FDA Removes Boxed Warnings on Cardiovascular, Cancer, and Dementia Risks From Select Menopausal Hormone Therapy Labels

The US Food and Drug Administration (FDA) has approved labeling changes for six menopausal hormone therapy (MHT) products, removing risk statements related to cardiovascular disease, breast cancer, and probable dementia from the boxed warning—the agency’s most prominent safety warning. The changes follow a comprehensive review of the scientific literature initiated by the FDA in November 2025.

The labeling updates apply to products across 4 categories of hormone therapy for menopausal women:

• Systemic combination therapy (estrogen and progestogen)
• Systemic estrogen-alone therapy
• Systemic progestogen-alone therapy for women with a uterus using systemic estrogen
• Topical vaginal estrogen therapy

According to the FDA, 29 drug companies submitted proposed labeling revisions at the agency’s request. The six products approved to date represent the first group to receive updated labeling.

“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 FDA 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.”

FDA Commissioner Marty Makary, MD, MPH, added: “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. 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 normal physiologic transition, but symptoms can significantly impair quality of life. Common manifestations include vasomotor symptoms such as hot flashes and night sweats, genitourinary syndrome of menopause (including vaginal dryness and urinary tract changes), and bone loss leading to increased fracture risk. The FDA has approved multiple hormone therapies for moderate-to-severe vasomotor symptoms, vaginal symptoms, and prevention of bone loss.

The agency noted that randomized studies show women who initiate hormone therapy within 10 years of menopause onset—generally before age 60 years—experience reductions in all-cause mortality and fractures. Despite these potential benefits, use remains limited. 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 hormone therapy prescription.

The FDA stated that the updated labeling is intended to provide clearer, evidence-based risk information to support shared decision-making between women and their clinicians. Women are encouraged to consult the updated drug labels for detailed information regarding benefits and risks.

Additional labeling updates are expected as the FDA continues reviewing submissions from other manufacturers.

Reference

1. US Food and Drug Administration. FDA approves labeling changes to menopausal hormone therapy products. News release. February 12, 2026.