A 12-member expert panel convened by the US Food and Drug Administration on 17 July recommended that the agency remove the black-box warnings attached to hormonal treatments used to relieve hot flashes and other menopause symptoms. The boxed cautions, introduced after the Women’s Health Initiative study in 2002 linked combined estrogen-progestin therapy to higher risks of breast cancer, heart disease and stroke, have sharply curtailed prescriptions. Panelists argued that more recent data and newer, lower-dose formulations show the benefits of menopausal hormone therapy outweigh the earlier risk estimates for many patients. They said continued warnings deny women effective relief and may deter physicians from prescribing the drugs even when clinically appropriate. FDA Commissioner Martin Makary told the meeting the agency would “take a hard look” at the recommendation. The FDA will open a public docket for comments before deciding whether to revise labeling, a move that could broaden access to the therapies for millions of women entering menopause each year.
ICYMI: Highlights from yesterday’s expert panel on menopause and HRT for women. “Women deserve policy that reflects the current evidence and not outdated risks.” @heatherhirschMD https://t.co/nkInqr7WoU
Panel urges FDA to remove warnings on hormonal menopause therapy https://t.co/Ea4VD3joXy by @Lilah_Alvarado
F.D.A. Panelists Call for Removal of Warnings on Menopause Treatments https://t.co/3MhhphimS4 https://t.co/lvcd4qRVS0