FDA Removes More Estrogen Patch Boxed Warnings

FDA has approved revised labeling for three additional estradiol transdermal patch products, removing boxed-warning statements about cardiovascular disease, breast cancer and probable dementia, HHS announced 10/30, prompting renewed criticism over the agency's decision to proceed without a formal advisory committee meeting or publicly presenting detailed scientific evidence supporting the changes. 

The latest move expands FDA's earlier action to revise menopausal hormone therapy labeling, following approvals of similar changes for six products in February (see earlier story). According to HHS, 29 drug companies have submitted proposed labeling revisions in response to the initiative. The department did not identify the three newly affected patch products.

FDA said the changes reflect a reassessment of the scientific literature and the benefit-risk profiles of hormone therapies. Agency officials said older Boxed Warnings overstated risks for many healthy women younger than 60 or within 10 years of menopause onset. 

However, the agency did not convene a formal advisory committee to consider the latest changes and provided few details about the underlying evidence during its announcement, according to The Guardian. Officials reportedly told journalists that supporting evidence could be provided later. 

Yale School of Medicine assistant professor and health services researcher Reshma Ramachandran told The Guardian she was concerned about the lack of transparency surrounding the decisions. She warned that removing broad Boxed Warnings without clearly explaining the scientific justification could mislead patients and minimize potential harms, particularly among women with histories of hormone-sensitive cancers. 

The controversy also extends to FDA's earlier decision-making process. Rather than convening a traditional advisory committee, the agency held an expert panel in 7/2025 that included hormone therapy proponents, some with financial interests in related medical practices. Ramachandran criticized the absence of public testimony at that meeting. FDA subsequently opened a public docket for comments. 

FDA has previously indicated that the Boxed Warning concerning endometrial cancer would remain for systemic estrogen-alone products. 

Separately, HHS reported that manufacturers of estradiol patches have doubled overall market output during the past 12 months amid growing demand and concerns about product availability.

FDA also said it is exploring potential over-the-counter availability of vaginal estrogen products, which are used to treat certain menopausal symptoms.