FDA drops top warnings on 3 menopause patches without outside advisers

The US Food and Drug Administration (FDA) said on Friday that three more estrogen patches used to treat menopause symptoms will no longer carry black-box warnings about heart and blood vessel disease, breast cancer and dementia¹. A black-box warning is the strongest safety warning the FDA can put on a prescription drug, shown inside a bold black border on the label².

As with earlier changes, the agency did not call one of its outside advisory committees, the independent expert panels it can ask to review a decision. It also gave few details on the science behind the move at its press briefing¹. When reporters asked for the evidence, officials said it could be provided later¹. The reports did not name the three patches.

What the FDA announced

This is the second batch of menopause hormone products to lose these boxed warnings. In February, the FDA approved label changes for six menopausal hormone therapy products, removing the boxed risk statements on cardiovascular disease, breast cancer and probable dementia³. At the time, the agency said those six were only the first batch, and that 29 drug companies had submitted proposed label changes³.

Sarah Ibrahim, a deputy center director at the FDA’s drug center, said the agency is also working to change the labels of the remaining menopause hormone products¹. In a press release on Friday, the FDA also said it is exploring whether vaginal estrogen products could be sold over the counter, without a prescription¹.

How the warnings got there, and how they started coming off

The warnings trace back to the Women’s Health Initiative (WHI), a large US study whose early-2000s findings reported higher risks of breast cancer, blood clots, heart attack and stroke in women using certain hormone therapies². Those results led millions of women to stop treatment².

The current changes began with an FDA panel in July 2025, where experts called for new labels³. The FDA started the removal process in November 2025³. On November 12, the FDA Commissioner and staff from the agency’s drug center held a public call about the decision⁴.

The agency skipped its advisory committees then too. A spokesperson said at the time that the committees are “bureaucratic, long, often conflicted, and very expensive”¹.

When the first six labels changed in February, Health and Human Services Secretary Robert F. Kennedy Jr. said the decision reflected a “commitment to follow the science wherever it leads”³. FDA Commissioner Marty Makary said the changes would help people facing menopause “make well-informed medical decisions”³.

What the FDA says the evidence shows

Ibrahim said the boxed warnings “painted a broad and, in some cases, overstated pictures of risk”¹. She added:

“Updated evidence shows that for many healthy women under 60 and within 10 years of menopause onset, the risk-benefit profile looks meaningfully different than older warnings conveyed.”¹

A similar view appears in some doctors’ guidance. A patient explainer from Jackson Health System, a Miami hospital network, says many WHI participants were older than the typical woman starting hormones, and that later studies found lower risks in younger, healthier women². The same explainer notes that risks still vary by age, health history and type of therapy².

Patches deliver estradiol, a form of estrogen, through the skin. They are usually considered lower risk than synthetic pills because the hormone reaches the bloodstream without passing through the liver first¹. Research shows the risks of patches are higher at high doses¹.

Patches were notably missing from February’s first batch. Nanette Santoro, an obstetrics and gynecology professor at the University of Colorado, said then that she was surprised skin estradiol was left out, since most guidelines worldwide favor non-oral estrogen³. She noted that this preference rests on observational studies (studies that track people rather than test a treatment against a dummy), not necessarily on clinical trial data³.

Why some experts object to the process

The main complaint is about how the decision was made, not only what it says. “I have been concerned by the lack of transparency behind these decisions,” said Reshma Ramachandran, an assistant professor and health services researcher at Yale School of Medicine¹. She said the blanket removal of warnings about breast cancer and cardiovascular disease “without clear justification can be misleading for patients and underplays real potential harms”¹. She pointed to particular risks for some groups, such as people with a history of hormone-sensitive cancers¹.

Ramachandran also criticized the July 2025 panel. She said it featured doctors and influencers who were all vocal supporters of menopause hormone therapy, several of whom had conflicts of interest with practices that market and sell it¹. She said the meeting did not allow public testimony, including from the lead investigator of the WHI, who was in the audience¹. After audience members raised concerns, the FDA opened a docket for public comment¹.

Menopause experts have also said officials in the Trump administration made sweeping and “data-free” claims about the benefits of hormone therapy, including better longevity, that research does not support¹. They said the treatments do benefit some women, but that skipping advisers and not sharing research sets a troubling precedent¹.

Not all doctors see a problem. In February, Holly Thacker, who directs the Cleveland Clinic Center for Specialized Women’s Health, praised the change as “in line with the published research and is evidence based”³. She said she hoped it would reduce “exaggerated fear” that kept women from taking hormones and doctors from prescribing them³. Santoro, by contrast, said she was unsure the label changes would affect patients much, since she believes most do not read the safety labels³.

Patients face patch shortages

At Friday’s briefing, officials focused on shortages¹. Ibrahim said that after the February label changes, demand for estradiol patches “increased significantly, and patients in many areas found it difficult to get their usual patches at their usual pharmacy”¹.

Dorothy Fink, deputy director of the National Institute of Child Health and Human Development, said officials are “working with manufacturers to strengthen supply and improve access”¹. She said manufacturing of estrogen patches has doubled over the past year¹. Patients still report stock-outs¹.

What this decision does not show

This is a change to the wording on drug labels. It does not come with new study results, and the FDA has not yet released the evidence it relied on¹. A few points remain open:

• Which data the agency used. Officials said the evidence could be provided later, but no date was given¹.
• Who the change applies to. The FDA’s own reasoning focuses on many healthy women under 60 and within 10 years of menopause¹. Critics say some groups, such as people with hormone-sensitive cancers, face particular risks¹.
• Dose matters. Research shows patch risks rise at high doses, a detail a boxed warning would not capture either way¹.
• Other risks on the label. In February, Santoro questioned what data supported the label wording on blood clot risk for combined estrogen and progestin products³.

The decision does not say hormone therapy is safe or unsafe for any one person. It removes the most prominent warning box; the change in February removed specific risk statements from that box³.

What to watch next

Three things are worth following. First, whether the FDA publishes the evidence behind Friday’s decision, as officials said it could¹. Second, label changes for the remaining menopause hormone products, which the agency says it is working on¹, out of the proposals from 29 companies³. Third, whether vaginal estrogen moves toward over-the-counter sale, which the FDA says it is exploring¹. Supply of patches, and whether doubled manufacturing ends the stock-outs patients report, is the near-term issue for people already using them¹.