PCW Clarity · Hormone therapy basics
Is menopause hormone therapy safe? What changed in 2025?
Maybe you stopped hormones in 2002. Maybe you never started because of the headlines. The guidance has moved.
The short answer
For many healthy women who start it before age 60 or within 10 years of menopause, current guidance says the benefits of hormone therapy usually outweigh the risks, but it's a personal decision with real risks to review. The Menopause Society's 2022 position statement calls hormone therapy the most effective treatment for hot flashes and night sweats. It says that for women under 60, or within 10 years of menopause onset, without reasons to avoid it, the benefit-risk ratio is favorable for treating those symptoms and for preventing bone loss. Risks are greater when it's started at older ages or further from menopause (NAMS 2022).
On November 10, 2025, the FDA asked makers of menopausal hormone therapy to remove boxed-warning language about cardiovascular disease, breast cancer and probable dementia. It kept the boxed warning about endometrial cancer for systemic estrogen-alone products, kept warning information about cardiovascular disease and breast cancer in the labels, and added that starting hormone therapy can be considered for moderate to severe hot flashes in women under 60 or within 10 years of menopause (FDA 2025). The Menopause Society agreed with removing the warning on low-dose vaginal estrogen and said systemic estrogen still carries potential risks to review in detail (The Menopause Society 2025).
Why does this matter?
- Many women were never offered it. The FDA noted that hormone therapy may be under-used among women likely to benefit (FDA 2025).
- The 2002 headlines came from an older group. The Women's Health Initiative enrolled women 50 to 79, with an average age of 63, older than most women starting therapy for hot flashes (FDA 2025).
- Long-term follow-up was reassuring on overall deaths. Over 18 years of cumulative follow-up, hormone therapy taken for 5 to 7 years in the WHI trials was not linked to higher risk of death from all causes (Manson 2017).
- It isn't for everything. It's not recommended just to prevent dementia (NAMS 2022), and it's not approved to treat or prevent diabetes, even though reviews found it may lower insulin resistance (Salpeter 2006).
- Local and systemic are different. Low-dose vaginal estrogen treats dryness, painful sex and some bladder symptoms, and The Menopause Society calls it safe and effective (NAMS 2020; The Menopause Society 2025).
How do I decide whether hormone therapy is worth discussing?
- Know your timing. How old were you at your last period, and how many years ago was it? Timing changes the benefit-risk picture (NAMS 2022).
- Name your symptoms and how much they cost you. Hot flashes, night sweats, sleep, painful sex, mood. Rate how much each affects work and life.
- Bring your personal and family history. Breast cancer, blood clots, stroke, heart disease and liver disease all matter. So do your preferences (The Menopause Society 2025).
- Ask about type and route. Systemic versus vaginal, and with or without a progestogen if you have a uterus. These are different conversations.
- Ask whether a product is FDA-approved. Compounded products don't go through the same approval and dose testing.
- Ask about testosterone carefully. A global consensus supports it only for low sexual desire with distress after menopause, not for energy, mood or muscle (Davis 2019).
Who on my care team handles what?
- A menopause-informed clinician reviews your history and decides whether hormone therapy fits. The Menopause Society has a practitioner finder.
- Your OB-GYN or primary care clinician handles screening, like mammograms, and ongoing follow-up.
- A pharmacist explains the product, the route and interactions with your other medicines.
- A mental health therapist when mood is part of why you're asking.
Where it breaks: a woman hears "no" without a real discussion, or "yes" without a review of her history. The fix is the same either way: a prepared visit with a clinician who treats menopause regularly.
How does the DAITT® Method connect to this?
DAITT® (say it like “date”) is our five-part way to look at a whole life. In wellness, the letters stand for Discipline of the body, Awareness, Intellect, Trust and Treasury. Here's how each one touches this question:
- Discipline of the body: Keep building the basics hormone therapy can't replace: strength, sleep, food.
- Awareness: Notice the fear from old headlines, and bring it into the room as a question.
- Intellect: Read the current guidance yourself. The 2022 statement and the 2025 FDA notice are linked below.
- Trust: Make the decision that fits your values and your history, and give yourself permission to revisit it.
- Treasury: Ask what your plan covers and what an FDA-approved option costs, before you're at the pharmacy counter.
Have you made a DAITT® with your future self? Take the free wellness DAITT® quiz on drpat.co. No forms, and nothing is saved.
Why does timing change the conversation?
Illustration
Two illustrations, not client stories. Lena is 52. Her last period was 2 years ago. She has 8 to 10 hot flashes a day and wakes most nights. She has no history of breast cancer, clots or stroke. Under current guidance, she's in the group where the benefit-risk ratio for treating hot flashes is generally favorable (NAMS 2022). Her clinician reviews her history, type and route, and follow-up.
Ruth is 68. Her last period was 18 years ago, and she asks whether hormones would protect her memory. That's a different conversation: she's further from menopause, where risks are greater, and hormone therapy isn't recommended to prevent dementia (NAMS 2022). Her clinician talks about other ways to support brain and bone health. Same medicine, very different questions.
What do the experts say, and where does the evidence land?
