FDA

Six menopausal hormone therapies receive first round of FDA‑approved label updates

February 16, 2026

FDA has approved the first wave of labeling changes for six menopausal hormone replacement therapy (HRT) products, removing boxed warnings about cardiovascular disease, breast cancer, and probable dementia. This action follows FDA’s November 2025 assessment of the current relevant literature, including a reanalysis of data from younger cohorts of patients who initiated HRT within ten years of the onset of menopause, and its subsequent request for manufacturers to submit revised labels. The newly updated products span systemic estrogen‑alone, systemic combination, progestogen‑alone, and topical vaginal estrogen therapies; drug labels can be viewed here. Randomized studies show that initiating HRT within 10 years of menopause onset, typically before age 60, can reduce all‑cause mortality and fracture risk. FDA stated that the changes are intended to provide women and clinicians with clearer, science‑based information to guide individualized decision‑making about menopause symptom management.

Source:

(2026, February 12). FDA. FDA Approves Labeling Changes to Menopausal Hormone Therapy Products. https://www.fda.gov/news-events/press-announcements/fda-approves-labeling-changes-menopausal-hormone-therapy-products