Women have been warned loudly and often for more than 20 years that hormone therapy for menopause could be harmful. The FDA’s most serious warning label, printed in bold black, was on every pill, patch, cream, and vaginal tablet. It said, “This medicine raises your risk of breast cancer, stroke, heart disease, and dementia.”
That message changed everything. In the early 2000s, prescriptions fell by more than 70%, leaving millions of women to suffer in silence with hot flashes, insomnia, weight gain, bone loss, vaginal pain, and fatigue. This was all because fear took the place of nuance.
Things are finally changing now.
In July 2025, FDA Commissioner Dr. Martin Makary announced that the agency is preparing to remove or revise the black-box warning on hormone replacement therapy (HRT). The decision comes after an official panel of experts looked at the current label and said it was “outdated, inaccurate, and harmful.”
For the first time in decades, the FDA is admitting what women and researchers have been saying for years: the science has changed, and the warning is no longer accurate for hormone therapy today.
Quick Summary: Menopause Travel Tips for Women Over 50
- The FDA is preparing to revise or remove the black-box warning on menopause hormone therapy.
- The original warning stemmed from a 2002 study with flawed design, most participants were well past menopause.
- Newer research shows hormone therapy started earlier can reduce heart disease, fractures, and possibly dementia risk.
- Local and transdermal estrogen forms are safer and should not share the same warnings as oral forms.
- Experts urge the FDA to modernize labeling and fund more research to protect women’s health and informed choice.
The Study That Started the Hormone Therapy Scare
The Women’s Health Initiative (WHI) is where the story begins. It was a huge U.S. clinical trial that started in 1991 and was stopped in 2002 after early reports suggested that women taking estrogen plus progestin had higher risks of breast cancer, heart attack, and stroke. Those headlines triggered global panic.
But most people don’t know this: the study didn’t test the type of hormone therapy that most menopausal women actually use.
The average age of the participants was 63, which is about 10 years after menopause. Most of them were starting hormone therapy long after their bodies had gotten used to not having estrogen.
As Dr. JoAnn Manson, a principal investigator of the WHI and Chief of Preventive Medicine at Brigham and Women’s Hospital, later explained that WHI was testing the wrong population. Starting hormone therapy years after menopause may carry higher risks but for women who begin it near menopause, the data show benefits.”
The WHI told us what happens when women take hormones too late, not what happens when they start at the right time. The FDA, however, gave a broad black-box warning for all estrogen-containing products, no matter how much, how it was given, or when it was given.
That one choice changed how a whole generation thought about menopause care and left millions of women without treatment.
Why One-Size-Fits-All Warnings Don’t Work for Hormone Therapy
One of the biggest misunderstandings that the black-box warning made worse is the idea that all estrogen therapies have the same risks.
That isn’t true.
For example, low-dose vaginal estrogen is used to treat vaginal dryness, pain during sex, and urinary tract infections that keep coming back.
It works locally, not systemically, which means it doesn’t really get into the bloodstream. The WHI found that oral estrogen, which affects the whole body, was linked to the risks of stroke, blood clots, and cancer.
Still, both have the same warnings.
Dr. Rachel Rubin, a urologist and expert in sexual medicine, spoke to the FDA panel in July 2025:
“Local vaginal hormones are not only similar to, but actually way better than Viagra, because they help with sexual symptoms and prevent over 50% of urinary tract infections. We’ve known this for decades.” — Urology Times
But old-fashioned labels have scared off a lot of women. Even though doctors say that local estrogen is safe, many people still don’t want to get treatment because the FDA’s “scarlet letter” warning is so strong.
READ ALSO: Menopause and Estrogen: What Really Goes On With Your Hormones
What the Updated Science Shows
Science has completely changed how we think about menopause and hormone therapy in the 20 years since the WHI. Hormone therapy can be safe, not harmful, when used at the right time and in the right way.
New studies and reanalyses of WHI data show that the benefits of HRT often outweigh the risks for women who start it before age 60 or within 10 years of menopause.
Research shows:
- Reduced cardiovascular disease risk (American Heart Association)
- Lower fracture and osteoporosis risk.
