After two decades, the U.S. Food and Drug Administration (FDA) has removed its most severe safety warning – the “black box” – from all hormone replacement therapy (HRT) products used for menopause and perimenopause. This decision marks a significant turning point in women’s healthcare, ending decades of fear-based messaging that discouraged millions from accessing safe and effective relief.
FDA Commissioner Marty Makary, M.D., stated the agency is “stopping the fear machine steering women away from this life-changing, even lifesaving treatment,” based on a robust review of current scientific evidence.
Why This Matters: Overcoming Decades of Misinformation
For years, all estrogen-containing therapies carried a black box warning introduced after the 2002 Women’s Health Initiative (WHI) study. The study suggested HRT increased risks of breast cancer, heart attacks, strokes, and dementia. This led to widespread fear and a dramatic decline in HRT prescriptions. An estimated 50 million women were denied access to this therapy over the past 23 years.
However, subsequent research revealed these risks were overstated and misunderstood. The WHI data primarily reflected outcomes in women averaging 63 years old, using outdated hormone formulations (conjugated equine estrogens and medroxyprogesterone acetate) no longer commonly prescribed.
New studies demonstrate that when initiated in perimenopause (around age 50), HRT may reduce heart disease risk, protect bone density, and support cognitive health.
The Science Behind the Change
The FDA reevaluated the data and found large-scale studies linking appropriately prescribed HRT to improved short- and long-term health outcomes. Evidence showed lower risks of Alzheimer’s disease, heart attack, and hip fracture in women using HRT.
Only one black box warning remains: the risk of endometrial cancer in women taking estrogen without progesterone. Combining estrogen with progesterone remains standard practice for women with a uterus to mitigate this risk.
Steven Fleischman, M.D., president of the American College of Obstetricians and Gynecologists, supports the decision, noting it will “make estrogen products more accessible and improve women’s lives” while reaffirming that therapy “is not without risk” and requires individualized discussion.
A Long-Overdue Course Correction
This decision is more than a regulatory update; it’s a cultural correction. For years, women have been told to “tough it out” through menopause, despite over 80% experiencing debilitating symptoms such as hot flashes, mood swings, weight gain, and sleep disruption, lasting an average of eight years.
Many physicians still receive outdated education on menopause, perpetuating the myth that it’s a brief, mild transition. The FDA’s announcement acknowledges this and brings science back to the forefront of care.
What This Means Moving Forward
The removal of the black box warning allows more doctors to prescribe HRT and more women to make informed decisions based on evidence, not fear. While HRT isn’t one-size-fits-all, when initiated appropriately, it can be safe and beneficial.
Working with a menopause specialist ensures treatment is tailored to individual needs, goals, and medical history. Hormone therapy is most effective when combined with a healthy lifestyle – regular exercise, strength training, nutrient-rich diet, restorative sleep, and stress management.
The Takeaway
The removal of the black box warning is a landmark shift in women’s health, affirming that their comfort, longevity, and well-being matter. Millions of women can now access evidence-based care without unnecessary fear
