Panel urges FDA to remove boxed warning on women’s hormone therapy
FDA advisers suggest removing boxed warning from certain estrogen products: An advisory panel has recommended that the FDA remove boxed warnings from labels of vaginal estrogen products, citing a lack of data to support the warnings and noting that they discourage use. The warnings, which highlight risks for breast cancer, blood clots, and stroke, were introduced following a 2002 study of estrogen’s effects on women in menopause.