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# FDA OKs Pulling Boxed Warnings from 6 HRT Drugs
- URL: https://www.fdaweb.com/fda-oks-pulling-boxed-warnings-from-6-hrt-drugs/
- Published: 2026-02-12T12:00:00.000Z
- Updated: 2026-09-14T13:33:40.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160659

FDA has approved labeling changes for six hormone replacement therapy (HRT) drugs to remove Boxed Warning statements relating to cardiovascular disease, breast cancer, and probable dementia. An agency media [statement](https://www.fda.gov/news-events/press-announcements/fda-approves-labeling-changes-menopausal-hormone-therapy-products?ref=fdaweb.com) quotes HHS secretary **Robert F. Kennedy Jr**. as saying the move “reflects our commitment to follow the science wherever it leads and to correct course when the evidence demands it. 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 agency first [announced](https://fdaweb.com/login.php?sa=v&aid=D5160186&cate=&stid=%241%24SP..z02.%24rC6v9dbTnlHTJBpnxlB1w.&ref=fdaweb.com) its intention to make the changes at an 11/2025 news conference. At that time, it said the Boxed Warnings resulted from the Women’s Health Initiative, a 2002 study involving women with an average age of 63 and using formulations rarely prescribed today. Critics have long argued that the study’s age profile and product differences distorted real-world risk for women in their 40s and 50s experiencing menopause, FDA said.

At FDA’s request, 29 drug companies submitted proposed labeling changes. The news release says the first six products with approved changes include drugs from each of the four categories of HRT for menopausal women — systemic combination therapy (estrogen and progestogen), systemic estrogen-alone therapy, systemic progestogen-alone therapy for women with a uterus using systemic estrogen, and topical vaginal estrogen therapy.