The FDA has approved labeling changes for six menopausal hormone therapy products, commonly referred to as hormone replacement therapy (HRT). The update removes certain risk statements related to cardiovascular disease, breast cancer and probable dementia from the boxed warning. The labeling updates are intended to ensure that risk information reflects current scientific evidence.
Boxed warnings are reserved for serious or life-threatening risks and are designed to draw immediate attention from prescribers and patients. In this case, the FDA determined that including these risks in boxed warnings no longer reflected the totality of available evidence.
The labeling changes stem from an FDA review initiated in 2025 to reassess whether boxed warnings on menopausal hormone therapy accurately reflected available evidence. Those warnings were added in the early 2000s following findings from the Women’s Health Initiative (WHI), which studied older postmenopausal women and hormone formulations that are no longer commonly used.
Over time, questions were raised about the applicability of those findings to women who typically initiate hormone therapy closer to menopause onset. As part of that effort, the FDA reviewed the scientific literature and requested proposed labeling revisions from manufacturers.
To date, 29 drug companies have submitted updates.
The FDA identified the following products whose prescribing information has been updated: Prometrium (progestogen-alone therapy); Divigel, Cenestin and Enjuvia (systemic estrogen-alone therapies); Estring (topical vaginal estrogen); and Bijuva (systemic estrogen-progestogen combination therapy).
While the boxed warnings have been revised, information on benefits, risks and appropriate use remains included elsewhere in the product labeling.
Menopause is a normal life stage, but its symptoms can significantly affect quality of life and long-term health. Common symptoms include vasomotor symptoms such as hot flashes and night sweats; vaginal, vulvar and urinary tract changes associated with declining estrogen levels; and bone loss that increases fracture risk.
Hormone therapies are FDA-approved for the treatment of moderate-to-severe menopausal symptoms and for preventing postmenopausal osteoporosis in appropriate patient populations.
Evidence from randomized studies has shown that women who initiate hormone therapy within 10 years of menopause onset — generally before age 60 — experience reductions in fracture risk and all-cause mortality.
The FDA stated that the labeling update is intended to support clearer, evidence-based discussions between women and their healthcare professionals, rather than to change approved indications or expand use.
Since 2025, the FDA has issued labeling updates across foods, cosmetics and drugs as part of ongoing reviews of how safety and risk information is presented.
Beyond women’s health, obesity treatments have drawn regulatory attention. In January 2026, the FDA requested the removal of language related to suicidal ideation and behavior from the labeling of certain GLP-1 receptor agonists after a comprehensive review found no increased risk associated with their use.
In the oncology space, Legend Biotech reported that the label for its CAR-T therapy Carvykti (ciltacabtagene autoleucel) was updated to include overall survival benefit compared with
standard therapies, supported by data from the Phase III CARTITUDE-4 trial.
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