Authors: Rhea Manohar, MPH; Jacqueline Ugwuneri, Chelsea Oppong, MS; Meghan Etsey, Dr. Teresa Lazar on behalf of the AMWA Gender Equity Task Force

On November 10th, 2025, the U.S Department of Health and Human Services (HHS) announced its historic motion to initiate the removal of black box warning from hormone replacement therapy (HRT) products for menopause. After more than two decades of concerns regarding HRT, the U.S. Food and Drug Administration (FDA)  conducted a comprehensive review of scientific literature, an expert panel, and public commentary to address the risks and benefits related to menopause and hormone therapy. The motion to remove the black box warning is part of the FDA’s effort to understand various perspectives on the safety considerations and the use of hormone therapy for menopause-related conditions in clinical practice (FDA, 2025; Lupkin, 2025). 

For many women, menopause isn’t just a medical milestone; it’s a daily reality of disruptive symptoms, limited treatment options, and long standing fear shaped by decades of conflicting information. Hot flashes, sleep disturbances, mood changes, and genitourinary symptoms can affect work, relationships, and overall quality of life. The black box warning present on HRT products for over twenty years has contributed to widespread hesitation among both patients and clinicians, leaving many women untreated or undertreated. When the FDA recently moved to remove the black box warning, it sparked a surge of uncertainty,  questions, and a need for clarity. Possible questions being: What does this actually mean? Is HRT considered safe now? What are some things to consider? How can I discuss this with my doctor?

When the FDA initially issued its black box warning on hormone replacement therapy, it was in response to evidence that rightfully warranted caution. The Women’s Health Initiative (WHI) trial, one of the largest randomized controlled studies of its kind, linked systemic estrogen-progestin therapy with increased risks of breast cancer, stroke, and cardiovascular events in postmenopausal women (Manson et al., 2024). These findings prompted a sweeping regulatory response: one that extended the warning to all estrogen-containing products, regardless of route, formulation, or dose. For decades, that warning shaped both clinical practice and public perception, casting a long shadow over the use of HRT for menopause symptom relief.

Yet, science and medicine rarely stand still, rather, they are ever changing and evolving, and scientists and clinicians work to improve care for all patients. Over the past two decades, a more nuanced understanding of hormone therapy has emerged, reframing both its risks and its role in care. The early WHI participants had a mean age of 63 years, well past the typical age of menopause onset, and subsequent analyses revealed that the greatest risks occurred when therapy began more than ten years after menopause (Manson et al., 2024). In contrast, more recent data indicate that for women under 60, or within a decade of menopause onset, the absolute risks of adverse cardiovascular or oncologic outcomes are substantially lower (Chang et al., 2023). Estrogen therapy remains the most effective treatment for vasomotor and genitourinary symptoms, and in women who have undergone hysterectomy. This evolving evidence has led professional organizations, including the American College of Obstetrics and Gynecology (ACOG) and the North American Menopause Society, to support individualized risk assessment, shared decision-making, and symptom-targeted use of HRT rather than its blanket avoidance (ACOG, 2024; The North American Menopause Society, 2023).

The persistence of the FDA’s black box warning underscores the lag between evolving evidence and regulatory change. Despite limited systemic absorption with low-dose vaginal preparations, these localized treatments continue to carry the same warning as systemic estrogen, a decision rooted in class labeling rather than trial-based data (Crandall et al., 2023). For patients, this creates confusion and fear, often deterring effective treatment for symptoms that profoundly impact quality of life. For clinicians, it reinforces the need for clear communication, contextualized risk discussions, and advocacy for evidence-based labeling that reflects current science.

While newer data highlight that hormone therapy can be safe and beneficial for many women when started near menopause, potential side effects still warrant thoughtful consideration. Systemic therapy may cause transient breast tenderness, bloating, or irregular bleeding, and carries uncommon risks such as venous thromboembolism, gallbladder disease, or, with certain formulations, increased breast cancer risk. These risks are typically small in healthy women under 60 and can be minimized through individualized treatment planning and regular follow-up (Manson et al., 2024; US Preventive Services Task Force, 2022; Yanachkova et al., 2025).

