11/12/2025
This week,, the FDA announced that it's removing the "black box" warning—the strongest safety alert that can appear on a drug label—from menopausal hormone therapy (MHT, formerly known as HRT). This ends 22 years of overly broad cautions that scared millions of women away from treatment.
The original 2002 warning came from a flawed study of women averaging 63 years old (well past menopause). Newer evidence suggests that timing matters: MHT initiated within 10 years of menopause appears to be much safer. Not only can it relieve symptoms like hot flashes, sleep difficulties, and genitourinary problems, but it also has potential benefits for heart, bone, and brain health.
The American College of Obstetricians and Gynecologists (ACOG) commended the change, noting they've long advocated for removing barriers to treatment—especially for low-dose vaginal estrogen. As ACOG's president stated, this puts "shared decision-making back in the hands of patients and their trusted clinicians."
Some context: After the 2002 warning, MHT prescriptions dropped 70%. While the process for this reversal has drawn criticism (the FDA used a special panel rather than standard advisory committees), the science supports a more nuanced approach.
Bottom line: This change removes an unnecessary barrier that kept effective treatment from women who could benefit. The updated labels will allow patients and doctors to have honest conversations about individual risks and benefits, not be scared off by warnings based on outdated data from women who started MHT in their 70s.
https://www.acog.org/news/news-releases/2025/11/acog-president-says-label-change-on-estrogen-will-increase-access-to-hormone-therapy
https://www.hhs.gov/press-room/hhs-advances-womens-health-removes-misleading-fda-warnings-hormone-replacement-therapy.html
