Experts advocate for the removal of the black box warning on menopause hormone therapies, asserting their safety and effectiveness.
The black box warnings on hormone therapies (HT) for menopause, first introduced by the Food and Drug Administration (FDA) in 2003 following the 2002 Women’s Health Initiative (WHI) study, have been the subject of ongoing debate. The warnings, which are the FDA's strongest, were intended to alert patients and clinicians about the serious long-term risks associated with menopause hormone therapy, particularly increased risks of breast cancer, strokes, blood clots, heart disease, and dementia.
However, recent expert consensus and FDA panel discussions suggest that these warnings may be outdated and overly broad, particularly for low-dose vaginal estrogen formulations. The risks found in the WHI study were mostly observed in older women (60+) and those using systemic HT for prevention rather than symptom management in early menopause (around average age 51).
Low-dose vaginal estrogens, often prescribed for local symptoms such as vaginal dryness and painful intercourse, have minimal systemic absorption and carry much lower risks. A panel convened by the FDA in July 2025 overwhelmingly recommended removing or revising the black box warnings for these lower-risk products.
The benefits of hormone therapy include significant relief from menopausal symptoms such as hot flashes, vaginal atrophy, and mood disturbances, as well as prevention of osteoporosis and improved quality of life. However, systemic therapies carry risks depending on dose, duration, patient age, and health profile. The benefit-risk balance is more favorable when HT is started near menopause onset and used at the lowest effective dose for the shortest needed duration.
Different hormone therapies vary in formulation, systemic absorption, benefits, and risks. Systemic estrogen-progestin therapy, which delivers hormones systemically, is effective in relieving symptoms but carries increased risks, particularly in older women or long-term use. Systemic estrogen-only therapy, for women without a uterus, has lower risks but still includes the risk of blood clots and stroke.
The ongoing debate reflects evolving understanding of hormone therapies, emphasizing individualized risk assessment and the need for nuanced labeling rather than blanket black box warnings. FDA Commissioner Dr. Marty Makary has argued that systemic hormone therapy can reduce the risk of cardiovascular disease when started within 10 years of the onset of menopause.
Women experiencing significant menopause symptoms should speak with their physicians about lifestyle measures, hormonal and nonhormonal prescription therapies, and preventive care to improve heart health and prevent bone loss. The Menopause Society has a searchable database of clinicians who are certified menopause practitioners and trained to guide women through this transition.
[1] FDA Panel Recommends Revising Black Box Warnings on Hormone Therapies (2025) [2] Women's Health Initiative (WHI) Study (2002) [3] Makary, M. (2023) Menopause Hormone Therapy: A New Perspective [4] JAMA (2022) Updated Analysis on Safety and Efficacy of Hormone Therapy for Menopause Symptoms
- The ongoing debate over black box warnings on hormone therapies for menopause involves discussions about revising these warnings, as low-dose vaginal estrogen formulations may have minimal systemic absorption and lower risks.
- The health benefits of hormone therapies for women's health, particularly in management of menopausal symptoms and prevention of osteoporosis, should be considered in an individualized risk assessment, taking into account factors such as dose, duration, age, and health profile.
