Advancing Mature Women's Health

Change is expected to reduce fear and stigma, improving access to safe, effective hormone treatments for midlife women.

Toronto, November 12, 2025 — The Canadian Menopause Society welcomes the FDA’s removal of the “Black Box’ warning from menopausal hormone therapy (MHT) labels. This update aligns with current evidence, reduces stigma, and may encourage more women to consider safe, effective menopause treatments. 

“For too long, an outdated warning increased anxiety and discouraged women and clinicians from discussing hormone therapy,” said Dr. Céline Bouchard, President of the Canadian Menopause Society. “The FDA’s action reflects research and clinical evidence that, for properly selected women, modern menopausal hormone therapy offers significant benefits with low absolute risks.”

Why this change matters 

• The change reduces stigma and fear, helping women feel more comfortable exploring hormone therapy with clinicians.
   
• Individualized choices: Clinicians and patients should carefully evaluate different options, including doses and routes of administration (e.g. systemic use such as transdermal, oral versus vaginal/local use), to align with health profiles and preferences. 

“MHT labeling should be based on the best evidence and promote safety, rather than instill fear or stigma.”  said Dr. Claudio Soares, Executive Director of the Canadian Menopause Society. “There are still important nuances around MHT use, but the removal of the black box will allow women and clinicians to focus on risk assessment and shared decision-making.”

What continues to matter in care​​​​​​​

• Safety is paramount: Women under 60 or within 10 years of their final menstrual period have a favourable benefit–risk profile for MHT use. Also, important contraindications and risk factors should be considered when guiding tailored choices.
   
• One size does not fit all: The correct dose, route, and duration should be individualized and reassessed regularly. Low-dose vaginal estrogen for urogenital symptoms has minimal systemic absorption and a strong safety profile.
   
• MHT remains the gold standard for vasomotor symptoms, effectively relieving hot flashes, night sweats, and contributing to improving sleep, mood, and overall functioning.
   
• Better urogenital and sexual health: Vaginal local estrogen can be particularly helpful to relieve vaginal dryness, pain with intercourse, and urinary symptoms.
   

IMPORTANT for Canadian patients: The FDA decision applies to U.S.-approved products. CMS will continue to engage with Health Canada and other Canadian interested parties to ensure labelling and guidance reflect up-to-date evidence and support informed choice for women across the country.
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About the Canadian Menopause Society:  The Canadian Menopause Society (Société canadienne de la ménopause) is a national, multidisciplinary organization of clinicians, researchers, and patient advocates dedicated to improving the health and quality of life of people experiencing menopause. We advance education, clinical excellence, and research, and champion access to evidence-based care.

Media contact: Dr. Claudio Soares, Executive Director, Canadian Menopause Society 
Email: yvav@fvtznzrabcnhfr.pbz 

Disclaimer: This release is for information only and is not a substitute for professional medical advice. Always consult a qualified health professional about your individual circumstances.