Estrogen Hormone Therapy Label Modernization
Resolved
On November 10, 2025, Dr. Marty Makary’s FDA announced that it would remove black-box safety warnings from estrogen hormone-therapy products used for menopause symptoms, replacing them with a more nuanced description of risk in the package insert. Makary said the agency was acting to “stop the fear machine steering women away from this life-changing, even lifesaving treatment,” and he said the decision was based on a robust review of the evidence.
The change completed a through-line from Makary’s 2024 book Blind Spots, whose chapter “OMG HRT” argues that fear over hormone replacement therapy was driven by misinterpreted data. The American College of Obstetricians and Gynecologists welcomed the new labels as an improvement to shared decision-making between patients and clinicians.
Because the label change was enacted before Makary’s May 12, 2026 resignation, it is a completed action rather than an interrupted one. Makary has also argued publicly that the old warnings acted as a “fear machine” that denied women the benefits of hormone therapy.
Timeline
- 2024: Makary’s Blind Spots argues fear over HRT was driven by misinterpreted data (ch. 2, “OMG HRT”).
- November 10, 2025: Makary’s FDA announces removal of black-box warnings from estrogen hormone-therapy products, replacing them with nuanced risk language; ACOG welcomes the change.
- May 12, 2026: Makary resigns; the label modernization stands as an enacted policy.
