Prescribing menopausal hormone therapy after the label change

What changed

In 2025 the FDA announced it would remove the boxed warning from menopausal hormone therapy labels, and updated labels began appearing in 2026. The change reflects reanalysis showing that risks seen in WHI were driven largely by older women starting therapy many years after menopause. Absolute risks and contraindications still apply.

Who benefits most

• Healthy people under 60 or within 10 years of the final period with bothersome vasomotor symptoms

• Premature ovarian insufficiency or early menopause, until the usual age of menopause

• Those at high fracture risk who also have symptoms

Choosing a regimen

• Transdermal estradiol: observational data show lower venous thromboembolism risk than oral estrogen; preferred with obesity, migraine or higher VTE risk

• Uterus present: add a progestogen; micronized progesterone is a common choice

• Start low, titrate to symptoms; estradiol levels are not needed for routine dosing

Contraindications

• Unexplained vaginal bleeding

• Current or past breast or endometrial cancer, with rare specialist exceptions

• Prior VTE, stroke or myocardial infarction

• Active liver disease

Duration

There is no mandatory stop age. The Menopause Society advises against routinely stopping at 65; continue with an annual, individualized review of benefits and risks.