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A Key Update in Hormone Therapy Guidance: FDA Removes “Black Box” Warnings Based on Current Evidence

In November 2025, the U.S. Food and Drug Administration (FDA), together with the U.S. Department of Health and Human Services (HHS), announced a significant shift in the regulatory approach to menopausal hormone therapy (MHT), based on a comprehensive review of current scientific evidence.*

After more than 20 years of caution driven by interpretations of older clinical studies, the FDA has initiated a process to remove the general “black box” warnings for systemic MHT related to cardiovascular disease, breast cancer, and dementia. These warnings were originally based on studies involving patient populations and hormonal regimens that do not reflect contemporary clinical practice.

Current scientific consensus indicates that:

  • In women who initiate hormone therapy within the first 10 years after the onset of menopause or before the age of 60,
  • the benefits of MHT may outweigh the potential risks when patients are appropriately selected and therapy is individualized.

Accumulating evidence suggests that MHT may:

  • effectively relieve vasomotor and other menopausal symptoms;
  • contribute to the maintenance of bone health and reduction of fracture risk;
  • have a positive impact on overall quality of life and long-term health outcomes in appropriately selected patients.

The FDA emphasizes that decisions regarding initiation, type, and duration of hormone therapy should be made collaboratively between the physician and the patient, based on an individual risk profile and clearly defined clinical goals—guided by data rather than fear.

“For more than two decades, bad science and bureaucratic inertia have resulted in women and physicians having an incomplete view of HRT. We are returning to evidence-based medicine and giving women control over their health again.” stated Secretary Kennedy.

“Tragically, tens of millions of women have been denied the life-changing and long-term health benefits of hormone replacement therapy because of a medical dogma rooted in a distortion of risk,” said FDA Commissioner Makary. “For too long, issues of women’s health have been underrecognized. Women and their physicians should make decisions based on data, not fear.”

In this context, contemporary therapeutic options—including alternatives to conventional hormone therapy with established efficacy and favorable safety profiles (e.g., tibolone)—may play an important role in the individualized management of women during menopause.

*HHS Advances Women’s Health, Removes Misleading FDA Warnings on Hormone Replacement Therapy