A New Era in Menopause Care: The Food and Drug Administration Removes Black Box Warnings for Hormone Therapy

The Food and Drug Administration has announced one of the most significant updates in the history of menopause care. The agency is initiating the removal of long-standing black box warnings from many forms of hormone therapy used during menopause, based on a new review of the evidence and a reanalysis of data in younger women (HHS, 2025; Makary, Nguyen, Høeg, and Tidmarsh, 2025). This shift reflects current science and is consistent with guidance already shared by leading centers such as Mayo Clinic, Cleveland Clinic, Cedars Sinai, Harvard Medical School, Weill Cornell Medicine, The Menopause Society, and the British Menopause Society. For millions of women this marks the beginning of a more accurate, compassionate, and science grounded approach to menopause care.

The original boxed warning was added more than twenty years ago after early reports from the Women’s Health Initiative suggested that combination estrogen and progestogen therapy was linked to higher risks of breast cancer, stroke, and cardiovascular events in older postmenopausal women, with an average age in the early sixties (Makary et al., 2025). That trial was designed to study chronic disease prevention in older women, not symptom relief in typical midlife menopause. However, the results were applied broadly. In response, the Food and Drug Administration added boxed warnings to estrogen containing medicines, which led to a dramatic drop in hormone use and long-lasting fear among women and clinicians.

Last week the Department of Health and Human Services and the Food and Drug Administration confirmed that they are working with manufacturers to update product labeling to remove references to cardiovascular disease, breast cancer, and probable dementia from the black box section of many menopausal hormone therapies (HHS, 2025). The boxed warning will remain for systemic estrogen used alone in women who still have a uterus because of the known risk of endometrial cancer if estrogen is not balanced with a progestogen (HHS, 2025; National Cancer Institute, 2023). The Food and Drug Administration also made clear that timing matters. Women who start systemic hormone therapy within ten years of menopause onset or before sixty years of age have a more favorable benefit to risk balance than those who start later (HHS, 2025; Makary et al., 2025).

What the newer evidence actually shows

The HHS fact sheet summarizes a large body of research, including work indexed on PubMed,and highlights several key points. Studies show that starting hormone therapy within ten years of menopause onset can be associated with reduced all-cause mortality and fewer fractures (HHS, 2025). Hormone therapy has also been associated with meaningful improvements in vasomotor symptoms and quality of life and has been linked with reductions in fatal cardiovascular events, lower risk of cognitive decline, and lower risk of Alzheimer disease in women who start early in the menopause transition (HHS, 2025; Makary et al., 2025). Other analyses report that early use of menopausal hormone therapy can improve measures of vascular function, such as flow mediated dilation, and may lower rates of death and cardiovascular events when started within ten years of menopause compared to later initiation, although there can still be increased risk of stroke and venous thrombosis in some groups (Gu et al., 2024; Hodis and Mack, 2022).

Major academic and clinical institutions echo a more balanced view. Mayo Clinic and similar centers emphasize that for women under sixty, or within ten years of menopause, who do not have major contraindications, the benefits of hormone therapy often outweigh the risks, especially for moderate to severe symptoms and bone protection (Mayo Clinic, n.d.). The Menopause Society and the British Menopause Society stress individualized decision making rather than blanket fear. National Institutes of Health resources on menopausal hormone therapy and cancer underline the continued importance of understanding specific risks such as breast and endometrial cancer, and how these relate to type of hormone, dose, and duration (National Cancer Institute, 2023). The Centers for Disease Control and Prevention and the Food and Drug Administration both highlight that cardiovascular risk increases after menopause and that risk assessment and prevention should be tailored to each woman (Centers for Disease Control and Prevention, 2024; Food and Drug Administration,2024).

Why this change is so important for women

This update is not just about a label. It changes the tone of the conversation.

First, it reduces stigma and fear. For two decades many women were told, or implicitly felt, that hormone therapy was simply dangerous. As a result, they suffered with hot flashes, night sweats, insomnia, mood changes, brain fog, painful intercourse, and urinary symptoms that significantly affected daily life. By aligning labels with current evidence, the Food and Drug Administration is making room for nuanced conversations about benefit and risk rather than fear driven avoidance (HHS, 2025; Peeples, 2025).

