Hormone Therapy in Menopause: Moving Beyond the Black Box Warning

Lilian White, MD
March 23, 2026

Symptoms of menopause affect nearly 80% of women. Hot flashes, genitourinary syndrome, mood changes, sleep disturbances, and sexual dysfunction are commonly cited as symptoms of menopause, but they may also overlap with symptoms of aging, according to some sources. In November 2025, the US Food and Drug Administration (FDA) announced the removal of the black box warning for menopausal hormone therapy (MHT), including the elimination of the previous caution to prescribe MHT at the lowest dose for the shortest duration possible. This change also included the removal of warnings that MHT increased risk of cardiovascular disease, stroke, breast cancer, and early dementia. 

A pair of editorials was recently published in AFP on the benefits and harms of MHT. Menopause Management: When Hormone Therapy Is Appropriate reviews more favorable evidence for the appropriate use of MHT, and Menopausal Hormone Therapy: Limited Benefits, Significant Harms takes a more cautious approach to treatment. It is helpful to consider the evidence related to selected indications for treatment rather than MHT in its entirety.

Vasomotor Symptoms: Some of the most supportive, higher quality evidence for the use of MHT is in the context of treating vasomotor symptoms of menopause (eg, hot flashes, night sweats). The benefits of hormone therapy outweigh the risks in women without contraindications who are younger than 60 years or within 10 years of menopause, according to the North American Menopause Society. The National Institute for Health and Care Excellence (NICE) likewise recommends offering MHT to women with vasomotor symptoms associated with menopause. Timing and duration of MHT remains an area of debate. The FDA’s updated safety guidance for MHT recommends personalizing recommendations by product type and patient history. 

Osteoporosis: According to NICE guidelines, current use of MHT is associated with a significantly lower risk of fragility fractures compared with not using MHT. This benefit is maintained when MHT is discontinued. NICE has published discussion aids to support shared medical decision-making for MHT based on medical conditions, including osteoporosis. 

Low Libido: Topical testosterone may be recommended for women with low sexual desire if MHT alone is not effective, according to NICE guidelines. An FPIN Clinical Inquiry recently corroborated this finding. A Cochrane for Clinicians article notes that MHT with systemic estrogen in early postmenopausal women slightly improves sexual function, but evidence is insufficient to recommend MHT for sexual function alone. This is similarly noted in Medicine by the Numbers, which assigns MHT a yellow rating for unclear benefits.

For additional information on MHT and other options for the management of symptoms from menopause, see AFP by Topic on menopause and CME on the Go.