On Feb. 12, the U.S. Food and Drug Administration approved labeling changes for six menopausal hormone therapy products to clarify risk considerations and remove outdated warnings.

Risk statements related to cardiovascular disease, breast cancer and probable dementia were eliminated from the “boxed warning,” the agency’s strongest safety alert according to a news release.

“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 the 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.”

The FDA began the process in November 2025, reviewing scientific literature and requesting proposed labeling updates from 29 drug companies. The first group of approved changes covers six products representing the four main categories of hormone replacement therapy for menopausal women: systemic combination therapy with estrogen and progestogen, systemic estrogen-alone therapy, systemic progestogen-alone therapy for women with a uterus using systemic estrogen, and topical vaginal estrogen therapy.

“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, M.D., M.P.H., said. “Women face symptoms of menopause that can last for years, and our efforts will help these women make well-informed medical decisions.”

Menopause is a natural stage of life, but its symptoms can reduce quality of life. Common issues include hot flashes and night sweats, known as vasomotor symptoms; vaginal, vulvar and urinary tract changes caused by declining estrogen; and osteoporosis, which increases fracture risk.

The FDA has approved multiple hormone therapies to treat moderate-to-severe hot flashes, vaginal dryness and discomfort, and prevent bone loss. Research shows that women who begin HRT within 10 years of menopause, generally before age 60, may experience reductions in all-cause mortality and fractures. Despite the benefits, only a small portion of women who could benefit are using these treatments. In 2020, about 41 million U.S. women were ages 45–64, yet only around 2 million women ages 46-65 received hormone therapy prescriptions.

The agency said the labeling changes will help women work with their health care professionals to make informed decisions about treatment. Updated drug information is available at www.fda.gov.