FDA Removes Black-Box Warnings From Three Estrogen Patches

Federal health officials approved removing the FDA’s strongest “black box” warnings about breast cancer, cardiovascular disease and probable dementia from three estradiol patches used to treat menopause symptoms. HHS described the statements as outdated and said the changes followed a review of scientific evidence; officials emphasized that updated labeling is part of an effort to support access to hormone therapy when patients and doctors choose it. The action extends February labeling changes for six other menopausal hormone therapy products. It comes amid surging demand and reports that women have struggled to find estrogen patches, though the FDA has not designated the patches as being in shortage. Officials say manufacturers have expanded output and the FDA is reviewing requested label and manufacturing changes intended to increase supply.