For more than three decades, I’ve worked alongside women navigating the complex and often overlooked terrain of perimenopause and menopause. I’ve witnessed the life-altering improvements that hormone therapy can bring – clearer thinking, better sleep, stronger bones, restored sexual health, and a renewed sense of vitality. But I’ve also watched, with no small measure of frustration, as countless women were denied these benefits due to a single, outdated obstacle: the FDA’s black box warning on estrogen therapy.
Today, I’m heartened to see the FDA finally reevaluating this position.
A Longstanding Misstep
The origin of this issue dates back to 2002, when the Women’s Health Initiative (WHI) study sent shockwaves through the medical community. The media seized on reports that hormone replacement therapy, particularly the combination of conjugated equine estrogen and synthetic progestin, might increase the risk of breast cancer, heart disease, stroke, and dementia.
But many issues were lost in translation of the WHI study. For example, and what many women were never told, is that the average participant in the WHI study was 63 years old, well beyond the window where hormone therapy is most beneficial. The majority had already been postmenopausal for more than a decade. We now know this matters immensely. Starting systemic hormone therapy within 10 years of menopause onset, and ideally before age 60, appears to reduce cardiovascular risk, preserve cognitive function, and support healthy bone metabolism.
More obfuscating was the use of an oral estrogen called Premarin, derived from pregnant mare’s urine (hence the name PREgnant MARes urINe). It contains a mixture of 10 estrogenic compounds, primarily sulfate conjugates of estrogens, including both human and equine estrogens. Only 2 of the 10 are found in humans and the most prevalent in Premarin is estrone which is known to be a more carcinogenic estrogen than other naturally occurring estrogens such as estriol. High levels given orally are also well known to induce blood clots.
The other drug used in the WHI is a synthetic “look alike” to our natural progesterone, called medroxyprogesterone acetate or brand name Provera. Though they are both “progestins” (compounds that activate progesterone receptors), they are not biologically identical and have different pharmacologic effects, especially on the breast, brain, cardiovascular system, and clotting pathways. Provera is well known to increase the risk of breast cancer, blood clots, and heart attacks, while progesterone does not.
The final “coup de grace” for women was the lack of complete reporting of the results, which showed over 95% of the women in the study had no adverse events, yet had significant relief of many menopausal symptoms. Furthermore, there was no significant difference in overall mortality between the Premarin-Provera treatment group and placebo group over long-term follow-up. The Premarin only treatment group of the study actually had a decreased overall mortality as well as decreased risk of breast cancer!
Despite these nuances, the FDA issued a sweeping black box warning on all estrogen products. That label, intended to highlight serious or life-threatening risks, has for years applied indiscriminately to oral, transdermal, and even low-dose vaginal estrogen products, regardless of dose, delivery method, or age of the patient. The result? Millions of women were discouraged from using safe and effective treatments for symptoms that severely affect their quality of life.
The Real-World Impact
In my practice, I’ve met countless women who were suffering, physically and emotionally, from night sweats, sexual pain, low libido, insomnia, brain fog or depression. Many had tried every over-the-counter solution available. When I suggested hormone therapy, they would look at me with a mixture of hope and fear. “Isn’t that dangerous?” they’d ask. “My doctor said I could get cancer.”
Equally distressing are the women who have presented to me with conditions related to hormone deficiency such as osteoporosis, heart disease, urinary incontinence, weight gain, insulin resistance and loss of muscle mass. Despite otherwise good health habits many women develop these conditions as a result of low hormones.
It’s not their fault. That’s what the black box warning implies. And for too long, too many clinicians have clung to the outdated WHI interpretation, leaving women underinformed and underserved.
But science has moved on. Numerous follow-up studies and re-analyses, alongside clinical experience, have shown that transdermal estradiol, micronized progesterone, and vaginal estrogen products are far safer than once thought, especially when tailored to the individual.
A Needed Shift in Policy
That’s why the recent decision by the FDA to reassess its stance on hormone therapy is so significant. On July 17, 2025, a panel of independent experts convened to review current evidence on menopausal hormone therapy. They unanimously agreed that low-dose vaginal estrogen products, which are often used to treat vaginal dryness, recurrent UTIs, and painful intercourse, should no longer carry a black box warning. The reasoning is simple: these formulations exhibit negligible systemic absorption and have no meaningful impact on breast cancer or cardiovascular risk.
This alone is a long-overdue victory for women, particularly those experiencing genitourinary syndrome of menopause, a condition that affects more than 40% of postmenopausal women but is treated in only a fraction of them.
Even more promising, the FDA is now accepting public comments and exploring more nuanced labeling for systemic hormone therapy, including bioidentical estradiol and progesterone, based on age, health status, and delivery method. If they follow through, this could represent a sea change in how we care for women during midlife and beyond.
Bioidentical Hormones: A Safer, Smarter Choice
As someone who has prescribed bioidentical hormones for decades, I’ve always believed in individualized, physiologic dosing, delivered in the right form, at the right time. Bioidentical estradiol, whether in patch, gel, or lozenge form, mirrors the hormone a woman’s body naturally produces. Likewise, micronized progesterone, when taken orally or transdermally, does not carry the same risks associated with synthetic progestins like medroxyprogesterone acetate.
When initiated early in the menopausal transition and monitored appropriately, these therapies are not only effective but also remarkably safe. Indeed, the North American Menopause Society (NAMS), the Endocrine Society, and even the American College of Obstetricians and Gynecologists (ACOG) have acknowledged that the benefits of HRT outweigh the risks for many women, especially when started early.
The Road Ahead
I applaud the FDA’s willingness to revisit and revise its warnings. But this must be more than a symbolic gesture. The black box warning has been a psychological and clinical barrier for over 20 years. If we are to truly empower women, we need labeling that reflects the latest science, not fear-based generalizations.
We also need a renewed focus on clinician education. Many primary care providers and even some OB/GYNs still operate under the shadow of the WHI headlines. They’ve been taught to fear estrogen, to minimize its use, or to offer it only as a last resort. But hormone therapy should not be a last resort, it should be a first-line option when appropriate.
Most of all, we need to give women back their agency. Too many have been told to suffer in silence. Too many have been offered antidepressants instead of hormones. Too many have been told their symptoms are “just part of aging.” That era needs to end.
Final Thoughts
I’ve seen firsthand the transformation that hormone therapy can bring. I’ve watched women regain their strength, confidence, and joy. And I’ve also watched them wrestle with unnecessary fear because of a warning label that never should have applied to them.
This FDA reassessment is more than a regulatory update, it’s a validation of the lived experience of millions of women and a recognition that one-size-fits-all medicine doesn’t serve anyone well.
Let’s hope this marks the beginning of a new chapter, one where menopause is met not with fear, but with informed, compassionate, and individualized care.
Author
Scott Rollins, MD, is Board Certified with the American Board of Family Practice and the American Board of Anti-Aging and Regenerative Medicine. He specializes in bioidentical hormone replacement for men and women, thyroid and adrenal disorders, fibromyalgia and other complex medical conditions. He is founder and medical director of the Integrative Medicine Center of Western Colorado (www.imcwc.com) and Bellezza Laser Aesthetics (www.bellezzalaser.com). Call (970) 245-6911 for an appointment or more information.
