FDA to lift warnings on menopause hormone therapy, potentially boosting access

The FDA is asking drug manufacturers to remove black box warnings on hormone replacement therapy for menopause, which could make it easier for women to access the treatment.

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The U.S. Food and Drug Administration (FDA) has announced that it will no longer require the black box warning on hormone replacement therapies—labels that many physicians say have discouraged women from using effective treatments for menopausal symptoms.

Since 2003, these medications have carried the FDA’s most severe caution, warning that hormone therapy could raise the risk of heart attacks, strokes, blood clots, and certain cancers. The warning was originally issued following early findings from the federally funded Women’s Health Initiative, which suggested such risks.

However, over the past two decades, scientific understanding has evolved. Newer studies indicate that for many women—particularly those who begin therapy closer to the onset of menopause—the potential benefits may outweigh the risks, prompting the FDA to remove the long-standing warning.