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The US FDA, on February 12, approved labeling changes to six menopausal hormone therapy products, also referred to as hormone replacement therapy, to clarify risk considerations. Specifically, risk statements related to cardiovascular disease, breast cancer, and probable dementia were removed from the boxed warning, which is the agency’s most prominent safety-related warning.
The six products, Prometrium (distributed by Acertis Pharmaceuticals), Divigel (Vertical Pharmaceuticals), Cenestin and Enjuvia (Aspen, manufactured by Teva Women’s Health), Estring (Pfizer), and Bijuva (distributed by Mayne Pharma), span four categories the FDA identified: systemic combination therapy (estrogen plus progestogen), systemic estrogen-alone therapy, systemic progestogen-alone therapy for women with a uterus using systemic estrogen, and topical vaginal estrogen therapy.
In announcing the action, Health and Human Services Secretary Robert F. Kennedy, Jr. said the decision reflected a commitment to update guidance as evidence evolves and to provide patients accurate information “free from exaggeration or fear.” FDA Commissioner Marty Makary said the agency’s intent was to ensure women have “accurate, scientifically grounded information” when making treatment decisions for menopause symptoms.
The FDA said it initiated the removal of these warnings in November 2025, following a comprehensive review of the scientific literature. Upon the FDA’s request, 29 drug companies submitted proposed labeling changes. The six products represent the first batch with approved changes.
The FDA noted it has approved multiple hormone therapies for moderate-to-severe hot flashes, vaginal dryness and discomfort, and prevention of bone loss. It also cited randomized studies indicating women who initiate hormone therapy within 10 years of menopause onset, generally before age 60, have reductions in all-cause mortality and fractures.
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