Overview
- On Monday, the FDA requested that manufacturers remove boxed warnings from numerous estrogen-containing menopause treatments, marking a major shift in federal guidance.
- Agency leaders cited evidence that starting hormone therapy before age 60 or within 10 years of menopause carries a different risk–benefit profile than when initiated later.
- The original warning followed early Women’s Health Initiative findings from older participants, after which prescriptions fell by more than 70% and many women went untreated.
- Officials and experts stressed that therapy remains inappropriate for some patients, including those with prior hormone-sensitive cancers or elevated clot risk, and that risk varies by formulation.
- The move arrives as non-hormonal options expand, including the recent FDA approval of elinzanetant (Lynkuet), and as states advance policies to broaden menopause care access and training.