A Revolutionary Year for Hormone Therapy: Recapping the 2025 Breakthroughs for Men and Women
An Update From Michael Koehler, MD.
Dear Patients,
As we step into 2026, we at Affinity Whole Health are thrilled to reflect on 2025—a truly transformative year for hormone therapy. Significant regulatory changes from the FDA, backed by decades of evolving research, have reshaped how we approach hormone optimization for both women and men. These updates remove longstanding barriers, making safe, evidence-based hormone therapy more accessible than ever. Here's what you need to know about these exciting developments and what they mean for your health.
Landmark Changes for Women: FDA Removes Black Box Warnings on Menopausal Hormone Therapy
For years, menopausal hormone replacement therapy (HRT) carried the FDA's strongest "black box" warning—the prominent label highlighting potential risks of heart disease, stroke, blood clots, and breast cancer. These warnings stemmed largely from the 2002 Women's Health Initiative (WHI) study, which many experts now view as outdated and flawed due to its focus on older women starting therapy later in life and use of synthetic hormone therapy.
In November 2025, the FDA announced the removal of these black box warnings from all estrogen-containing HRT products used for menopausal symptoms. This decision followed a comprehensive review of scientific literature, expert panels, and updated data emphasizing the timing hypothesis: HRT is safest and most beneficial when started before age 60 or within 10 years of menopause onset.
What does this mean for you?
Proven benefits reaffirmed: HRT remains the most effective treatment for hot flashes, night sweats, vaginal dryness, sexual dysfunction, and mood changes. It also prevents bone loss, improves lean body mass, and reduces fracture risk.
Lower perceived risk: The updated labeling shifts focus to individualized benefits, especially for younger postmenopausal women.
Broader options: Creams and patches now carry clearer, less alarming guidance.
This change aligns with positions from the North American Menopause Society (NAMS), which has long advocated for personalized HRT based on the latest evidence.
Progress for Men: Updated Safety Profile for Testosterone Therapy
Men weren't left behind in 2025. Testosterone therapy has faced scrutiny over potential cardiovascular risks, but major studies—like the TRAVERSE trial—have provided reassuring data showing no increased risk of major heart events in properly selected patients.
In February 2025, the FDA required class-wide labeling updates for all testosterone products, reflecting this new evidence and adjusting warnings on cardiovascular effects. Later in December, an FDA expert panel recommended easing restrictions further, supporting expanded access for men with testosterone deficiency.
Key takeaways for men:
Symptom relief: Testosterone therapy effectively improves energy, libido, muscle mass, mood, and cognitive function in men with deficiency.
Safer profile: Large-scale trials confirm benefits often outweigh risks when monitored properly.
Personalized approach: New guidelines emphasize baseline testing, regular monitoring, and lifestyle integration.
What This Means for You: Next Steps
These 2025 breakthroughs don't mean hormone therapy is risk-free for everyone—individual factors like age, health history, and family risks still matter. The best outcomes come from shared decision-making with your provider.
Practical Action Plan:
Schedule a review: Book an appointment with us to discuss how these updates apply to you—whether you're considering starting therapy, adjusting your current regimen, or exploring alternatives.
Prepare questions: Bring notes on your symptoms, medical history, and goals.
Get tested: Comprehensive hormone panels and health screenings ensure safe, tailored treatment.
Stay informed: We'll continue monitoring new research and guidelines.
We're excited about these changes and committed to helping you feel your best. Hormone optimization, when done right, can dramatically improve quality of life. We're here to guide you toward optimal health with the latest evidence-based care.
Warm regards, The Team at Affinity Whole Health
Citations
U.S. Department of Health and Human Services. "HHS Advances Women's Health, Removes Misleading FDA Warnings on Hormone Replacement Therapy." FDA Press Announcement, November 10, 2025. https://www.fda.gov/news-events/press-announcements/hhs-advances-womens-health-removes-misleading-fda-warnings-hormone-replacement-therapy
FDA Fact Sheet. "FDA Initiates Removal of 'Black Box' Warnings from Menopausal Hormone Replacement Therapy Products." November 10, 2025. https://www.hhs.gov/press-room/fact-sheet-fda-initiates-removal-of-black-box-warnings-from-menopausal-hormone-replacement-therapy-products.html
Society for Gynecologic Oncology. "FDA Removes Black-Box Warnings on Hormone Replacement Therapy." November 20, 2025. https://www.sgo.org/news/fda-removes-black-box-warnings-on-hormone-replacement-therapy/
The Menopause Society. "Comments on the FDA Announcement on Hormone Therapy." November 10, 2025. https://menopause.org/press-releases/the-menopause-society-comments-on-the-fda-announcement-on-hormone-therapy
JAMA Network. "Updated Labeling for Menopausal Hormone Therapy." Viewpoint, November 10, 2025. https://jamanetwork.com/journals/jama/fullarticle/2841321
FDA. "FDA Issues Class-Wide Labeling Changes for Testosterone Products." Drug Safety and Availability, February 28, 2025. https://www.fda.gov/drugs/drug-safety-and-availability/fda-issues-class-wide-labeling-changes-testosterone-products
FDA. "Expert Panel on Testosterone Replacement Therapy for Men." December 10, 2025. https://www.fda.gov/patients/fda-expert-panels/fda-expert-panel-testosterone-replacement-therapy-men-12102025
Regulatory Affairs Professionals Society. "FDA Panel Calls for Easing Restrictions on Testosterone Replacement Therapy." December 12, 2025. https://www.raps.org/news-and-articles/news-articles/2025/12/fda-panel-calls-for-easing-restrictions-on-testost