Agency cites new evidence of benefits

Dr. Marty Makary, the FDA commissioner, said on Monday that the therapeutic advantages of hormone replacement therapy (HRT) for menopausal women have been systematically undervalued. He highlighted recent clinical studies that suggest a more favorable risk‑benefit balance than previously believed, prompting the agency to reconsider the stringent warning labels.

Critics question the scientific basis

Medical researchers and consumer‑advocacy groups responded with caution, describing the evidence supporting the policy change as insufficient. They urged the FDA to retain the black‑box warnings until longer‑term safety data are available.

What the change means for patients

If implemented, the removal of the black‑box warnings could make HRT more accessible and reduce stigma surrounding its use. However, physicians are expected to continue individualized risk assessments and discuss potential side effects with patients.

Next steps

The FDA plans to publish detailed guidance on the revised labeling later this month, and it will monitor post‑marketing data to ensure patient safety remains a top priority.