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FDA Removes Black Box Warnings From Menopause Hormone Therapy

FDA Removes Black Box Warnings From Menopause Hormone Therapy
Above: Robert F. Kennedy Jr. and Martin Makary in the Oval Office, on Nov. 6, 2025. Image copyright: Aaron Schwartz/Bloomberg/Getty Images

The Spin

Pro-government narrative

The FDA's removal of black box warnings from hormone therapy represents a historic victory against decades of fear-mongering that denied millions of women life-changing treatment. These warnings were based on misinterpreted 2002 data from older women using outdated formulations, creating a medical dogma that ignored gold-standard science showing HRT reduces mortality, heart disease and Alzheimer's risk by up to 50%.

Opposition narrative

Removing the black box warnings on hormone replacement therapy (HRT) could increase access to hormone therapy for women experiencing menopausal symptoms, and this change is welcomed by most experts. However, like all medications, systemic estrogen products are not without risk. It is important not to downplay significant threats such as breast cancer and blood clots, which research has linked to these treatments. Effective health policy should prioritize proven facts and personalized care, rather than sensational claims that might lead to increased prescriptions and potentially preventable cancers.


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© 2025 Improve the News Foundation. All rights reserved.Version 6.17.0

© 2025 Improve the News Foundation.

All rights reserved.

Version 6.17.0