Dr. Mary Claire Haver (OB/GYN, in The New Menopause and on Huberman Lab) has been a leading public voice for updating hormone therapy guidance. Dr. Peter Attia's conversations with Dr. JoAnn Manson, a WHI investigator, and with urologist Dr. Rachel Rubin walk through the WHI and vaginal estrogen in depth. Those are expert commentary. The decision rules on this page come from The Menopause Society, the Endocrine Society, ACOG, the International Menopause Society and the FDA.
Related questions
What did the FDA change about hormone therapy in 2025?
On November 10, 2025, the FDA asked makers to remove boxed-warning language about cardiovascular disease, breast cancer and probable dementia, keep the endometrial cancer boxed warning for systemic estrogen-alone products, and add that starting therapy can be considered for moderate to severe hot flashes in women under 60 or within 10 years of menopause (FDA 2025).
Who is a good candidate for menopause hormone therapy?
The Menopause Society says that for women under 60 or within 10 years of menopause onset, without contraindications, the benefit-risk ratio is favorable for treating hot flashes and preventing bone loss (NAMS 2022). Your clinician decides based on your history.
Is vaginal estrogen safe?
The Menopause Society calls low-dose vaginal estrogen a safe and effective therapy for genitourinary symptoms of menopause and agreed with the FDA's decision to remove its boxed warning (The Menopause Society 2025).
Sources
Peer-reviewed research
- Manson JE et al. (2017). Menopausal Hormone Therapy and Long-term All-Cause and Cause-Specific Mortality: The Women's Health Initiative Randomized Trials. JAMA, 318:927-938.
- Salpeter SR et al. (2006). Meta-analysis: effect of hormone-replacement therapy on components of the metabolic syndrome in postmenopausal women. Diabetes Obes Metab, 8:538-54.
Medical societies and government
- The North American Menopause Society (now The Menopause Society) (2022). The 2022 hormone therapy position statement of The North American Menopause Society. Menopause, 29:767-794.
- The North American Menopause Society (now The Menopause Society) (2020). The 2020 genitourinary syndrome of menopause position statement of The North American Menopause Society. Menopause, 27:976-992.
- Davis SR et al. (2019). Global Consensus Position Statement on the Use of Testosterone Therapy for Women. J Clin Endocrinol Metab, 104:4660-4666.
- Stuenkel CA et al. (2015). Treatment of Symptoms of the Menopause: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab, 100:3975-4011.
- American College of Obstetricians and Gynecologists (ACOG) (2014). ACOG Practice Bulletin No. 141: management of menopausal symptoms. Obstet Gynecol, 123:202-216.
- Panay N et al. (2025). International Menopause Society (IMS) recommendations and key messages on women's midlife health and menopause. Climacteric, 28:634-656.
- U.S. Food and Drug Administration (2025). FDA Requests Labeling Changes Related to Safety Information to Clarify the Benefit/Risk Considerations for Menopausal Hormone Therapies.
- The Menopause Society (Nov 10, 2025). The Menopause Society Comments on the FDA Announcement on Hormone Therapy.
- The Menopause Society. Find a Menopause Practitioner.
Expert voices (commentary, not research)
- Dr. Mary Claire Haver (OB/GYN). The New Menopause (book, Rodale, 2024).
- Dr. Mary Claire Haver on Huberman Lab. How to Navigate Menopause & Perimenopause for Maximum Health & Vitality (podcast episode, June 2024).
- Dr. Peter Attia with Dr. JoAnn Manson, The Drive #253. Hormone replacement therapy and the Women's Health Initiative (podcast episode, May 2023).
- Dr. Peter Attia with Dr. Rachel Rubin, The Drive #348. Women's sexual health, menopause, and hormone replacement therapy (podcast episode, May 2025).
What's a good next step?
Start by learning, not buying. Read the short summary of this topic in the Women's Metabolic Clarity library at Pinnacle Coordinated Wellness, take the wellness DAITT® quiz, and bring the questions above to your clinician. If you'd like to see how a coordinated, done-with-you care team works, visit pinnaclecoordinatedwellness.com.
Read the library summaryTake the wellness DAITT® quiz
Questions to ask a licensed clinician
- Am I a candidate for hormone therapy, given my age and timing?
- What are my personal benefits and risks, given my history?
- Systemic or vaginal, and do I need a progestogen?
- Is this product FDA-approved?
- What do the 2022 Menopause Society statement and the 2025 FDA label changes mean for me?
- How will we follow up, and when would we revisit the decision?
Bring these, a short symptom log and your medication list to your next visit.
Who is Dr. Pat Pachciarz®?
Dr. Pat Pachciarz® is the founder of Pinnacle Coordinated Wellness and Founder & CEO of The Pinnacle Group in Aurora, Illinois. He is a Certified Personal Trainer and Certified Nutrition Coach through the National Academy of Sports Medicine. He's the guide and educator here, not a clinician: he teaches how to think about coordination and what to ask your licensed clinicians. More about Dr. Pat Pachciarz®.
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Also see Pinnacle Coordinated Wellness, drpat.co for the wealth and wellness crossover, and drpatclarity.com for family money questions.