The Food and Drug Administration announced it will remove the black box safety warnings from estrogen-containing therapies used for menopause and perimenopause. The removed warnings had cautioned that these treatments could raise risks of certain cancers, dementia, heart attacks and strokes. The agency says it will replace the prominent warnings with more detailed, nuanced information in drug labeling so women and clinicians can make better-informed decisions.
FDA Commissioner Marty Makary said the move follows a review of recent evidence and aims to end what he called a “fear machine” that discouraged many women from pursuing potentially beneficial treatment. The agency cited studies suggesting hormone therapy may lower risks of Alzheimer’s disease, heart attack and hip fracture in some cases, and an analysis indicating earlier initiation of therapy could reduce mortality for some women.
The decision reverses decades of guidance that were heavily influenced by the 2002 Women’s Health Initiative (WHI) report, which associated hormone therapy with higher risks of cancer and stroke. Subsequent research, however, has suggested those risks may have been overstated and that timing matters—starting therapy earlier in the menopausal transition may carry different benefits and risks than starting later.
The FDA convened an expert panel in July and opened a public docket, receiving nearly 3,000 comments by the Sept. 24 deadline. Professional groups, including the American College of Obstetricians and Gynecologists (ACOG), submitted formal responses. ACOG’s president, Dr. Steven Fleischman, said the labeling changes should increase access and support shared decision-making, but emphasized that systemic estrogen is not risk-free and decisions should be individualized.
ACOG also urged clearer distinctions between low-dose vaginal estrogen—often used for local genitourinary symptoms—and systemic estrogen delivered by pills or patches, arguing they should be evaluated separately. The organization criticized the July expert panel as a limited substitute for a full advisory committee meeting and urged the FDA to hold separate advisory committee sessions with broader public engagement before making major labeling changes.
Commissioner Makary defended the agency’s process, saying advisory committees can be slow, costly and sometimes affected by conflicts, and that expert panels offered a faster route to review the evidence. The FDA said the weight of recent studies supports updating the boxed warnings and providing more granular risk information in package inserts.
Advocates for change say many women were discouraged from hormone therapy after the 2002 WHI findings; the FDA noted that menopausal symptoms affect more than 80% of women, can last on average eight years, and may be severe and disabling—impacting sleep, mood, weight and quality of life.
ACOG reiterated that systemic estrogen carries potential harms and should be prescribed after individualized risk assessment. The organization continues to call for full advisory committee deliberations to ensure transparency and public input. Despite those calls, the FDA is moving ahead with the planned label revisions based on its recent review and expert-panel recommendations.