The most common patients receiving HRT are postmenopausal women, primarily those seeking relief from moderate to severe vasomotor symptoms such as hot flashes and night sweats, or postmenopausal women seeking preventative methods against osteoporosis when other therapies are unsuitable (Huang et al., 2024; US Preventive Services Task Force, 2022). The FDA’s new recommendation will be to start HRT within 10 years of menopause onset or before 60 years of age for systemic HRT. For these patients, the change means a more individualized approach to treatment, with a foundational holistic approach. While the new recommendation does not mean HRT is risk-free, it allows patients to engage in shared decision making and explore treatment options. It is highly recommended that clinicians carefully weigh the benefits of symptom relief against the potential harm, especially in patients with existing comorbidities and risk factors such as breast cancer and cardiovascular disease. Periodic assessment is highly recommended, and HRT should be discontinued when no longer needed (Crandall, et. al., 2023). 

Myth Debunking:

While the use of HRT for menopause care is a critical step towards increasing treatment and care for an often overlooked population, understanding the misinformation and contraindications is critical. 

  1. HRT use for Cardiovascular Disease: Notably, information was recently presented regarding the use of HRT to prevent coronary disease, but no data has currently been found to support the treatment protocol (Chang et al., 2023). 
  2. HRT use for Dementia: Currently, no conclusive evidence exists noting HRT’s use as a protective mechanism for Alzheimer’s disease. Although some studies indicate that estrogen alone may provide some benefit, others note that the combined estrogen and progesterone HRT may not have similar benefits (Nerattini et al, 2023).
  3.  Estrogen rates of breast cancer risks: Further research needs to be conducted to evaluate the risks and benefits of estradiol, (the common form of estrogen used), varied risk rates for different age groups of women, and the protective difference between estrogen alone compared to combined estrogen and progesterone uses (Manson et al., 2024).
  4.  All forms of HRT carry the same level of risk: Low-dose vaginal estrogen has minimal systemic absorption and does not carry the same cardiovascular or cancer risks as systemic formulations, despite the previously shared FDA black box warning. (ACOG, 2023; North American Menopause Society, 2023)

With so much information online, it can feel overwhelming. But here’s a simple way to digest the FDA’s updated stance. The risks exist, but they’re better understood now:

  1. The benefits of HRT are real and can be life-changing.
  2. The decision should be individualized and cater to your needs, reflecting symptoms, health history, and preferences. 
  3. Timing matters: Starting HRT within 10 years of menopause or before age 60 carries the lowest risk. 
  4. Not all HRT is the same: Local therapies like low-dose vaginal estrogen behave differently in the body than systemic hormones.
  5. Science evolves and that’s a good thing! Recommendations change as new evidence emerges, and these updates are meant to improve safety and care, not cause fear.
  6. Shared decision making is essential. You deserve a collaborative conversation with your clinician about your symptoms, goals, risks, and alternatives.

Here are a few questions you can bring to your next appointment with your provider:

  1. “Based on my age and health history, am I a good candidate for HRT?”
  2. “What specific risks apply to me, and how can we minimize them?”
  3. “How will we monitor symptoms and adjust treatment?”

The story of hormone therapy has evolved from one of caution to one of informed optimism. The original FDA warning reflected the best available science of its time, but ongoing research has transformed our understanding of risk, benefit, and biological nuance. Today, HRT represents not a source of fear, but a symbol of how science advances by refining its own lessons to better serve patients. For women navigating menopause, this progress offers both clarity and empowerment: relief from symptoms that have too long been stigmatized or dismissed, and renewed confidence that treatment decisions can be grounded in individualized, evidence-based care.

