The Food and Drug Administration on Wednesday approved labeling changes for six menopausal hormone therapy products, a move intended to clarify the risks associated with the treatments and encourage more informed discussions between women and their doctors.
The revisions remove risk statements related to cardiovascular disease, breast cancer, and probable dementia from the “boxed warning” sections of the product labels. This action, initiated in November 2025, represents the first major reassessment of hormone replacement therapy (HRT) safety in over two decades, according to the FDA.
“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 statement. “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.”
Menopause, even as a natural transition, can cause significant discomfort for many women, including hot flashes, night sweats, vaginal dryness, and an increased risk of osteoporosis. The FDA has approved hormone therapies to address moderate-to-severe symptoms and to prevent bone loss. Recent studies suggest that women who begin HRT within ten years of menopause – typically before age 60 – may experience a reduction in all-cause mortality and fractures, yet uptake of these treatments remains relatively low.
The warning regarding endometrial cancer will remain on labels for systemic estrogen-alone therapies.
The six products with approved labeling changes span the four main categories of HRT:
- Systemic combination therapy (estrogen and progestogen): Bijuva (TherapeuticsMD, Inc)
- Systemic estrogen-alone therapy: Divigel (Upsher-Smith Laboratories), Cenestin (Avion Pharmaceuticals), and Enjuvia (Duramed Pharmaceuticals)
- Systemic progestogen-alone therapy: Prometrium (Acertis Pharmaceuticals), for use with systemic estrogen in women with a uterus
- Topical vaginal estrogen therapy: Estring (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,” FDA Commissioner Marty Makary, MD, MPH, said in the agency’s release. “Women face symptoms of menopause that can last for years, and our efforts will help these women make well-informed medical decisions.”
The FDA indicated that additional labeling changes for other menopausal hormone therapy products are expected to follow.
