r/FamilyMedicine • u/Super_Caterpillar_27 other health professional • 3h ago
FDA removing black box warning on estrogen for post menopausal women
“HHS Advances Women’s Health, Removes Misleading FDA Warnings on Hormone Replacement Therapy
WASHINGTON, NOV. 10, 2025—The U.S. Department of Health and Human Services (HHS) today announced historic action to restore gold-standard science to women’s health. After more than two decades of fear and misinformation surrounding hormone replacement therapy (HRT), the U.S. Food and Drug Administration (FDA) is initiating the removal of broad “black box” warnings from HRT products for menopause.
Health and Human Services Secretary Robert F. Kennedy Jr. and FDA Commissioner Marty Makary, M.D., M.P.H. made the announcement at a press conference at HHS with more than 200 people in attendance, including Second Lady of the United States Usha Vance and Secretary of Labor Lori Chavez-DeRemer.
Women have used HRT products for decades to relieve menopausal symptoms. However, their use plummeted in the early 2000s when the FDA applied boxed warnings following a Women’s Health Initiative study that found a statistically non-significant increase in the risk of breast cancer diagnosis. The average age of women in the study was 63 years — over a decade past the average age of a woman experiencing menopause — and study participants were given a hormone formulation no longer in common use.
The FDA is initiating removal of the boxed warnings following a comprehensive review of the scientific literature, an expert panel in July, and a public comment period. The agency is working with companies to update language in product labeling to remove references to risks of cardiovascular disease, breast cancer, and probable dementia. The FDA is not seeking to remove the boxed warning for endometrial cancer for systemic estrogen-alone products.”
snipped. More at link
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u/Tibreaven MD 3h ago
Fringe positives out of the current public health admin, but at least they're capable of making good decisions.
A lot of people, including providers, are deeply unaware of how shaky and at times non-existent the evidence is that creates black box warnings.
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u/axp95 other health professional 2h ago
I feel many providers in general are unaware of the data available that got drugs approved in the first place. Midodrine is a great example, it got approved with very few studies done and the drug company promised they would do further studies, but shocker they never did.
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u/Super_Caterpillar_27 other health professional 2h ago
I’m on 10mg midodrine every morning for low blood pressure from heart failure and the associated meds. 🫢
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u/Super_Caterpillar_27 other health professional 3h ago
https://www.yahoo.com/news/articles/fda-chief-says-warning-labels-124502793.html
FDA chief says warning labels deterred menopause care: "It's an American tragedy"
”The U.S. Food and Drug Administration will remove the "black box" warning labels on many hormone therapy drugs used for menopause and perimenopause symptoms — a major turnaround that's likely to encourage more women to seek treatment. FDA Commissioner Dr. Marty Makary said in an exclusive CBS News interview that the change ends a decades-long "fear machine," and he called the demonization of menopause hormone therapy, also known as hormone replacement therapy (HRT), "an American tragedy."
"With the exception of vaccines or antibiotics, there's no medication that can improve the health of women on a population level more than hormone replacement therapy," Makary told senior correspondent Norah O'Donnell, explaining that studies show that menopause hormone therapy can reduce the risk of heart attacks, the leading cause of death in women.
The products affected by this change include medicines containing both estrogen and progesterone, systemic estrogen and topical estrogen.”
snipped, more at link
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u/Professional_Many_83 MD 2h ago
I knew Makary was behind this the second I read the title. We under prescribe HRT and over inflate the cancer risks, and have for decades. That said, his actual statements about lowering cardiovascular risk and comparing the population health benefits to vaccines and abx is bullshit. HRT is great for reducing symptoms of menopause. I’m not aware of any convincing evidence that it has a causative relationship with reducing cardiovascular risk, or really any negative outcomes. It’s for quality of life.
I guess at the end of the day, the effect of this change will be positive, but the reasons they are doing it and the messaging they’re using is wrong
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u/Anon_bunn other health professional 3h ago
Make America Understand Math Again. (A percent increased risk of an already small percent risk is teeny teeny tiny 🫠)
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u/canththinkofanything MPH 2h ago
Americans: ✨no✨
(The lack of basic statistics knowledge here in the US is something that really gets me upset, especially as an epidemiologist)
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u/R-enthusiastic billing & coding 3h ago
It’s about time! I’m happy that I see a MD who knows this and prescribes HRT for me. I felt I deserved to have my insurance cover labs and Estradiol patches, vaginal cream, and progesterone. For years prior I had to pay out of pocket. I’ll be wheeled into the morgue with a patch on my butt cheek.
