US to drop boxed warnings from three more menopause patches
The Food and Drug Administration (FDA) said on October 30, 2026, that three more menopause patches will no longer carry black-box warnings about cardiovascular disease, breast cancer and dementia. The Guardian
Black-box warnings are the boxed alerts printed on some drug labels. The FDA did not convene an advisory committee, a panel of outside experts, before making the decision. Reuters reported the same day that the U.S. Health Department would remove the broad black-box warning from three estrogen patch products. Reuters
The change follows a series of earlier steps. In November 2025, the FDA announced it was starting to remove black-box warnings from all menopausal hormone therapy products. In February 2026, it approved labeling changes to six such products. FDA
At the press briefing, FDA officials offered few details on the scientific basis for removing the warnings from the three patches. When journalists asked for the evidence behind the decision, officials said it could be provided later.
Sarah Ibrahim, deputy center director for regulatory programs at the FDA's Center for Drug Evaluation and Research, said the black-box warnings painted a broad and, in some cases, overstated picture of risk. Reshma Ramachandran, an assistant professor and health services researcher at Yale School of Medicine, said that removing warnings across the board without clear justification can be misleading and underplays harms.
Supply is another part of the picture. Ibrahim said that after the February label change, demand for estradiol patches, a type of estrogen patch, increased significantly, and patients in many areas found it difficult to get their usual patches. 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.
The FDA said it is working with manufacturers to ramp up production of estrogen patches. It also said it is working to change the labels of the remaining menopause hormone treatment products.
