The Food & Drug Administration (FDA) recently announced that it would remove the strict black box warnings from most hormone replacement therapies (HRT) for menopause. Drugmakers are being asked to update labels to reflect the newer science that shows the benefits of HRT.
Hormone Replacement Therapy includes prescription estrogen, progesterone, and sometimes testosterone therapy prescribed for women in menopause to replace the hormones that decline in this stage of life. Menopause symptoms are typically treated with HRT, lifestyle changes, alternative therapies or other medications – or in many cases not treated at all.
Right now, over 1 billion women worldwide are in perimenopause, menopause, or postmenopause. Projections indicate this number will reach 1.2 billion by 2030 as women live longer. Estimates vary, but some suggest as many as 50 million women enter menopause every year across the globe. The average age of onset is 51.
As women transition through the stages of menopause, they experience a variety of symptoms, including hot flashes, vaginal dryness or atrophy, sleep problems, mood swings, decreased sex drive, weight gain, cognitive issues – and more.
HRT can not only effectively treat these symptoms, but it also can also have a protective benefit for cognitive decline, bone loss/osteoporosis and cardiovascular risk in women as they age. There is clear consensus now on the benefits of HRT, especially for women starting therapy early in menopause.
The recent removal of the black box warnings on HRT – announced on November 10, 2025 – reverses the original January 2003 decision by the FDA when they first issued the black box warnings, citing the potential increased risk for certain health conditions with hormone replacement therapy.
According to FDA Commissioner Marty Makary, this decision to remove the black box warnings followed an extensive review of scientific literature, as well as input from an expert panel in July. It also included a public comment period.
The National Menopause Foundation welcomed the move, as did many longtime proponents of HRT, including Dr. Goldstone.
Historically, hormone replacement therapy had been widely prescribed, including to protect women from chronic diseases, especially heart disease, for decades before the black box warning was added in 2003. HRT use plunged after a 2002 Women's Health Initiative study found it could raise the risk of strokes, breast and ovarian cancers, and other serious conditions including probable dementia.
A black box warning is the most severe warning the FDA can apply to a prescription medication, as it indicates serious or potentially fatal side effects.
The FDA is removing these warnings from HRT products due to more recent research disproving those risks. Those broad warnings based on older studies were misleading for many women and deterred doctors from prescribing HRT. The stigma still exists, and even with the black box warning removed, it will be crucial to educate doctors who may still be leery of prescribing hormone replacement therapy.
The FDA is working with healthcare companies to update the black box warnings currently on HRT products, removing those stated risks for cardiovascular disease, breast cancer and dementia. They’re also adding the FDA’s recommendation to start HRT within 10 years of the start of menopause or before age 60, while most women still maintain estrogen receptors in their bodies.
If you’re considering hormone replacement therapy, call our offices at (424) 374-2800 or contact us online today. We offer telehealth services and virtual consultations for your convenience.
Dr. Goldstone's Response to Recent FDA Announcement
As a functional medicine physician with two decades of clinical experience, I have extensively prescribed hormone therapies, consistently observing positive outcomes with a remarkably low incidence of adverse effects among my patients. A critical distinction often overlooked in mainstream discussions, and notably absent from the NYT article, is the difference between synthetic hormones and bioidentical hormones.
Bioidentical hormones, mostly derived from plant sources, are molecularly identical to the hormones naturally produced by the human body. This structural congruence allows for their natural and efficient metabolism by the body's enzymatic systems, setting them apart from synthetic compounds that can be difficult for a human body to metabolize. Our clinical practice overwhelmingly favors bioidentical hormone replacement therapy (BHRT), as it aligns more closely with the body's intrinsic biochemistry.
In my experience, women in perimenopause and menopause who go on a carefully managed BHRT regimen report profound and life-enhancing benefits. These extend beyond mere symptom relief to a significant improvement in overall quality of life, including enhanced mood stability, restoration of healthy sexual function, sustained energy levels, deeper and more restorative sleep, and improved cognitive clarity. Patients frequently express immense gratitude for feeling "like themselves again" - balanced, vibrant, and fully revitalized.
It is imperative to address the concern that imbalanced levels of estrogen and progesterone, whether synthetic or bioidentical, can stimulate cell growth and potentially contribute to cancer. This is precisely why the functional medicine approach to BHRT emphasizes individualized assessment, precise dosing, and meticulous, ongoing monitoring of hormone levels. Under expert medical guidance, this strategy aims to restore optimal hormonal balance safely, thereby mitigating risks often associated with generalized HRT prescriptions and ensuring patient well-being.
