The warnings cover cardiovascular disease, breast cancer and dementia. The FDA did not convene advisers or present detailed evidence for its October 30 decision, but says it can provide the evidence later.
On 30 October, US Food and Drug Administration officials said three more estrogen patches used to treat menopause would lose boxed warnings about cardiovascular disease, breast cancer and dementia. Boxed warnings are prominent safety notices on drug labels. The decision follows the removal of boxed warnings from six menopause treatments in February 2026, according to The Guardian.
The FDA did not convene an advisory committee for the October decision and gave few details about its scientific basis at the briefing. Asked for the evidence, officials said they could provide it later.
Analysis
Sarah Ibrahim, an FDA regulatory official, said the warnings gave an overly broad picture of risk. She said updated evidence points to a different balance of risks and benefits for many healthy women under 60 who are within 10 years of menopause onset. Estradiol patches deliver medication into the bloodstream without first passing through the liver and are usually considered lower risk than synthetic oral medications. Research indicates that risks rise with higher patch doses.
Reshma Ramachandran, a health services researcher at Yale School of Medicine, said removing breast cancer and cardiovascular warnings without clear justification could mislead patients about potential harms. She identified people with histories of hormone-sensitive cancers as a group facing particular risks.
The Women’s Health Initiative included randomized trials designed to examine cardiovascular disease, cancer and osteoporosis in postmenopausal women. Its findings have been criticized for being communicated without enough distinction between women in their 50s and a study population weighted toward women aged 60 or older.
Its 2026 report attributes more than 70% of those estimated deaths to human-caused climate change and estimates $1.07 trillion in potential income losses from heat in 2025, adding to its call for a coordinated health response.
The FDA also bypassed its advisory committees when it announced warning removal in November 2025. A spokesperson said then that the committees were bureaucratic, lengthy, often conflicted and expensive. Ramachandran said a panel the agency convened in July 2025 included proponents of menopause hormone therapy, several with interests in practices that sell it, and did not allow public testimony. After audience members raised concerns, the FDA opened a public-comment docket.
Research from the Women’s Health Initiative informed menopause hormone therapy recommendations. Ramachandran said its lead investigator was in the audience at the July panel but could not give public testimony.
Ibrahim said demand for estradiol patches rose significantly after February’s label changes, and patients in many areas had trouble finding their usual patches at their usual pharmacy. Dorothy Fink, deputy director of the National Institute of Child Health and Human Development, said estrogen patch production had doubled over the past year and officials were working with manufacturers to improve supply. Patients have reported patch stock-outs.
Ibrahim said the FDA was working with manufacturers to increase production and was pursuing label changes for the remaining menopause hormone therapy products. The agency is also exploring whether vaginal estrogen products could be offered without a prescription.
3 min
Among participants who stayed on treatment, Lilly says its highest retatrutide dose reduced A1c by 2.2 percentage points versus 1.8 for Ozempic after 80 weeks, and weight by 20.9% versus 9.4%. The results describe that group, not everyone enrolled.
1 min
The review warns that reversing nature loss and meeting 23 targets by 2030 require rapidly accelerated action. Countries also agreed a voluntary route for additional donors to signal interest before COP18, while leaving the form of a post-2030 financial mechanism for that conference in 2028.
3 min