As medicine continues to reexamine old assumptions, the trajectory of HRT stands as a hopeful reminder that scientific inquiry is not static, but it listens, corrects, and evolves. The path forward lies in aligning policy with emerging data and ensuring that women are not left behind in that process. In this way, the ongoing reevaluation of hormone therapy is more than a regulatory shift, but a testament to the power of research to restore trust, expand choice, and advance women’s health with the dignity and precision it deserves.

References: 

  1. Chang, J. G., Lewis, M. N., & Wertz, M. C. (2023, July 15). Managing menopausal symptoms: Common questions and answers. American Academy of Family Physicians. https://www.aafp.org/pubs/afp/issues/2023/0700/menopausal-symptoms.html 
  2. Crandall, C. J., Mehta, J. M., & Manson, J. E. (2023, February 7). Management of menopausal symptoms: A review | gynecology | JAMA | jama network. JAMA Network. https://jamanetwork.com/journals/jama/article-abstract/2801054 
  3. Huang, A. J., Faubion, S., & Grady, D. (2025). Nonhormonal Treatment of Menopausal Vasomotor Symptoms. JAMA internal medicine, 185(7), 874–875. https://doi.org/10.1001/jamainternmed.2025.0990 
  4. Lupkin, S. (2025, November 11). FDA commissioner on lifting warnings on hormone therapy for Menopause. NPR. https://www.npr.org/sections/shots-health-news/2025/11/10/nx-s1-5604283/fda-menopause-hormone-therapy 
  5. Manson, J. E., Crandall, C. J., & Rossouw, J. E. (2024, May 1). The Women’s Health Initiative Randomized Trials and Clinical Practice. JAMA Network. https://jamanetwork.com/journals/jama/article-abstract/2818206 
  6. Nerattini, M., Jett, S., Andy, C., Carlton, C., Zarate, C., Boneu, C., Battista, M., Pahlajani, S., Loeb-Zeitlin, S., Havryulik, Y., Williams, S., Christos, P., Fink, M., Brinton, R. D., & Mosconi, L. (2023). Systematic review and meta-analysis of the effects of menopause hormone therapy on risk of Alzheimer’s disease and dementia. Frontiers in aging neuroscience, 15, 1260427. https://doi.org/10.3389/fnagi.2023.1260427 
  7. US Preventive Services Task Force. (2022, November 1). Hormone therapy for the primary prevention of chronic conditions in postmenopausal persons: US Preventive Services Task Force recommendation statement | gynecology | JAMA | jama network. JAMA Network. https://jamanetwork.com/journals/jama/fullarticle/2797867 
  8. U.S. Food and Drug Administration. (2025, July 17). FDA Expert Panel on Menopause and Hormone Replacement Therapy, https://www.fda.gov/patients/fda-expert-panels/fda-expert-panel-menopause-and-hormone-replacement-therapy-women-07172025 
  9. Yanachkova, V., Vasileva-Slaveva, M., Kostov, S., & Yordanov, A. (2025). Reconsidering Hormone Replacement Therapy: Current Insights on Utilisation in Premenopausal and Menopausal Women: An Overview. Journal of clinical medicine, 14(20), 7156. https://doi.org/10.3390/jcm14207156
  10. The American College of Obstetricians and Gynecologists (ACOG). Practice Bulletin No. 141: Management of Menopausal Symptoms. Obstet Gynecol. 2014;123(1):202–216 
  11. The North American Menopause Society. The 2023 Hormone Therapy Position Statement of The North American Menopause Society. Menopause. 2023;30(7):742–759.  

