- Start
- Feb 12, 202690% CONFIDENCEfrom the source
FDA Approves First HRT Labels Without the Breast Cancer Boxed Warning
- On 12 February 2026 the FDA approved labeling changes for six menopausal hormone therapy (HRT) products, removing cardiovascular disease, breast cancer and probable dementia from their boxed warnings[1][3]
- The first batch covers all four HRT categories: systemic oestrogen-plus-progestogen, systemic oestrogen alone, systemic progestogen alone and topical vaginal oestrogen[1]
- At the FDA's request, 29 drug companies have submitted proposed label changes, so more products will follow[1]
- The removal began with the HHS announcement of November 2025; the endometrial cancer warning on systemic oestrogen-alone products stays[1][4]
- The FDA says about 41 million US women were aged 45 to 64 in 2020, yet only about 2 million women aged 46 to 65 received a hormone-therapy prescription[1]
References 484% CONFIDENCE
The first entry is always the pin's source. Overall confidence is a weighted average of how firmly each reference supports the start and end times used above; a reference counts half as much for every 180 days older than the newest.
- [1]90%fda.gov/news-events/press-announcements/fda-approves-labeling-changes-menopausal-hormone-therapy-productsfda.gov· Posted Sep 25, 2026· Starts Feb 12, 2026 ✓· 47% of score
The FDA[4] news release is headed "For Immediate Release: February 12, 2026" and says the FDA "has approved drug labeling changes to six menopausal hormone therapy products".
- [2]70%FDA removes black box warning from hormone therapy (ABC News)youtube.com· Published Feb 19, 2026· 20% of score
Makary explains the decision to lift the warning and addresses safety and supply concerns.[1]
- [3]85%FDA Approves Labeling Changes to Menopausal Hormone Therapy Products (The ASCO Post)ascopost.com· Published Feb 12, 2026· 20% of score
Reports the six approved label changes, one batch spanning all four HRT categories, with 29 companies having submitted changes.[1]
- [4]85%HHS Advances Women's Health, Removes Misleading FDA Warnings on Hormone Replacement Therapyfda.gov· Published Nov 10, 2025· 14% of score
The November 2025 announcement that began the process and kept the endometrial cancer warning for systemic oestrogen-alone products.[1]
Suggest a correction
Something missing or wrong? Say it in your own words: a link that backs this pin up, a different start or end date and why, or a fact it lacks or gets wrong. The AI checks it against this pin's sources, searches for better ones, and adds any page that backs you up. The pin's own sources still count most.
