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. “This decision reflects our commitment to follow the science wherever it leads and to correct course when the evidence demands it,” Health and Human Services Secretary Robert F.
Kennedy, Jr. said .
“By removing these boxed warnings, we ensure that women receive accurate information about hormone therapy—free from exaggeration or fear. A healthcare system worthy of public trust tells the truth, updates its guidance as science evolves, and respects women’s ability to make informed choices about their own health.” 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.
FDA News Releases published a clinical update in Research Highlights on 12 Feb 2026.
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