
Versha Pleasant and Kari Ring
Feb 5, 2026
"On November 10, 2025, the US Department of Health and Human Services announced that the US Food and Drug Administration would begin removal of black box warnings for menopausal hormone therapy (MHT). This pivot follows a significant period of trepidation toward MHT after the Women’s Health Initiative findings that demonstrated increased breast cancer risk (6 additional breast cancer cases annually per 10 000 person-years for ages 50-59 years)1 with combined conjugated equine estrogen and medroxyprogesterone acetate. (Although the term MHT is often broadly used, the focus of this article is on systemic hormone therapy [combined estrogen plus progesterone and estrogen alone] as opposed to localized hormone therapy [specifically vaginal estrogen].) Warnings persisted even when studies published since the early Women’s Health Initiative publications demonstrated discrepancies in risk based on factors such as combined estrogen plus progesterone vs estrogen alone (where estrogen alone did not increase breast cancer risk, with 5 fewer breast cancers per 10 000 person-years for ages 50-59 years),1 formulation (medroxyprogesterone acetate carrying higher risk than micronized progesterone2), and age at MHT initiation (with initiation before age 60 years or within 10 years of menopause possibly providing more benefit and less risk).3 These subsequent data allow for improved clinical stratification for which risk remains for certain patients, and benefits could outweigh risks for others. Benefits could include decreased vasomotor symptoms, decreased bone fracture risk, possible decreased cardiovascular risk, and possible improvement in quality of life. With the removal of MHT black box warnings, a lingering question still remains: what does this mean for current breast cancer survivors or the 1 in 8 women who will develop breast cancer in their lifetime?
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