For 20 years, women were told to fear hormones. The FDA just changed course.

YOUR HEALTH — Issue No. 19

Hormones After 50 — Part 1: Women

For as long as I have been practicing medicine, menopause and the symptoms that come with it have been a difficult subject.

Part of that difficulty was clinical — hormones are complex and individual responses vary. But a larger part was something else entirely. We were trained to be cautious about hormone replacement therapy. Cautious because of what we were told it could do — increase the risk of breast cancer, cardiovascular disease, even dementia. As a result, women were urged not to take HRT despite symptoms that genuinely affected their quality of life. They were asked to suffer. Some were prescribed antidepressants in an attempt to manage what was ultimately a hormonal problem.

The FDA had its strictest safety designation — a black box warning — attached to these medications. A black box warning is another way of saying there is a possibility of serious or life-threatening risks. And for most providers, hot flashes and sleep disruption did not feel like sufficient justification to prescribe a medication carrying the FDA's most serious safety label. The perceived risk of breast cancer outweighed the benefit of symptom relief. So we avoided it. We found other ways to manage symptoms. And an entire generation of women suffered through menopause unnecessarily.

In November 2025, the FDA began removing those warnings. By February 2026, the first six hormone therapy products had updated FDA-approved labeling.

So what happened? Did we get menopause wrong?

Not exactly. But we may have gotten the evidence wrong — and then spent two decades treating millions of women as though the mistake applied to everyone.

What menopause actually does — the short version

Menopause isn't just a missed period.

As the ovaries produce less estrogen and progesterone, the effects can be felt throughout the body — hot flashes, night sweats, disrupted sleep, vaginal symptoms, changes in mood and sexual function, and accelerated bone loss.

For some women it is barely noticeable. For others it can completely change how they feel and function.

That matters — because for a long time the medical conversation focused heavily on the risks of treating those symptoms, and much less on the consequences of leaving them untreated.

The WHI study — and what medicine did with it

In 2002, the Women's Health Initiative published results that appeared to show hormone replacement therapy increased the risk of breast cancer, cardiovascular disease, stroke, and dementia. Within months, HRT prescriptions collapsed. Providers stopped prescribing. Women stopped asking. The black box warning was applied.

The problem wasn't that the WHI study was useless. The problem was what medicine did with it.

The women enrolled in the study averaged 63 years old. Two thirds were older than 59. Most were more than a decade past menopause — not recently menopausal women in their early 50s experiencing active symptoms. Many had pre-existing cardiovascular risk.

The results from specific hormone regimens studied in an older population were ultimately treated as though they applied equally to every hormone preparation, every woman, and every stage of menopause.

The Endocrine Society has concluded that data from the WHI studies cannot be appropriately applied to calculate risks and benefits of hormone therapy in women starting shortly after menopause.

That misapplication — not the study itself — is the medical error.

What a closer look at the data revealed

In the years that followed, researchers began looking more carefully at the data. What emerged changed the clinical picture significantly.

Hormone therapy initiated within 10 years of menopause — in women under 60 — shows a meaningfully different risk-benefit profile than what the WHI suggested. The timing of when therapy is started matters enormously.

On breast cancer specifically — the data told a story that directly contradicted what most women and providers believed. Estrogen-alone therapy in women without a uterus was actually associated with a lower risk of breast cancer and all-cause mortality in the long term.

The combined estrogen plus progestin formulation — the combination used in the original WHI — does carry a small increased breast cancer risk with long-term use. The type of progestin matters. Natural micronized progesterone appears to carry lower risk than the synthetic version used in the WHI.

One important note for women with an intact uterus: progestin is not optional. Estrogen alone stimulates the uterine lining — without progestin to balance it, endometrial cancer risk rises significantly. The question is not whether to take a progestin — it is which one.

Dr. Stephanie Faubion, medical director of the North American Menopause Society, has stated that the WHI results were misinterpreted for years, and an entire generation of women was denied effective treatment because of fear.

In November 2025, FDA Commissioner Marty Makary stated: "Tragically, tens of millions of women have been denied the life-changing and long-term health benefits of hormone replacement therapy because of a medical dogma rooted in a distortion of risk." The FDA removed references to cardiovascular disease, breast cancer, and probable dementia from the boxed warning, while retaining those risks elsewhere in the prescribing information. By February 2026, the first six hormone therapy products had updated FDA-approved labeling.

Who this applies to — and who it doesn't

The updated evidence is most relevant for women within 10 years of menopause onset — generally under age 60 — with symptoms that are meaningfully affecting their quality of life.

For women more than 10 years past menopause or over 65 — the risk-benefit calculation is less favorable. Starting hormone therapy new at 70 is a different clinical situation than continuing it in a woman who began before 60.

For women well beyond the usual menopause transition — particularly those over 65 or 70 — starting systemic hormone therapy for the first time requires a much more individualized risk-benefit discussion.

Low-dose vaginal estrogen is a different conversation. Because systemic absorption is much lower than with systemic hormone therapy, it is generally considered a safer option for treating genitourinary symptoms — including in many older women.

A word on route of delivery:

Transdermal estrogen — patches and gels — does not carry the same blood clot and stroke risk as oral estrogen. Oral estrogen is processed through the liver and increases clotting factors. Transdermal bypasses that process. For women with cardiovascular or clotting risk factors, the choice between oral and transdermal estrogen is an important part of the clinical conversation.

The conversation worth having

The lesson from the last 23 years is not that every woman should take hormone therapy.

The lesson is that women deserve a conversation based on the evidence we have today — not the fear that followed a study published in 2002.

If you are experiencing symptoms that are affecting your quality of life, you do not need to decide whether HRT is right for you before you see your provider. You just need to know that it is reasonable to ask.

"Could hormone therapy be appropriate for me?"

Twenty years ago that question was often met with fear. Today it deserves a more nuanced answer. Your provider — armed with the 2025 label changes — should welcome it.

Specific questions worth bringing:

"Am I within the 10-year window where hormone therapy has a favorable risk-benefit profile?"

"Would transdermal estrogen be appropriate for me given my history?"

"If I still have my uterus — what type of progesterone would you recommend and why?"

Something worth saying plainly:

The question isn't "Should women take hormones?"

It is "For which women do the benefits outweigh the risks?"

That is a much better question. And after two decades of fear, it is good to be asking it again.

The FDA didn't declare hormone therapy safe for everyone. It acknowledged that the old warning didn't tell the whole story — and that women and clinicians deserved more accurate information to make that decision.

That conversation is open again. If it applies to you — have it.

The Member deep-dive this week covers the five variables that actually change the hormone therapy decision — which estrogen, which progestin, oral versus transdermal, FDA-approved versus compounded, and what the breast cancer evidence actually says. Plus testosterone in women — the hormone most often left out of the conversation."

Next week: Hormones After 50 — Part 2. Testosterone in men — what actually changes, what the data shows, and who actually needs treatment.

Plain Medicine is published for educational purposes only and does not constitute medical advice or establish a patient-provider relationship. Always consult your healthcare provider before making medical decisions.

— Kyle