12/11/2025
The latest IMS statement reminds us of what we’ve championed for years: menopause care must be individualised, balanced, and rooted in evidence — not fear.
Every woman deserves guidance based on her own symptoms, needs, medical profile and personal preferences.
Lifestyle medicine remains the universal foundation.
Non-hormonal therapies have a clear place.
And menopausal hormone therapy (MHT) — when used appropriately — should not be feared, but considered thoughtfully for the right woman at the right time.
IMS Statement: US HHS Revises Black Box Warning for Menopause Hormone Therapy
Secretary Kennedy of the United States Department of Health and Human Services (HHS) has announced the removal of certain sections of the black box warning from all menopause hormone therapies (MHT), including systemic and vaginal preparations. The black box warning noted increased risks of myocardial infarction, invasive breast cancer, pulmonary emboli, deep vein thrombosis, and dementia. HHS stated that it is working with companies to update language in product labelling to remove references to risks of cardiovascular disease, breast cancer, and probable dementia.
In principle, the International Menopause Society (IMS) supports and welcomes consideration of the removal of the black box warning, with appropriate scientific review. Currently that warning applies to all types, all routes of administration, in all individuals. IMS agrees with the removal of these warnings from vaginal estrogen products, given reliable evidence in the medical and scientific literature that the systemic levels of estrogen resulting from vaginal routes of administration and the associate risks are negligible.
However, IMS does not support the removal of all warnings from systemic forms of MHT. Systemic oral or transdermal MHT can increase cardiovascular risks, breast cancer and dementia in certain populations of women, particularly those who initiate hormone therapy at later ages, or who already have evidence of these conditions. For this reason, the IMS maintains that it is important that clinicians inform women of potential risks regardless of any changes to the black box warnings. Individualised weighing of pros and cons, guided by the evidence, should be the principle of prescribing MHT and alternatives in the menopause.
Many women suffer unnecessarily from menopause symptoms, and systemic MHT can be used safely and highly effectively for the treatment of vasomotor symptoms and genitourinary symptoms of menopause, while also preserving preserve bone health. The benefits of MHT outweigh the risks for perimenopausal and younger postmenopausal women with bothersome symptoms and who otherwise have no contraindications. IMS has published World Menopause Day White papers in 2024 on menopause and MHT,https://www.imsociety.org/wp-content/uploads/2024/09/Menopause-and-MHT-in-2024-addressing-the-key-controversies-an-International-Menopause-Society-White-Paper.pdf
and in 2025 on lifestyle medicine,https://www.imsociety.org/wp-content/uploads/2025/10/IMS-White-Paper-The-Role-of-Lifestyle-Medicine-in-Menopausal-Health-2025.pdf which outline our recommended key/core principles of menopause management.
Ultimately, our care of women should be led by the evidence; hence, the latest IMS Recommendations and Key Messages on Women’s Midlife Health and Menopause have been developed from rigorous systematic reviews, and are now in press, endorsed by a number of national, regional and global organisations. These Recommendations will be available online by December 2025 via the IMS website and our journal, Climacteric.
Fundamentally, the IMS believes that the labelling for menopause products should reflect evidence-based guidelines of scientific societies like the IMS and the Menopause Society through a process involving expert representatives of those societies, and that women are best served when scientific societies, healthcare services and pharmaceutical companies disseminate lay language summaries of those evidence-based guidelines to women.