About the Authors

Rhea Manohar, MPH, MS3

Rhea Manohar is a third year medical student from St. George’s University. She has a Masters in Public Health with a concentration in Maternal and Child Health from George Washington University Milken Institute of Public Health and a Bachelors of Science in Microbiology, Immunology, and Public Health from the University of Miami. She served as Co-VP of OB/GYN Education for St. George’s University’s Women in Medicine chapter in St. George, Grenada where she developed and implemented hands-on workshops to further reproductive health issues and bolstered medical students abilities to navigate physician-patient communication. Prior to medical school, she was a Research Associate for Fors Marsh Group, where she led qualitative and quantitative public health research and campaign development for federal agencies (e.g., CDC, NIH, DHHS, CPSC). She is also a member of the Gender Equity Task Force and Reproductive Health Coalition within the American Medical Women’s Association. When she is not pursuing medicine, you can find her reading, exploring artistic passions, and spending time connecting with friends and family.

Jacqueline Ugwuneri, MS3

Jacqueline Ugwuneri is a third-year medical student at St. George’s University School of Medicine. She earned her Bachelor of Arts in Cognitive Science with a concentration in Cognitive Neuroscience from Rutgers University in New Brunswick, NJ. She served as President of the St. George’s University chapter of the Student National Medical Association (SNMA), where she organized mentorship programs, health fairs, and professional development events that fostered community engagement and empowered minority medical students to thrive both academically and personally. Before medical school, she worked as a medical assistant and care coordinator across several specialties, including Family Medicine, Minimally Invasive Gynecologic Surgery (MIGS OB/GYN), Infectious Disease, and Breast Surgical Oncology. When she isn’t caring for patients on the wards or studying, she enjoys vlogging her medical journey, working out, spending time with friends and family, and mentoring aspiring minorities in medicine. She hopes to continue inspiring others by bridging her passion for storytelling, leadership, and advocacy in the pursuit of a more equitable future in healthcare.

Chelsea Oppong, MS, MS3

Chelsea Oppong is a third year medical student at St. George’s University School of Medicine. She earned her Master’s degree in Medical Physiology from Case Western Reserve University and her Bachelor of Science in Biology from Georgia State University. She served as Vice President of the Program for Adolescent Mothers (PAM) under the Women in Medicine chapter at St. George’s, where she developed and led initiatives to promote the health and well-being of adolescent mothers in Grenada. She also serves on the Gender Equity Task Force and the Sex and Gender Health Collaborative Committees within the American Medical Women’s Association. Beyond medicine, Chelsea is passionate about mentoring aspiring minority students and enjoys spending her free time with family and friends, exploring new experiences, or relaxing with a favorite reality show or classic sitcom.

Meghan Etsey, MS4

Meghan Etsey is a fourth year medical student from St. George’s University. She has a Bachelors of Arts in Biology and a Bachelors of Arts in Nutrition and Dietetics from Bluffton University in Bluffton, Ohio. She served as the President of the St. George’s University’s Women in Medicine chapter in St. George, Grenada where she expanded relationships with the community and worked towards educating women and helping the youth. She is also a member of the Gender Equity Task Force and Sex and Gender Health Collaborative Committees within the American Medical Women’s Association. When she is not pursuing medicine, you can find her with her friends and family on different road trips and adventures exploring the world. 

Teresa Lazar, MD MSEd is the clerkship director of the Advanced Clinical Experience in Obstetrics and Gynecology and Assistant Professor at the Donald and Barbara Zucker School of Medicine at Hofstra Northwell (ZSOM). She obtained her medical degree and completed her residency in obstetrics and gynecology from the State University of New York Health Science Center in Brooklyn and graduated with a Master of Science in Education degree in health professions from Hofstra University. Dr. Lazar was recognized with the APGO Excellence in Teaching Award and is a member of the Academy of Medical Educators and Alpha Omega Alpha Medical Honor Society at the ZSOM. Currently, a member of the American Medical Women’s Association Gender Equity Task Force and the Education Committee. Dr. Lazar is board certified by the American Board of Obstetrics and Gynecology, areas of clinical interest include general obstetrical care, gynecologic care and pelvic ultrasounds. Additionally, she is passionate about medical education, faculty development, communication, and leadership. She is fluent in both English and Spanish.