Introduction
For more than two decades, hormone replacement therapy (HRT) has carried one of the strongest cautionary labels the U.S. Food and Drug Administration (FDA) can issue: a black box warning. This label influenced how millions of women understood menopause; how clinicians prescribed treatment; and contributed to the avoidance of therapies that, for many, could significantly improve quality of life. Last month the FDA announced that it will remove most of these warnings from menopausal hormone therapy products. This marks a profound shift in how menopause care is viewed at both regulatory and societal levels.
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The origin of the warning
To understand why this matters, it is important to revisit the origins of the warning. The black box was introduced in the early 2000s after preliminary results from the Women’s Health Initiative (WHI) suggested an increased risk of breast cancer, stroke, heart attack, blood clots, and dementia among women taking combined oestrogen-progesterone therapy. The warning painted HRT as potentially dangerous for all women, even though these risks were observed in older women many years past menopause. What is often forgotten is the population studied consisted of women with an average age of 63, which is many years past the onset of menopause and far older than the typical patient seeking treatment for vasomotor symptoms such as hot flushes or sleep disturbance. Over time, researchers began to recognise that this age mismatch had distorted public understanding. Subsequent analyses revealed that starting HRT later in life may carry different risks than beginning it around the time of menopause.
What the evidence now shows
Over the past fifteen years, evidence has consistently pointed toward the importance of timing. When hormone therapy is initiated before age 60 or within 10 years of menopause, its risk profile is far more favourable. Studies have shown lower all-cause mortality, improved cardiovascular outcomes, and meaningful symptom relief, often with fewer of the complications that dominated early headlines. Modern formulations, such as transdermal oestrogen and micronised progesterone, further refine the safety landscape.
Importantly, HRT offers substantial benefits for women navigating menopause. Treatment effectively alleviates vasomotor symptoms like hot flushes and night sweats, reduces sleep disturbance, improves mood and cognitive function, and relieves vaginal dryness and urinary discomfort. Longer-term benefits can include protection against osteoporosis, which reduces fracture risk in postmenopausal women. These quality-of-life improvements are profound, yet many women were previously deterred from seeking treatment due to fear stoked by the black box warning.
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A regulatory shift decades in the making
The FDA's decision to remove the warning reflects this scientific evolution. The agency has acknowledged that the universal risk messaging overstated potential harm for large groups of women and may have prevented appropriate treatment. Notably, one aspect of the warning will remain: the caution regarding endometrial cancer risk in women who use oestrogen-only therapy (without the uterus-protective effects of progesterone). This distinction is important, but it is also long-established clinical knowledge and does not affect the bulk of modern prescribing.
This US regulatory shift brings the country closer to the approach long taken in the UK. Unlike the United States, the UK never used a black box system, and NICE guidelines have long emphasised personalised counselling, the benefits of starting HRT near menopause, and the favourable safety profile of modern preparations. As a result, UK clinicians and patients have generally adopted a more confident view of HRT than was historically seen in the US.
What this means
For clinicians, this regulatory shift is more than a label change, it is a cultural shift. For years, many practitioners felt conflicted about recommending HRT because of the emotional weight attached to the black box. Even when they understood the nuanced evidence, the stigma surrounding hormone therapy often influenced shared decision making. Patients, understandably, were reluctant to start a treatment the FDA had once warned could increase serious health risks. The new guidance allows clinicians to have clearer, more confident conversations grounded in up-to-date science rather than outdated fear.
From a patient perspective, the change may help restore autonomy. Menopause is a deeply personal transition, and many women have suffered silently because they felt unsafe or ashamed to seek treatment. The removal of the warning does not imply that HRT is risk-free, no medical therapy is, but it does allow women to consider it through a lens of balanced information rather than anxiety. The hope is that more will feel empowered to explore options that could significantly improve their well-being. Crucially, the dismantling of this widespread fear-based messaging may also address broader implications for health equity, as women from marginalised groups often have the least access to specialist support and are disproportionately impacted by systemic barriers to care.
From our own perspective, as clinicians and researchers watching this landscape evolve, the FDA's decision feels overdue but deeply welcome. For too long, the conversation around menopause has been dominated by a narrative rooted in early-2000s findings that did not reflect the real risks and benefits most women face today. This change moves the field toward a more personalised, evidence-aligned approach; one that recognises the diversity of women's experiences and the importance of offering meaningful therapeutic choices. It also underscores a broader societal shift: menopause is finally being taken seriously as a health and quality-of-life issue, not something to be minimised or endured in silence.
Moving forward
At the same time, it is important to maintain nuance. Removing the warning should not be interpreted as a universal endorsement of HRT for everyone. The decision to start therapy must still consider individual risk factors, medical history, and personal preferences. Shared decision-making, where benefits, risks, and values are discussed openly, remains at the heart of good menopause care.
Overall, the FDA's action symbolises a new chapter. It moulds the clinical landscape, encourages more thoughtful conversation, and offers the possibility of better care for millions of women. Perhaps most importantly, it gives menopause management the modern, evidence driven framework it has needed for years.
References
FDA. FDA initiates removal of black box warnings from menopausal hormone therapy. U.S. Food and Drug Administration. 2025. Available at: https://www.fda.gov/news-events/press-announcements/fda-initiates-removal-black-box-warnings-menopausal-hormone-therapy
FDA. Labelling changes related to safety information for menopausal hormone therapy. U.S. Food and Drug Administration. 2025. Available at: https://www.fda.gov/drugs/drug-safety-and-availability/fda-requests-labeling-changes-related-safety-information-clarify-benefit-risk-considerations
Hodis HN, Mack WJ. A "window of opportunity" for estrogen therapy. Menopause. 2014;21(3):253-6.
L'Hermite M. Bioidentical menopausal hormone therapy: registered hormones only. Climacteric. 2017;20(2):91-6.
Manson JE, Chlebowski RT, Stefanick ML, et al. The Women's Health Initiative hormone therapy trials: new insights. J Clin Endocrinol Metab. 2013;98(4):1581-92.
Manson JE, Chlebowski RT, Stefanick ML, et al. Menopausal hormone therapy and long-term all-cause and cause-specific mortality. JAMA. 2017;318(10):927-38.
North American Menopause Society. 2023 Position Statement on Menopausal Hormone Therapy. 2023. Available at: https://www.menopause.org/publications/position-statements
Rossouw JE, Anderson GL, Prentice RL, et al. Risks and benefits of estrogen plus progestin in healthy postmenopausal women. JAMA. 2002;288(3):321-33.
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