FDA Removes Black Box Warnings on Menopausal Hormone Therapy | Couri Center

FDA Removes Black Box Warnings on Menopausal Hormone Therapy: What This Means for Women. In Other Words, It’s About Time!

By Dr. Michele Couri, MD, FACOG, ABIHM @couricenter

For more than two decades, menopausal hormone therapy (HT) has been clouded by confusion and controversy. As many of us remember, after the 2002 release of the Women’s Health Initiative (WHI) findings, millions of women were abruptly taken off estrogen—often overnight—and told it was too dangerous. Prescriptions plummeted, clinicians became apprehensive, and women were left to struggle with debilitating menopausal symptoms and long-term health risks without relief.  Furthermore, there emerged an entire generation of young physicians and other healthcare providers who have not been trained to prescribe menopausal hormone therapy.  This will have repercussions for years to come.  

Yet we now know that the WHI data were widely misinterpreted, and the sweeping fear that followed cost women decades of evidence-based care.

Today, we are finally seeing a long-overdue correction, and I am so thankful.  On November 10, 2025, the FDA did something extraordinary – it removed the “black box” warning on menopausal hormone therapy.  

A Historical Perspective

As early as the mid-20th century, clinicians noted that women who underwent premenopausal bilateral oophorectomy (surgical removal of both ovaries before natural menopause) faced sharply higher rates of cardiovascular disease—a signal that estrogen offers important cardioprotective benefits. In fact, the FDA first approved estrogen therapy for menopausal symptoms back in 1942.  Similarly, physicians have been safely prescribing testosterone for women since 1938.

Since then, an ever-growing body of evidence has highlighted the profound benefits of hormone therapy when started at the right time—particularly within 10 years of menopause onset or before age 60.

What Current Evidence Shows

When appropriately prescribed, hormone therapy has been associated with:

• 25–50% reduction in fatal cardiovascular events
• 50–60% reduction in bone fractures
• 64% reduction in cognitive decline
• 35% lower risk of Alzheimer’s disease
• Significant relief from hot flashes, night sweats, sleep disruption, mood changes, joint pain, and genitourinary symptoms

Importantly, no clinical trial has ever shown an increased risk of breast cancer mortality (death) from hormone therapy, and the small increase in breast cancer diagnoses seen in the original WHI study has since been attributed to one progesterone formulation—medroxyprogesterone acetate—which we rarely use today.

Why Timing Matters

One of the biggest limitations of the WHI trials was that most participants were far older than today’s typical HT patient—the average age was 63. Many had gone a decade or more without estrogen, long after cardiovascular changes such as arterial stiffening had already set in.

We now understand that initiating HT early—within 10 years of menopause—offers the greatest benefit and the lowest risk. Data in this age group even show reductions in all-cause mortality over the subsequent decade.

A Major Shift: The FDA Removes Black Box Warnings

In July 2025, the FDA’s Expert Panel revisited the totality of evidence—including WHI reanalysis and decades of newer research—and recommended major updates to hormone therapy labeling. As a result, the FDA is removing the boxed warnings from:

• Combined estrogen–progestogen products
• Estrogen-alone products
• Other estrogen-containing formulations
• Progestogen-only therapies

The only remaining boxed warning will apply to unopposed estrogen in women with a uterus—because adding a progestogen prevents endometrial cancer.

This is a pivotal moment for women’s health.

What Else Is Changing?

The updated FDA labels will now:

• Remove the outdated recommendation to use “the lowest dose for the shortest duration.” There has never been a study to back up this recommendation.  It was simply a guideline that was put in place without clinical evidence.  So much for “evidence-based” medicine.  I have always believed that care needs to be individualized—exactly as we practice at the Couri Center.
• Distinguish between systemic hormone therapy and local vaginal estrogen, emphasizing the exceptional safety of the latter.  Local vaginal estrogen is safe for every menopausal woman, even those with breast cancer or a history of breast cancer.  Local vaginal estrogen not only reverses the vaginal dryness, painful intercourse, and urinary symptoms encountered in menopause, it can reduce the risk of urinary tract infections by 50%.
• Provide product-specific safety information rather than broad, one-size-fits-all warnings.
• Include guidance on timing, emphasizing initiation under age 60 or within 10 years of menopause for optimal benefit-risk balance.

These changes aim to offer women clearer, more nuanced information—reflecting what high-quality evidence has shown for years: hormone therapy is both safe and profoundly beneficial for appropriately selected women.

Why This Matters

Nearly 50 million women in the U.S. are navigating perimenopause or menopause. Many suffer unnecessarily because they were told hormone therapy is dangerous—when in truth, for the majority of symptomatic women in their 40s, 50s, and early 60s, the opposite is true.

This FDA action represents an important step toward restoring confidence in one of the most effective therapies we have to improve women’s long-term health and quality of life. According to Dr. Makary, Commissioner of the FDA, “with the exception of antibiotics and vaccines, there may be no medication in the modern world that can improve the health outcomes of older women on a population level more than hormone therapy.”  I could not agree more.

At the Couri Center, we have long practiced safe, effective, individualized hormone therapy. I have been advocating the following for our patients as it pertains to menopausal hormone therapy:  

1. No fear-based messaging
2. No shame
3. No outdated WHI-era dogma
4. No dismissal of symptoms
5. No “just deal with it”
6. No gendered minimization of women’s suffering

These FDA updates reinforce what we have seen daily in our practice: when started at the right time and tailored to each woman’s needs, hormone therapy is safe, transformative, and life-changing.

Considering Hormone Therapy? We Are Here to Help.

If you are struggling with menopausal symptoms or are curious whether hormone therapy is right for you, we are here—as always—to guide you with the most current science and compassionate individualized care.  To schedule online, use the form below or call 309-692-6838.  New patients are welcome.

To Your Health,

Dr. Couri

Dr. Michele Couri, MD, FACOG, ABIHM, is the founder and Medical Director of the Couri Center for Gynecology & Integrative Women’s Health in Peoria, IL, specializing in advanced gynecology, hormone health, and evidence-based integrative wellness for women.

Sources Used: 

Makary MA, Nguyen CP, Høeg TB, Tidmarsh GF. Updated Labeling for Menopausal Hormone Therapy. JAMA. Published online November 10, 2025. doi:10.1001/jama.2025.22259

Tan-Kim J, Shah NM, Do D, Menefee SA. Efficacy of vaginal estrogen for recurrent urinary tract infection prevention in hypoestrogenic women. Am J Obstet Gynecol. 2023 Aug;229(2):143.e1-143.e9. doi: 10.1016/j.ajog.2023.05.002. Epub 2023 May 11. PMID: 37178856.

Traish AM, Feeley RJ, Guay AT. Testosterone therapy in women with gynecological and sexual disorders: a triumph of clinical endocrinology from 1938 to 2008. J Sex Med. 2009 Feb;6(2):334-51. doi: 10.1111/j.1743-6109.2008.01121.x. Epub 2008 Dec 9. PMID: 19138368.

Disclaimer
This page is for educational purposes only and is not medical advice. Please consult your healthcare provider for personalized recommendations or schedule an appointment with the Couri Center.