• Analysis
FDA removes black-box warnings from three more menopause hormone therapy patches
FDA officials said on Friday that three more menopause treatment patches will no longer carry black-box warnings about cardiovascular disease, breast cancer and dementia, without convening an advisory committee and with few details given on the scientific basis.
Second round of warning removals
The latest move on FDA black-box warnings for menopause products came on Friday, when officials said three more treatment patches would drop the boxed alerts covering cardiovascular disease, breast cancer and dementia. It follows February's decision to strip the warnings from six menopause treatments, a change that arrived while patients across the US faced shortages of the patches.
As before, the agency did not bring in an advisory committee and shared little about the science at its briefing. When journalists asked for the evidence behind the decision, officials said it could be provided later.
- •The boxed warnings covered cardiovascular disease, breast cancer and dementia.
- •Six menopause treatments lost their warnings in February.
- •Officials said evidence behind the decision could be provided later.
Experts raise transparency concerns
Reshma Ramachandran, who works as an assistant professor and health services researcher at Yale School of Medicine, told reporters these decisions worry her because of how little about them is made public. In her view, taking the breast cancer and cardiovascular alerts off every label at once, with no clear justification laid out, risks misleading patients and playing down genuine potential harms.
There are particular risks for certain groups of patients, such as those with histories of hormone-sensitive cancers
She pointed to groups the blanket approach does not account for, among them patients who have previously had hormone-sensitive cancers.
FDA's case for the change
Sarah Ibrahim, deputy center director for regulatory programs at the FDA's Center for Drug Evaluation and Research, told the briefing that the old warnings "painted a broad and, in some cases, overstated pictures of risk".
- •Ibrahim said newer evidence, on her account, gives many healthy women a different risk-benefit picture from what the older warnings suggested - specifically those under 60 who are within 10 years of menopause onset.
- •The FDA first went around its advisory committees in November when it announced the removals; a spokesperson at the time called the committees "bureaucratic, long, often conflicted, and very expensive".
- •In place of advisers, the agency gathered a panel in July 2025 of doctors and influencers who were vocal MHT proponents - several of whom, Ramachandran said, had conflicts of interest with practices that market and sell hormone therapy.
Shortages and supply efforts
Ibrahim said demand for estradiol patches rose sharply after February's label change, and that in many areas patients could not get their usual patches at their usual pharmacy. "We know that for some patients, these past months have been frustrating," she said.
Dorothy Fink, deputy director of the National Institute of Child Health and Human Development, said manufacturing of estrogen patches has doubled over the past year. "We are working with manufacturers to strengthen supply and improve access," she said.
The FDA says it is working with manufacturers to ramp up production and change the labels of the remaining MHT products. According to a Friday agency press release, it is also exploring the possibility of offering vaginal estrogen products over the counter.
