Risk statements involving cardiovascular disease, breast cancer, and probable dementia are no longer included in the boxed warning for select menopausal hormone therapies.
The US Food and Drug Administration (FDA) has approved labeling changes to six menopausal hormone therapy products after a comprehensive review of the scientific literature, removing specific risk statements from the boxed warning, the agency’s most prominent safety-related warning.
The FDA initiated the labeling updates in November 2025 and requested proposed revisions from 29 drug manufacturers. The first six approved products span four categories of menopausal hormone therapy: systemic combination therapy with estrogen and progestogen; systemic estrogen-alone therapy; systemic progestogen-alone therapy in women with a uterus using systemic estrogen; and topical vaginal estrogen therapy.
In a statement accompanying the announcement, Health and Human Services Secretary Robert F. Kennedy, Jr., stated “This decision reflects our commitment to follow the science wherever it leads and to correct course when the evidence demands it.” FDA Commissioner Marty Makary, MD, MPH, stated, “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.”
Menopause is a typical stage of life; however, associated symptoms can significantly affect quality of life. Common symptoms include hot flashes and night sweats, known as vasomotor symptoms, along with vaginal, vulvar, and urinary tract changes linked to lower estrogen levels. Bone loss leading to osteoporosis and increased fracture risk is also associated with menopause.
The FDA has approved several hormone therapy options for moderate to severe hot flashes, vaginal dryness and discomfort, and the prevention of bone loss. Randomized studies have demonstrated that women who initiate hormone therapy within 10 years of menopause onset, generally before age 60 years, experience reductions in all-cause mortality and fractures.
Use of hormone therapy remains low among women who may benefit. In 2020, approximately 41 million US women were aged 45 to 64 years, yet only about 2 million women aged 46 to 65 years received a prescription for hormone therapy.
Source: FDA
