Contributors: Dr. Adrian Lau, Dr. Laëtitia Michou, Dr. Zahra Bardai, Dr. Marie-Josée Bégin, Dr. Claudia Gagnon, Dr. Alan Low, Dr. Sarah Rydal, Dr. Vithika Sivabalasundaram, Dr. Shirine Usmani, Dr. Sandra Kim
Recommendations from Osteoporosis Canada Rapid Response Team.

On November 10, 2025, the Food and Drug Administration (FDA) announced that it is recommending the removal of “black box” warnings from Menopausal Hormone Therapies (MHT) with regards to increased risks of cardiovascular disease, breast cancer, and probable dementia (1).

This is prompted by a review of relevant literature around MHT since the publication of the Women’s Health Initiative (WHI) in the early 2000s.  Publication of the WHI studies prompted many women to stop MHT abruptly, after investigators reported an increased risk of breast cancer, an increased risk of stroke, a lack of evidence of coronary artery disease prevention, and an increased risk of probable dementia.

For women within ten years of menopausal onset, the benefits of MHT initiation may outweigh the potential risks.  In this population, recent studies demonstrate evidence of a reduced risk of mortality, fractures, heart attacks, cognitive decline, and Alzheimer’s dementia.

As an alternative to bisphosphonate therapy, Osteoporosis Canada supports the use of MHT as a pharmacotherapeutic option for bone health for postmenopausal females aged < 60 years or within 10 years of menopause, who prioritize alleviation of substantial menopausal symptoms (2).

The removal of the black box warnings will reduce bias and misunderstandings about MHT.  Women who are appropriate candidates may have an additional option when considering pharmacotherapies for their bone health.  Osteoporosis Canada recommends that interested individuals discuss with their health care providers, to determine if MHT may be an appropriate treatment option for them. The duration and dose of therapy should be personalized for the individual patient.  Osteoporosis Canada recommends that these decisions be made between the prescriber and individual patient.

Please note that the FDA’s decision only applies to labeling of products sold in the USA.  Pharmaceutical products in Canada are regulated by Health Canada and will continue to carry the black box warnings

References:

1. https://www.fda.gov/drugs/drug-safety-and-availability/fda-requests-labeling-changes-related-safety-information-clarify-benefitrisk-considerations
2. Morin SN, Feldman S, Funnell L, et al.  Osteoporosis Canada 2023 Guideline Update Group. Clinical practice guideline for management of osteoporosis and fracture prevention in Canada: 2023 update. CMAJ. 2023 Oct 10;195(39):E1333-E1348. doi: 10.1503/cmaj.221647. PMID: 37816527; PMCID: PMC10610956.