FDA approves labeling changes for six menopausal hormone therapy products
The US Food and Drug Administration (FDA) announced on Thursday that it has approved updates to the labeling of six hormone replacement therapy (HRT) products used to treat menopause. These updates include the removal of boxed warnings concerning cardiovascular diseases, breast cancer, and probable dementia associated with the use of these therapies.Efforts to remove the "black box" warnings began in November when the FDA announced plans to eliminate these warnings to improve women's access to these treatments. (RELATED: FDA to remove boxed warnings from hormone therapies for menopause, Regulatory Focus 10 November 2025)
FDA said 29 drug companies have submitted proposed labeling changes for six products. These products are from each of the four categories of HRTs for menopausal women. These include systemic combination therapies such as estrogen and progestogen, systemic estrogen-alone therapy, systemic progestogen-alone therapy for women with a uterus using systemic estrogen, and topical vaginal estrogen therapy.
The updated information will apply to the following products:
- Progestogen alone: Prometrium
- Systemic estrogen alone: Divugel, Cenestin, Enjuvia
- Topical vaginal estrogen: Estring
- Systemic estrogen and progestogen: Bijuva
“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 in a statement accompanying the announcement. “Women face symptoms of menopause that can last for years, and our efforts will help these women make well-informed medical decisions.”
These black box warnings were prompted by a 2002 National Institutes of Health (NIH) Women’s Health Initiative (WHI) study, which linked combined hormone replacement therapy (HRT) to increased risks of heart disease, stroke, and breast cancer. As a result of the study's publication, the number of women opting for these treatments fell dramatically. The study was largely discredited because it focused on a narrow segment of women using HRTs, failing to consider the broader population of HRT users.
A July 2025 advisory committee panel convened by FDA Commissioner Makary dismissed the 2002 study and recommended lifting these black box warnings. (RELATED: Panel urges FDA to remove boxed warning on women’s hormone therapy, Regulatory Focus 17 July 2025)
The agency noted that randomized studies show women who start HRT within 10 years of the onset of menopause, typically before age 60, experience reductions in all-cause mortality and fractures.
Despite these benefits, the FDA said that “just a small fraction of women who could benefit from these treatments, however, are using them. In 2020, about 41 million U.S. women were ages 45–64 — yet only about 2 million women ages 46–65 received a hormone-therapy prescription.”
Announcement
×
Welcome to the new RAPS Digital Experience
We have completed our migration to a new platform and are pleased to introduce the updated site.
What to expect: If you have an existing login, please RESET YOUR PASSWORD before signing in. After you log in for the first time, you will be prompted to confirm your profile preferences, which will be used to personalize content.
We encourage you to explore the new website and visit your updated My RAPS page. If you need assistance, please review our FAQ page.
We welcome your feedback. Please let us know how we can continue to improve your experience.