United States, Feb. 12 -- The U.S. Food and Drug Administration has approved drug labeling changes to six menopausal hormone therapy products, also known as hormone replacement therapy (HRT), to clarify risk considerations for these drugs. Specifically, risk statements related to cardiovascular disease, breast cancer and probable dementia were removed from the "boxed warning," the agency's most prominent safety-related warning. The FDA initiated the removal of these warnings in November 2025, following a comprehensive review of the scientific literature. At the FDA's request, 29 drug companies have submitted proposed labeling changes. This first batch of six products with approved labeling changes includes products from each of the four cat...