- Better cognitive and mood outcomes.
- Improved quality of life and sexual health
- No significant increase in breast cancer risk for short-term use.
Dr. Manson now openly calls the black-box warning “really harmful,” saying that it has led to “tremendous undertreatment” of women’s symptoms.
Patches, gels, and creams that go through the skin, on the other hand, don’t go through the liver and have a lower risk of blood clots and strokes than oral pills. However, they are still labeled the same.
What the FDA Panel Did and Didn’t Do (Step by Step)
Here’s how we got here and what the change might (or might not) look like:
| Step | What Happened | Why It Matters |
|---|---|---|
| 1. FDA Expert Panel Convened (July 2025) | A 12-member panel met publicly to review evidence and debated whether the black-box warning on estrogen therapies should be removed or revised. | It’s a formal signal that regulators are rethinking labeling. |
| 2. Panel Recommendation | Panelists endorsed removing or modifying the black-box warning, especially for low-dose vaginal estrogen and asked for public comment. | While nonbinding, it paves the way for regulatory action. |
| 3. Public Comment Period | The FDA opened a docket (FDA-2025-N-2589) for public input until September 24, 2025. | Women and clinicians can voice support, concerns, or evidence. |
| 4. Labeling Decision Pending | The FDA has not yet committed to removing or altering the warning; any change will require evidence review, regulatory steps, and possibly further advisory committees. | This is not an instant change, expect deliberation. |
| 5. Clinical Practice Implications | If the black box is relaxed, doctors may feel more comfortable prescribing modern HRT methods, especially in lower-risk settings. | Could mean more options, clearer guidelines, more patient–doctor conversations. |
So although the panel’s recommendation is a breakthrough, nothing has legally changed yet.
What Removal of the Warning Would (and Wouldn’t) Do
Potential Upsides
- Less fear and stigma. The black box is scary and dramatic; changing it might make patients and providers less resistant.
- Better personalization. Without a general warning, doctors may feel more comfortable customizing treatments based on a person’s age, health, and risk.
- Focus on safer formulations. Low-dose vaginal estrogen, transdermal patches, and newer regimens may offer clearer differentiation from higher-risk oral therapies. Further research and updates are necessary
- More research and updates. The change could lead to new research and updated clinical guidelines.
- Improved access. Lower regulatory burden and less fear may increase prescriptions for women suffering symptoms.
What It Won’t Instantly Do
- Guarantee insurance or coverage changes. Regulatory labeling doesn’t always change what insurance companies will pay for.
- Change the standard of care overnight. Clinicians will move slowly, based on new guidelines and their own risk assessments.
- Remove the need for monitoring. Even safer plans should still be followed under the watchful eye of a doctor, with regular checks and reevaluations.
- Get rid of all risk. Hormone therapy still has risks, especially for some groups of people, like those with a history of breast cancer, blood clotting problems, uncontrolled high blood pressure, and so on.
What This Means for Women Over 50 Right Now
If the FDA follows through, this will be a big step forward for women’s health. But the message is clear even before the official change: you have options.
If you’re over 50 and going through menopause, here are some things you can do:
1. Gather baseline information
- Age, time since menopause onset
- Medical history: breast cancer, thrombosis, stroke, cardiovascular disease
- Family history, lifestyle factors (smoking, obesity, hypertension)
- Symptoms: hot flashes, night sweats, vaginal dryness, bone health, mood, sleep
- Current medications and risk factors
2. Have an informed conversation with your doctor
Ask if hormone therapy is right for you based on your age, how long it’s been since you had your last period, and your health history. Discuss both systemic and local options.
3. Understand your choices
- Local (vaginal) estrogen: Best treatment for dryness, pain, and urinary symptoms. It has almost no risk to the whole body.
- Transdermal estrogen: Patches or gels that give hormones through the skin and lower the risk of blood clots.