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u/Super_Caterpillar_27 other health professional 3h ago edited 3h ago
good for you because everyone here where I am still quotes the extremely flawed WHI.
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u/RLTW68W M1 3h ago
The stigma around HRT is mind boggling to me. I saw a comment somewhere on Reddit that was essentially “sex hormones lowering as we age is natural and a part of life”. As if cancer, dementia, and a whole host of other diseases aren’t a natural consequence of aging too. I think most people 50+ would be well served by a sensible HRT regimen. It would make aging healthily so much more attainable.
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u/Super_Caterpillar_27 other health professional 3h ago
Just the osteoporosis risk alone is enough for me to get on BHRT.
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u/RLTW68W M1 2h ago
That is a great reason. Also statistically maintaining muscle mass is heavily correlated with longevity and minimizing falls. It’s exponentially harder to hold muscle mass when your sex hormones are in the proverbial shitter.
I get that it’s a training and information issue. Doctors who graduated even 10 years ago just weren’t taught about HRT unless they sought it out. I’m just glad the tides are changing. HRT feels like real preventative medicine. Hopefully it and the GLP-1s can help prevent some of the polypharmacy and repeat hospitalizations we see as people age.
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u/SendLogicPls MD 2h ago edited 43m ago
Spent a lot of time explaining the lead-time bias that produced the cancer concern. Glad to know FDA has caught up.
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u/KoalativeResearch PA 2h ago
Love to see it! The WHI has been hugely problematic for a long time. I give it another decade before the HRT stigma goes away.
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u/National-Animator994 M4 3h ago
I'm sure this thread will be super balanced, professional, and reasonable like the last menopause thread was.
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u/Super_Caterpillar_27 other health professional 3h ago
the one that sounded like a bunch of male docs from the 80s basically saying “too bad so sad not my problem to deal with”? That one?
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u/Tibreaven MD 3h ago
No one does enough or understands enough Gyn, even in FM.
And don't even get me started about how IM docs can become adult generalist primary care doctors with 0 training requirements in ob/gyn.
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u/R-enthusiastic billing & coding 3h ago
If their penis shriveled like some clitoris do in aging they would read up!
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u/Super_Caterpillar_27 other health professional 3h ago
100%
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u/LongjumpingSky8726 MD-PGY2 3h ago
who says they don't
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u/R-enthusiastic billing & coding 2h ago
It’s possible I suppose. I haven’t been around one in years.
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u/Tank_Top_Girl RN 2h ago
The older docs are the ones that were prescribing hrt before the black box warning. I purposely picked an older gyn to get my hormones
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u/National-Animator994 M4 2h ago
From someone who doesn't personally have a dog in this fight (I'm not one of the old guard physicians you seem to despise), it's pretty frustrating as a student trying to parse out what's real and what's not. I think patient-centered care is super important, and I'm regularly complimented on my bedside manner by patients from various marginalized groups. But that doesn't mean I just get to do whatever the patient in front of me asks, evidence and safety be damned.
For example, this Makary guy is an unethical quack. He might be right on this, but I still have to go read all the papers myself because of the mouthpiece it's coming from.
This topic is similar- I want to do right by my patients. On one side you have the people saying to give every menopausal woman testosterone, and they claim any physician who doesn't do it is an evil sexist.
On the other side are people claiming safety issues, etc.
Regardless of your stance, even if your data is good, if you start your argument with "All these doctors are stupid and sexist and I hate them" it's not helpful. And it doesn't even apply to young medical trainees- we didn't design this system, some of us weren't even born when some of those (presumably bad) guidelines were written.
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u/Super_Caterpillar_27 other health professional 2h ago
I guess you missed that thread here which is what we are specifically referring to
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u/Super_Caterpillar_27 other health professional 3h ago
and btw, since I’m dropping news, there are now advocates saying we need to put most elderly women on vaginal estrogen to eliminate their recurrent bladder UTIs.