On July 17, 2025, the FDA convened a panel of experts to reevaluate the role of estrogen in menopausal hormone therapy (MHT). Physicians and researchers gathered to discuss the latest evidence around the safety and efficacy of estrogen therapy—especially in light of long-standing concerns that have shaped treatment decisions for over two decades.
One possible—and long overdue—outcome of this meeting? The removal of the black box warning on estrogen products. If this happens, it could pave the way for more women to access appropriate, evidence-based care.
What Is a Black Box Warning?
A black box warning is the FDA’s strongest type of alert. It appears as a bold black border around a serious warning in the prescribing information, designed to alert healthcare providers and patients to major risks associated with a medication.
Estrogen products have carried this warning since 2003, following the release of the Women’s Health Initiative (WHI) data. The initial interpretation of the WHI raised alarms about a possible increase in breast cancer, cardiovascular disease, and stroke in women using hormone therapy. The response was swift and cautious: doctors were advised to prescribe the lowest dose for the shortest duration possible—or avoid estrogen altogether.
Reexamining the Evidence
In the years since, follow-up analyses have called those early conclusions into question. The original WHI trial had significant limitations, including the age and health status of the participants. Many of the women studied were over 60 and well past the onset of menopause, a group for whom risks may differ significantly from women who begin therapy earlier.
We now understand that timing matters. Initiating hormone therapy in women under age 60, or within 10 years of menopause, is associated with a far more favorable risk-benefit profile. In these women, estrogen therapy may actually reduce the risk of coronary heart disease, improve insulin sensitivity, and potentially support brain health.
The Cost of Caution
Unfortunately, the fallout from the WHI led to decades of undertreatment. Millions of women were told to avoid estrogen therapy altogether—even when they were suffering from life-disrupting menopausal symptoms. As a clinic specializing in hormone therapy, we’ve seen firsthand the impact this has had. And we’ve also seen just how transformative proper menopausal hormone therapy can be.
Estrogen therapy does far more than reduce hot flashes and night sweats. It improves both the quantity and quality of sleep. It relieves vaginal dryness, itching, discomfort with intercourse, and urinary symptoms—collectively known as the genitourinary syndrome of menopause (GSM). Estrogen supports bone density, reducing the risk of osteoporosis and fractures. And emerging evidence points to benefits in cognitive health when therapy is started early.
The Way Forward
If the FDA ultimately removes the black box warning, it would mark a significant step forward in how we care for women in midlife and beyond. But even more important than any regulatory change is the need to personalize care.
We believe women should begin appropriate menopausal hormone therapy during perimenopause or early in menopause, when the benefits are greatest. Treatment should always be tailored to the individual: the right medication, the right dose, and the right delivery method.
But hormone therapy doesn’t exist in a vacuum. It’s one part of a bigger picture that includes exercise, nutrition, sleep, mental health, and overall well-being. That’s how we approach care in our clinic—and it’s the kind of comprehensive, empowering care that every woman deserves.
