FDA Moves to Remove Long-Standing Cancer and Heart Risk Warnings from Menopausal Hormone Therapy

The U.S. Food and Drug Administration has announced plans to eliminate long-standing boxed warnings on hormone replacement therapies (HRT) for menopausal women, reversing decades of cautionary labeling about potential cancer and heart disease risks. The decision, made without convening a formal advisory committee, follows a review of scientific evidence, feedback from an expert panel in July, and a public comment period.

HHS Secretary Robert F. Kennedy Jr. said the updated stance aims to correct years of fear surrounding treatments that can ease severe menopausal symptoms such as hot flashes. The original warnings stemmed from early-terminated Women’s Health Initiative trials that linked combined hormone therapy to increased breast cancer and cardiovascular risks, though later research has shown more mixed or even beneficial outcomes.

FDA Commissioner Martin Makary, a long-time critic of the warnings, emphasized the need to reassess HRT’s benefits and risks. Alongside the policy shift, the FDA approved a generic version of Premarin and a non-hormonal therapy for hot flashes.

16-11-2025