The U.S. FDA has removed its ‘boxed warning’ from six menopausal hormone replacement therapy (HRT) drugs, a decision that is based on a comprehensive review of the scientific literature.
The process of removing the warnings began in November 2025, which led 29 pharmaceutical companies to submit proposed labeling changes. This first set of approvals covers four categories of HRT: systemic combination therapy, systemic estrogen-alone therapy, systemic progestogen-alone therapy for women with uterus using systemic estrogen, and topical vaginal estrogen therapy. The risk statements removed related to cardiovascular disease, breast cancer, and probable dementia.
The aim of removing labels is to help women in menopause make better-informed decisions about treatment for their symptoms. The FDA encourages women to work with a health care provider and consult labels for more information about the drugs’ risks and benefits.