Second, it validates what many experts have already been saying. Leading menopause specialists, including those at Mayo Clinic, Cleveland Clinic, Harvard, and Weill Cornell, along with societies such as The Menopause Society and the British Menopause Society, have argued that when hormone therapy is started in healthy women near the time of menopause, and is carefully tailored to the individual, the benefits can be substantial and the absolute risks relatively low.

Third, it supports a truly personalized model of care. The new labeling guidance encourages clinicians to consider age, time since menopause, personal and family history, choice of estrogen and progestogen, route of administration, and dose when recommending therapy (HHS, 2025; Makary et al., 2025). It also makes important distinctions between systemic therapies that circulate through the body and low dose local vaginal estrogen, which has minimal systemic absorption and is considered very safe for genitourinary symptoms (Peeples, 2025).

What women and clinicians still need to weigh

Even with the removal of many black box warnings, hormone therapy is not a one size fits all solution. Several considerations remain essential.

Women and clinicians should review personal and family history of breast cancer, endometrial cancer, blood clots, stroke, and cardiovascular disease, along with other risk factors such as smoking, obesity, and uncontrolled hypertension (National Cancer Institute, 2023; Cho et al., 2023). Choice of route matters. Transdermal estrogen and lower dose regimens may carry different risk profiles from oral preparations. Local vaginal estrogen for genitourinary syndrome of menopause has extremely low systemic levels and a different safety profile from systemic therapy, yet it was historically caught under the same warning language (Peeples, 2025).

Timing is a central factor. Evidence continues to support the concept of a window of opportunity, where women who initiate therapy before sixty years of age or within about ten years of menopause onset derive the most benefit with the least risk (HHS, 2025; Makary et al., 2025; Hodis and Mack, 2022). Beyond that window, risks may rise and benefits may be smaller, especially in women with high baseline cardiovascular risk.

Finally, removal of the black box does not mean removal of risk. The Food and Drug Administration is clear that detailed safety information remains in the prescribing information for each product. The label update is intended to make the information accurate, balanced, and reflective of current evidence, not to suggest that hormone therapy is risk free (HHS, 2025).

Why this matters for The Pause Technology and the role of SCO

For The Pause Technology, this decision lands exactly where your mission lives.

As fear and stigma decrease, more women will consider hormone therapy as one option in a broader toolkit of menopause support. That makes systems like SCO, Supportive Clinical Orchestration, even more important. SCO is the intelligent layer that helps women and their clinicians interpret real world data from wearables and digital tools, including sleep patterns, heart rate variability, temperature changes, mood tracking, and symptom logs.

With SCO, women are not left to navigate menopause alone between annual visits. Instead they can see how lifestyle choices, nutrition, stress, and hormone therapy interact in their own bodies over time. Clinicians can use objective data to support safer dosing, track response, and identify early warning signs when adjustments are needed. This aligns with the broader direction of the Food and Drug Administration, National Institutes of Health, Centers for Disease Control and Prevention, and major health systems, which are all moving toward precision medicine, prevention, and continuous risk assessment rather than one time decisions.

By integrating the best available research, guidelines from institutions such as Mayo Clinic, Cleveland Clinic, Cedars Sinai, Harvard, and Weill Cornell, and real world data through SCO, The Pause can help set a new standard for menopause care that is both deeply human and rigorously scientific.

A shared call to action from Dr Mia Chorney and Susan Sly

This moment calls for leadership, not quiet celebration.

From Dr Mia Chorney: 

Women deserve clarity, compassion, and access to accurate science, not decades old fear. The new guidance from the Food and Drug Administration is a vital step, but it is only the beginning. I invite every woman, clinician, researcher, and health leader to join us in advancing education, centering shared decision making, and expanding access to safe and effective menopause care that respects each woman’s unique story.

From Susan Sly: 

This is a historic opportunity to transform women’s health. With innovation, data informed tools, and community centered education we can change how women experience menopause, not just for this generation but for those that follow. I invite you to stand with us as we bring together technology, evidence, and human connection to support women through one of the most important transitions of their lives.

Together, Dr Mia Chorney and Susan Sly invite every reader to join in promoting education, reducing stigma, and supporting a future where women move through menopause with confidence, clarity, and continuous support that is grounded in both science and compassion.

By Dr. Mia Chorney

DNP, FNP-BC, MSCP

Co-Founder, and CMO of The Pause Technologies

References

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