FDA Approves Drug Labeling Changes to 6 Menopausal Hormone Therapy Products

The FDA approved drug labeling changes to 6 menopausal hormone therapy products, also known as hormone replacement therapy (HRT), to clarify risk considerations for these drugs. This action aims to encourage women to work with their health care professionals to make better-informed decisions about their treatment plan for menopause and related symptoms.¹

“This decision reflects our commitment to follow the science wherever it leads and to correct course when the evidence demands it,” Health and Human Services Secretary Robert F. Kennedy Jr, said in a news release. “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.”¹

Although menopause is a normal stage in life, its symptoms can significantly reduce quality of life. Common symptoms include vasomotor symptoms, or hot flashes and night sweats; vaginal, vulvar, and urinary tract changes caused by lower estrogen levels; and osteoporosis, which increases the risk of fractures.¹

The FDA has approved multiple hormone therapies for moderate-to-severe hot flashes, vaginal dryness and discomfort, and preventing bone loss. Additionally, randomized studies demonstrate that women who initiate HRT within 10 years of the onset of menopause—which is most commonly before 60 years of age—have a reduction in all-cause mortality and fractures; however, a relatively small number of individuals who could benefit from these treatments are using them.¹

What Do the Approved Label Changes Address?

The label changes approved by the agency approved risk statements related to cardiovascular disease, breast cancer, and probable dementia were removed from the respective products’ boxed warning sections. These removals, which were initiated in November 2025, followed a comprehensive review of scientific literature and represented the first major reassessment of HRT safety in more than 2 decades.^1,2 Despite the removal, the warning for endometrial cancer will remain on systemic estrogen-alone therapies.²

According to the FDA, this first batch of 6 products with approved labeling changes includes products from each of the 4 categories of HRT for menopausal women^1,3:

• systemic combination therapy (estrogen and progestogen), such as Bijuva (TherapeuticsMD, Inc);
• systemic estrogen-alone therapy, such as Divigel (estradiol gel; Upsher-Smith Laboratories), Cenestin (synthetic conjugated estrogens, A; Avion Pharmaceuticals), and Enjuvia (synthetic conjugated estrogens, B; Duramed Pharmaceutcials);
• systemic progestogen-alone therapy, such as Prometrium (progesterone, USP; Acertis Pharmaceuticals), for women with a uterus using systemic estrogen; and
• topical vaginal estrogen therapy, such as Estring (estradiol vaginal system; Pfizer).

“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,” Marty Makary, MD, MPH, FDA Commissioner, said in the news release. “Women face symptoms of menopause that can last for years, and our efforts will help these women make well-informed medical decisions.”¹

REFERENCES

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

2. Gerlach A. FDA Removes Black Box Warning From Hormone Therapies for Menopause. Pharmacy Times. November 10, 2025. Accessed February 12, 2026. https://www.pharmacytimes.com/view/fda-removes-black-boxed-warning-from-hormone-therapies-for-menopause

3. Menopausal Hormone Therapies with Updated Prescribing Information. FDA. Updated February 12, 2026. Accessed February 12, 2026. https://www.fda.gov/drugs/drug-safety-and-availability/menopausal-hormone-therapies-updated-prescribing-information