Until recently, misleading data from the original Women’s Health Initiative (WHI) hormone study clouded the view of menopause and hormone replacement therapies. Quite frankly, the study frightened a generation of women away from getting the help they deserved as they got older.
For the past two decades, medical professionals have been digging into that data, running additional studies, and recently published a new review in the Journal of the American Medical Association (JAMA). Today, with help from the medical community, women everywhere are starting to see hormone replacement therapy in a different light. That shift became official in November 2025, when the FDA began removing the black box warning—its strongest safety label—from hormone therapy products containing estrogen, and replacing them with the first updated product labels approved in early 2026.
Belmar Pharmacist, Rachel Noonan, PharmD, breaks down the JAMA review and the black box warning removal to help you make sense of the latest research on hormone therapy and menopause.
There’s a lot of information in this article. Can you explain the main point?
The biggest takeaway from this review is that 20 years of additional data has meaningfully shifted the clinical perspective of hormone therapy. The JAMA review highlights the benefits of hormone replacement therapy (HRT) for women under 60. This is a huge step forward in recognizing the value HRT can offer women navigating perimenopause and menopause symptoms.
What’s changed in the last two decades since the original Women’s Health Initiative (WHI) study?
Time has been the biggest factor. The JAMA review found that the chronic diseases flagged in the original WHI study were far less likely in younger populations than researchers had initially thought. Two decades of follow-up research gave the medical community the runway it needed to properly evaluate those early concerns. The picture that’s emerged is more nuanced and more reassuring than the original headlines suggested, especially for women closer to the start of menopause.
Did anything change on the regulatory side, too?
Yes. In November 2025, the FDA announced it was beginning to remove the black box warning—its strongest safety label—from hormone therapy products containing estrogen, citing outdated science behind the original 2003 warning. Specifically, the agency requested removal of warnings tied to breast cancer, cardiovascular disease, stroke, and probable dementia, along with the old instruction to use “the lowest effective dose for the shortest duration”; language that had discouraged longer-term use even in women who were good candidates.
The agency has since started approving updated labeling company by company. The first batch of six products across all major categories of hormone therapy got the green light in early 2026. It’s a meaningful shift: the same warning that helped scare a generation of women away from estrogen therapy is finally being rewritten to reflect what 20-plus years of follow-up data actually show.
Has the perception of menopause changed?
Menopause awareness has shifted in a big way. Women are speaking up about facing perimenopause without medical support, and after years of suffering in silence, they’re finding their voice. Topics that used to feel taboo are now front and center. This study is part of that bigger cultural shift toward taking quality of life seriously.
Less risk sounds promising. What about effectiveness? Are medical professionals still skeptical about the benefits?
I’d say skepticism has largely given way to renewed interest. The review authors noted that hormone therapy was established as an effective therapy for menopausal symptoms. This makes clear that the study was never meant to call that efficacy into question in the first place. It’s a welcome clarification and one that may make providers, including those in the functional medicine space, more open to having this conversation with their patients.
We also understand a lot more now about the differences between the hormones used in the WHI study and bioidentical hormones; a distinction the original study didn’t clearly draw. Bioidentical hormones are designed to closely mirror the hormones your body naturally produces. The hormones investigated in the WHI study, by contrast, were similar in effect but chemically altered from what the body makes on its own. It’s worth knowing the original WHI study didn’t investigate bioidentical hormones specifically.
What does this mean for me?
If you’re under 60 and dealing with hot flashes, night sweats, or other perimenopausal or menopausal symptoms, this research suggests hormone therapy may be a meaningful option worth exploring. Working with a hormone provider and a compounding pharmacy can help you find a bioidentical approach personalized to your symptoms and your labs. As with any therapy, your own health history and risk factors matter, so the right next step is bringing this research to your provider and talking through how it may be a fit for you.
What if my provider dismisses me or still doesn’t feel comfortable prescribing hormone therapies?
Here’s the study to share with your doctor. We offer clinical consultations for providers; we love growing that conversation across the medical community! If you’re looking for a provider experienced in bioidentical HRT, Belmar Pharmacy can help connect you with providers in your area who are engaged with this evolving research. Give us a call; our staff is happy to help point you in the right direction.
