FDA Removes Black Box Warning from Menopausal Hormone Therapy: What It Means for Women’s Health

Research for post done by an NGJ volunteer Elizabeth Jacob

The U.S. Food and Drug Administration (FDA) has officially announced that it will remove the long-standing black box warning from many hormone replacement therapy (HRT) products used to manage menopausal symptoms. This landmark decision marks a pivotal shift in how menopause care is understood and regulated, and it could transform women’s access to safe, effective treatment options; a change with significant implications for women’s health.

Understanding the FDA’s Decision

On November 10, 2025, the FDA and the U.S. Department of Health and Human Services (HHS) revealed plans to eliminate the broad black box warnings from most estrogen and combination hormone replacement therapies (HRT). The decision follows an expert scientific review, public feedback, and decades of updated research.

For over 20 years, the black box warning, which is the FDA’s most serious caution label, suggested that hormone replacement therapy might raise risks for heart disease, breast cancer, and dementia. These warnings were based on early results from the Women’s Health Initiative (WHI) study in the early 2000s. However, newer data now paint a more nuanced picture.

“The science has evolved. For many women, especially those younger than 60 or within ten years of menopause, the benefits of hormone therapy can outweigh the risks,” stated the FDA announcement.

The agency emphasized that removing the boxed warning does not mean HRT is risk-free. Instead, it reflects more accurate and individualized risk-benefit information, helping women and clinicians make informed decisions about treatment options and women’s health.

Why the Black Box Warning is Being Removed

Research since the WHI has consistently shown that the risks associated with hormone replacement therapy (HRT) depend on age, timing, formulation, and individual health history. Women who begin HRT near the onset of menopause tend to experience more benefits such as relief from hot flashes, improved bone density, and better quality of life, with fewer serious complications.

In contrast, starting therapy years after menopause or at an older age may carry higher risks. This “timing hypothesis” has guided a more personalized approach to menopause management, influencing the FDA’s decision.

According to the HHS Fact Sheet, the boxed warnings have been “misleading and overly broad,” discouraging many clinicians from prescribing HRT even when appropriate.

What Will Change for Patients and Providers

More Informed Conversations

With the warning removed, healthcare providers can focus on shared decision-making, tailoring hormone replacement therapy (HRT) recommendations to each woman’s needs, age, and medical background.

Improved Access and Reduced Stigma

For years, many women avoided HRT because of the intimidating warning label. Removing it may help reduce stigma, encourage open discussions, and increase access to treatment options, especially for those seeking menopause care.

Refined Labeling for Better Clarity

While most boxed warnings are being removed, the FDA will keep the warning about endometrial cancer for estrogen-only therapies used without progesterone in women who still have a uterus. This ensures continued transparency about known risks and supports informed conversations about women’s health and HRT safety.

Support from Medical Organizations

The American College of Obstetricians and Gynecologists (ACOG) applauded the decision, saying it will “increase access to evidence-based menopause care” and help clinicians confidently discuss options with patients.

What This Means for Women’s Health

This change could significantly improve how women experience menopause. Many medical experts now agree that hormone replacement therapy (HRT), when used appropriately, is one of the most effective treatments for hot flashes, night sweats, vaginal dryness, and other menopausal symptoms.

It may also support bone health, reduce the risk of osteoporosis, and enhance overall well-being. For women under 60 or within ten years of menopause, HRT is now considered both safe and beneficial for many.

However, ongoing monitoring remains key. Women should continue regular checkups, mammograms, and discussions with their providers about dosage, duration, and alternative treatment options.

A Step Toward Reframing Women’s Health

The FDA’s move is more than a labeling change. It is a signal of progress in women’s health equity. For too long, outdated research and stigma have limited access to hormone replacement therapy (HRT) and other treatments that could improve quality of life. By aligning regulations with modern science, this change empowers women and clinicians to make decisions grounded in evidence, not fear.

As more updated product labels are released in the coming months, women will have better information and more confidence in choosing what’s best for their bodies, with clearer guidance that reflects current research on HRT safety.

If you’re experiencing menopausal symptoms or have questions about hormone replacement therapy (HRT), now is an important time to speak with a qualified healthcare provider. Updated guidance and clearer labeling can help you understand your options and make informed decisions about your health.

Ask your clinician about the risks, benefits, and alternatives, and explore whether HRT or other treatment options may be appropriate for your stage of menopause. Staying informed empowers you to make the best choices for your well-being.

Resources:

American College of Obstetricians and Gynecologists (ACOG). Statement on FDA Label Changes for Estrogen Products. November 2025. https://www.acog.org/news/news-releases/2025/11/acog-president-says-label-change-on-estrogen-will-increase-access-to-hormone-therapy

Associated Press (AP News). FDA Removes Long-Standing Warning from Hormone-Based Menopause Drugs. November 2025. https://apnews.com/article/f26a8208fd3f5174ec96d61140439561

Reuters. U.S. FDA Asks Drugmakers to Remove Black Box Warnings from Menopausal Hormone Therapies. November 2025. https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-chief-makary-asks-drugma kers-remove-warnings-hormone-therapy-2025-11-10/

TIME Magazine. The FDA Just Removed the Black Box Warning from Menopause Drugs and Why That Matters. November 2025. https://time.com/7332940/fda-estrogen-menopause-black-box-warning/

U.S. Department of Health and Human Services (HHS). Fact Sheet: FDA Initiates Removal of Black Box Warnings from Menopausal Hormone Replacement Therapy Products. November 2025. https://www.hhs.gov/press-room/fact-sheet-fda-initiates-removal-of-black-box-warnings-from-m enopausal-hormone-replacement-therapy-products.html

U.S. Food and Drug Administration (FDA). HHS Advances Women’s Health, Removes Misleading FDA Warnings on Hormone Replacement Therapy. November 10, 2025. https://www.fda.gov/news-events/press-announcements/hhs-advances-womens-health-removesmisleading-fda-warnings-hormone-replacement-therapy