FDA approves label changes for first batch of menopausal hormone therapy products

On February 12, 2026, the FDA approved label changes to the first batch of hormone replacement therapies (HRT) as part of a larger effort to clarify risk considerations for these products, the agency announced in a news release.¹

Specifically, the agency approved removal of language on the risk of cardiovascular disease, breast cancer, and probable dementia from the “boxed warning” labels for 6 therapies. The HRTs with updated labeling include²:

1. Progesterone, USP capsules 100 mg and 200 mg (Prometrium) (Progestogen alone)
2. Estradiol gel, for topical use (Divigel) (Systemic estrogen alone)
3. Synthetic conjugated estrogens, A tablets for oral use (Cenestin) (Systemic estrogen alone)
4. Synthetic conjugated estrogens, B tablets for oral use (Enjuvia) (Systemic estrogen alone)
5. Estradiol vaginal system (Estring) (Topical vaginal estrogen)
6. Estradiol and progesterone capsules for oral use (Bijuva) (Systemic estrogen and progestogen)

This action was initiated by the FDA in November 2025 following a comprehensive review of the scientific literature on the safety of HRT.³ Since that announcement, 29 companies have submitted proposed labeling changes. The 6 approved today reflect the first batch of labeling updates to align with the scientific evidence.

“With today’s action, we are delivering on our promise to make sure women have accurate, scientifically grounded information about the potentially life-changing benefits of HRT,” said FDA Commissioner Marty Makary, MD, MPH, in the agency’s new release.¹ “Women face symptoms of menopause that can last for years, and our efforts will help these women make well-informed medical decisions.”

In the news release, the agency cited data from randomized studies showing that women who initiate HRT within 10 years of the onset of menopause (generally before age 60) have a reduction in all-cause mortality and fractures. Despite these benefits, only a small proportion of eligible patients use HRT. The agency noted that in 2020, there were 41 million women in the US aged 45 to 64, yet only about 2 million women aged 46 to 65 received a prescription for HRT. 

“This decision reflects our commitment to follow the science wherever it leads and to correct course when the evidence demands it,” added Health and Human Services Secretary Robert F. Kennedy, Jr., in the news release.¹ “By removing these boxed warnings, we ensure that women receive accurate information about hormone therapy—free from exaggeration or fear. A health care 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.”

REFERENCES

1. FDA Approves Labeling Changes to Menopausal Hormone Therapy Products. News release. Us Food & Drug Administration. February 12, 2026. Accessed February 12, 2026. https://www.fda.gov/news-events/press-announcements/fda-approves-labeling-changes-menopausal-hormone-therapy-products

2. Menopausal Hormone Therapies with Updated Prescribing Information. US Food & Drug Administration. Accessed February 12, 2026. https://www.fda.gov/drugs/drug-safety-and-availability/menopausal-hormone-therapies-updated-prescribing-information

3. HHS Advances Women’s Health, Removes Misleading FDA Warnings on Hormone Replacement Therapy. News release. US Food & Drug Administration. November 10, 2025. Accessed February 12, 2026. https://www.fda.gov/news-events/press-announcements/hhs-advances-womens-health-removes-misleading-fda-warnings-hormone-replacement-therapy-0