- Oral estrogen: Works well, but there is a small risk to the whole body, so use it with medical supervision.
| Therapy Type | Systemic or Local? | Typical Use | Risk Profile |
|---|---|---|---|
| Oral estrogen ± progestogen | Systemic | Classic HRT | Higher first-pass risk (clots, liver effects) |
| Transdermal patches/gel | Systemic | Moderate-severity symptoms | Bypasses first-pass, lower clot risk |
| Low-dose vaginal estrogen | Local (mostly) | Vaginal symptoms, urinary/genitourinary health | Very low systemic absorption; many experts view it as low-risk. |
| Newer non-hormone drugs (e.g. NK₃ antagonists) | Systemic | Hot flash relief alternative | E.g. fezolinetant carries rare liver warnings |
Choose the lowest effective dose and suitable route. Use the minimal dose that controls symptoms. Use safer routes when possible (vaginal or transdermal) to reduce systemic risk. Reassess the need periodically.
4. Consider your timing
The “timing hypothesis” suggests that starting hormone therapy closer to menopause (within ~10 years) may carry lower cardiovascular risk and possibly greater benefit. This means, if you’re under 60 or within 10 years of menopause, studies show that the benefits usually outweigh the risks. If you start later, you may need to keep a closer eye on things.
5. Monitor and reassess
- Annual breast exams, mammography per guidelines
- Monitor blood pressure, lipids, clotting family history
- Evaluate ongoing symptoms / side effects
- Re-evaluate continuing therapy after 3–5 years or more
6. Focus on holistic health
Hormones aren’t the only thing that affects how you feel during and after menopause. Your diet, exercise, sleep, stress management, and strength training all play a role.
7. Stay updated
Follow FDA announcements and The Menopause Society for updates on labeling changes and new research findings.
READ ALSO: How Long Does It Take For Hormone Replacement Therapy To Work Effectively?
How Estrogen Timing Could Be the Key to Protecting Your Brain After 50.
The link between estrogen and brain health is one of the most interesting new pieces of evidence.
Almost two-thirds of people with Alzheimer’s are women. Experts thought it was because women live longer for many years. But new research shows a different picture: the big drop in estrogen during menopause may speed up brain aging and make people more likely to get dementia.
Estrogen helps keep blood flow steady, protects neurons, and controls brain metabolism. Those protective systems get weaker when it falls.
Weill Cornell Medicine did a meta-analysis in 2023 that looked at data from more than 6 million women across 51 studies, found that those who started estrogen therapy during midlife had a 32% lower risk of dementia. Women who started HRT after age 65, on the other hand, did not see any benefits and sometimes even harm.
The “critical window hypothesis” says that estrogen therapy works best when it starts during the menopausal transition or soon after, not years later.
Recent research published in Science Advances adds another layer: estrogen therapy seems to slow down the buildup of tau proteins, which are a sign of Alzheimer’s disease, in brain areas that are most likely to be affected by menopause.
Researchers like Dr. Lisa Mosconi, who runs the Alzheimer’s Prevention Program at Weill Cornell, are now running trials to see if starting hormone therapy earlier can stop cognitive decline altogether.
READ ALSO: Brain Health Breakthrough: Boost Your BDNF Levels to Stay Sharp and Youthful
Final Thoughts & What You Can Do
This changing movement by the FDA panel gives hope to women over 50 who have been stuck between painful symptoms and a constant fear of hormone therapy. But it’s not a magic fix; it’s a turning point toward more balanced, modern, evidence-based care.
If you’re in your 50s or older and have menopausal symptoms:
- Keep up with what’s going on with the FDA.
- Get your health information, such as your history, lab results, and the number of symptoms you have.
- See a gynecologist, endocrinologist, or women’s health specialist who knows about menopause.
- Ask specific questions about the formulation, dose, monitoring, and length of time.
- If the FDA is still taking comments or holding public meetings, make sure your voice is heard.
- Over time, keep thinking about the choices you’ve made about your treatment.
You should feel safe, respected, and empowered, not scared. While we wait for regulations to change, we can take charge of our own bodies by learning about the details, weighing the pros and cons, and being involved in decisions about our health.
FAQs on FDA Re-Evaluating Hormone Therapy Risks
Not yet. The panel’s recommendation is persuasive but nonbinding. The FDA must review comments, additional evidence, and regulatory processes before making changes.
