in women’s health: the day the FDA officially removed the black box warning on hormone replacement therapy. This decision, now being referred to as “Menopause Liberation Day,” signals a new era of science-based empowerment for women navigating midlife and beyond.
A Major Shift from the FDA
November 10, 2025 — “Menopause Liberation Day.” On this date, the FDA officially announced it would remove the long-standing black box warning that has accompanied systemic estrogen products since 2003. It marks the end of an era of fear and misinformation surrounding hormone therapy, and the beginning of a more balanced, evidence-based conversation about women’s health.
FDA Commissioner Dr. Marty Makary explained why in a recent interview:
“The fear machine started in 2003 after a 2002 study scared women out of hormone replacement therapy... But when the study results were finally released, there was no statistically significant increased risk of breast cancer. There was actually a lower rate of breast cancer in the estrogen-only group.”
The “study” he refers to is the original Women’s Health Initiative (WHI), a landmark trial that changed how an entire generation of doctors viewed estrogen. Unfortunately, its results were overgeneralized and misinterpreted.
“The cardiovascular benefits are profound when hormone replacement therapy is started within 10 years of the onset of menopause,” Dr. Makary noted. “But unfortunately, fear has dominated the field, and women have been denied or never offered hormone replacement therapy despite the profound short-term and long-term benefits.”
Why the Warning Is Being Removed
The FDA’s review incorporated more than 20 years of follow-up data and meta-analyses. The new labeling will:
Remove boxed warnings related to cardiovascular disease, breast cancer, and dementia for systemic estrogen therapies.
Retain a boxed warning about endometrial cancer risk when estrogen is used without progesterone in women with an intact uterus.
“We’re removing those warnings and putting the nuances of the risks in the package insert,” Makary explained. “The idea is to get better information in front of women.”
The Benefits: Both Short- and Long-Term
Starting HRT can offer a range of benefits:
Relief from vasomotor symptoms: hot flashes, night sweats, sleep disruption, mood changes, vaginal dryness.
Improved bone density and 50–60% fewer fractures later in life (NEJM data).
Reduced cognitive decline by ~64% and up to 35% lower Alzheimer’s risk in some studies.
Cardiovascular protection, with up to 30–50% reduction in heart disease when begun early.
“It keeps blood vessels soft and healthy,” Makary said. “When started too late, the vessels may already have narrowed, and that’s when risk rises.”
Who Should Not Use HRT
HRT isn’t right for everyone. Contraindications include:
Active or recent breast cancer (though nuance exists by receptor type and recurrence risk).
Known clotting disorders or history of venous thromboembolism (unless managed on with blood thinners).
Uncontrolled liver disease.
Unexplained vaginal bleeding.
“The vast majority of women who go through menopause are great candidates,” Makary emphasized. “But if a woman has a uterus, it’s important she also take progesterone to reduce the risk of endometrial hyperplasia.”
Final Thoughts
“Menopause Liberation Day” (November 10, 2025) will be remembered as the day the FDA ended a 22-year chapter of misplaced fear. The removal of the black box warning on HRT marks a turning point in women’s health. It’s a recognition that risk is nuanced, context-dependent, and deeply personal. For millions of women, it re-opens a door that never should have been closed.
As physicians focused on longevity, we should help women not merely live longer but create more good years of vitality, clarity, and strength.
To Your Good Health,
The Longevity Doctor®
It's going to be very interesting to see if studies of the psychological benefits come out in the coming years. I'm curious if it will help reduce unnecessary stress and allow more room for creativity and inner peace.