For more than two decades, women have been told to approach hormone therapy with caution — or, in some cases, to avoid it altogether. That’s largely because of a scary-looking “black box” warning slapped on estrogen products back in 2003, linking them to risks like breast cancer and heart disease.
Now, the FDA has finally acknowledged what many menopause experts have been saying for years: those warnings were overblown.
So what does this shift actually mean for women deciding whether to start — or stick with — hormone therapy? We asked one of our favorite women’s health experts, Rebecca Brightman, MD, some of the questions that might be on your mind right now.
With the new changes in how the Food and Drug Administration is treating hormone-therapy warnings, how might this affect routine decisions about starting or continuing hormone therapy during menopause?
I think women will feel less fearful when menopause hormone therapy (MHT) is recommended. Just as importantly, I hope this change helps healthcare providers feel more confident and comfortable prescribing hormones to treat bothersome menopausal symptoms — whether that’s local vaginal estrogen for genitourinary syndrome of menopause (GSM) or systemic MHT.
For someone around perimenopause or early menopause, what should be the main considerations now, when choosing whether or not to use hormone therapy?
The first step is finding a healthcare provider who’s experienced in guiding women through the menopause transition. The main goals should be to optimize overall health, evaluate cardiovascular and cancer risks, and maintain a healthy lifestyle with good nutrition and regular exercise. It’s also important to have a thorough cancer risk assessment and to understand whether you’re a good candidate for hormone therapy in the first place.
Does this new guidance change how you look at risks like heart disease, bone health or memory issues when recommending hormone therapy?
I already feel very comfortable caring for women in midlife and beyond and have long been confident recommending MHT. So the removal of the boxed warning won’t change how I prescribe it. The bigger impact, I think, is that more women will feel comfortable considering MHT, and more providers will feel confident prescribing it.
Here’s what we know: Women who go through menopause early — before age 45 — or have primary ovarian insufficiency (POI, previously called premature menopause) clearly gain cardiovascular and bone protection when MHT is started. There’s also some evidence that this group may get a bit of cognitive benefit.
For women who reach menopause at the average age (around 51.5 years), MHT may offer modest cardiovascular benefits, but it shouldn’t be used as first-line therapy for that purpose — and definitely not in place of a statin. I’ve always recommended MHT for bone protection and to help prevent osteopenia or osteoporosis, and I think more women will now be open to it for that reason.
As for cognitive decline: despite what you might see on social media, there’s no evidence showing that MHT prevents memory loss in women who experience natural menopause. However, if night sweats are disrupting sleep, improving those symptoms can lead to better rest, clearer thinking, and less brain fog.
What types of hormone treatments (patches, pills, creams) are more or less favorable, in light of these label‐changes and what questions should I ask my doctor about them?
A woman’s health history, lifestyle, and cancer risk factors usually determine which option makes the most sense for her. Managing menopause isn’t one-size-fits-all — it’s very individualized and nuanced. The best approach comes from an open, shared conversation that weighs all of these factors. I always encourage patients to stay flexible and keep an open mind, since finding the right treatment can take some trial and error.
Are there different monitoring or follow-up strategies we should now be using (for example: checkups, labs, imaging) because the risk-benefit balance may be shifting?
In addition to reviewing cardiovascular and cancer risks, all women should stay up to date with standard screenings for breast, colon, and cervical cancer. Before starting hormone therapy, I recommend a baseline bone density scan.
When using FDA-approved hormones to treat menopausal symptoms or GSM, checking hormone levels isn’t standard practice. That said, if someone is on a typical dose and still has symptoms, measuring hormone levels can be useful in certain cases.
Menopause care is very individualized — it’s not a one-size-fits-all approach, and there’s no specific “target” hormone level, like there is with thyroid disease. What is essential, though, is that women with an intact uterus get adequate endometrial protection with a progestogen. The type and dose depend on the form and amount of estrogen being used.
Finally, I only continue prescribing hormone therapy if patients are keeping up with their health screenings and follow-up care.