No. Risks still exist (breast cancer, clotting, stroke, etc.), especially in high doses or high-risk women. The goal is better nuance, not removal of caution.
Many experts believe low-dose vaginal estrogen was unfairly lumped under the black box. The push particularly targets revising or removing the warning for these local therapies because systemic absorption is minimal.
Generally yes, especially regarding clotting risk, because it avoids the liver “first-pass” effect.
Not necessarily. Many women in their early 50s or even late 50s respond well to carefully selected regimens. But the further from menopause you are, the more cautious assessment is needed (timing hypothesis).
The FDA invited public comment via docket FDA-2025-N-2589 (deadline Sept 24, 2025) on risks/benefits of hormone therapy. You can submit your story, clinical evidence, or perspectives via Regulations.gov.
References
American Heart Association. (2023). Menopausal hormone therapy and cardiovascular disease: A scientific statement from the American Heart Association. Circulation, 147(e621–e644). https://www.ahajournals.org/doi/10.1161/CIR.0000000000000912
NeuroAthletics. (2025, October 3). Breaking news: FDA preparing to remove the black box warning on hormone replacement therapy for menopause. NeuroAthletics Substack. https://neuroathletics.substack.com/p/breaking-news-fda-preparing-to-remove
Axios. (2025, July 18). FDA panel pushes to remove menopause hormone therapy warning. Axios. https://www.axios.com/2025/07/18/fda-menopause-hormone-therapy
Contemporary OB/GYN. (2024). Experts urge FDA to revise boxed warnings on hormone therapies for menopause.https://www.contemporaryobgyn.net/view/experts-urge-fda-to-revise-boxed-warnings-on-hormone-therapies-for-menopause
Harvard Health Publishing. (n.d.). Menopausal hormone therapy: Benefits and risks. Harvard Medical School. https://www.health.harvard.edu/womens-health/menopausal-hormone-therapy-benefits-and-risks
Manson, J. E., Chlebowski, R. T., Stefanick, M. L., Aragaki, A. K., Rossouw, J. E., Prentice, R. L., Anderson, G., Howard, B. V., Thomson, C. A., LaCroix, A. Z., Wactawski-Wende, J., Jackson, R. D., Limacher, M., Margolis, K. L., Wassertheil-Smoller, S., Beresford, S. A. A., Cauley, J. A., & Hsia, J. (2013). Menopausal hormone therapy and health outcomes during the intervention and extended poststopping phases of the Women’s Health Initiative randomized trials. JAMA, 310(13), 1353–1368. https://pubmed.ncbi.nlm.nih.gov/24084921/
National Library of Medicine. (2018). Menopausal hormone therapy and its timing: The critical window hypothesis.PubMed. https://pmc.ncbi.nlm.nih.gov/articles/PMC3780981/
Peter Attia, M. D. (2024, March 12). It’s time to remove warning labels on hormone replacement products.https://peterattiamd.com/its-time-to-remove-warning-labels-on-hormone-replacement-products
Science Advances. (2024). Hormone therapy and tau pathology in women’s brains. Science Advances, 10(15), eadm6789. https://www.science.org/doi/10.1126/sciadv.adt1288
The Menopause Society. (2023). The 2023 hormone therapy position statement of The Menopause Society. https://www.menopause.org/docs/default-source/professional/practice/hormone-therapy-position-statement.pdf
Urology Times. (2024, April 8). Ashley Winter, M.D., calls for label update on low-dose vaginal estrogen. https://www.urologytimes.com/view/ashley-winter-md-calls-for-label-update-on-low-dose-vaginal-estrogen
U.S. Food and Drug Administration. (2025, July 17). FDA expert panel: Menopause and hormone replacement therapy for women. https://www.fda.gov/patients/fda-expert-panels/fda-expert-panel-menopause-and-hormone-replacement-therapy-women-07172025
Weill Cornell Medicine. (2023, October 6). Estrogen therapy in midlife may lower dementia risk.https://news.weill.cornell.edu/news/2023/10/estrogen-therapy-in-midlife-may-lower-dementia-risk
