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FDA has removed black box warnings from hormone replacement therapy for menopause.

Findings

Additional insights we found via US Department of Health and Human Services

  1. The agency removed the label in 2025, reversing its 2003 decision to warn women about HRT's links to stroke risk, developing cancer, and heart disease.

  2. Years of accumulating research have found that the risks had been overstated and unnecessarily deterred hormone therapy use. The agency still warns against using certain estrogen-alone products, however, due to elevated endometrial cancer risk.

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