FDA changes labels on three common menopause treatments after previously updating six others: ‘…concerned by the lack of transparency’
Misleading patients?
The U.S. Food and Drug Administration (FDA) has updated the labels for three more menopausal hormone therapy products, effectively removing black-box warnings regarding cardiovascular disease, breast cancer, and dementia. According to The Guardian, this action, confirmed on October 30, 2026, by the U.S. Department of Health and Human Services (HHS), follows a similar move earlier in February 2026 that affected six other treatments.
Contemporary OB/GYN reports that all three of these latest products are estradiol transdermal patches. The FDA did not name the specific brands or manufacturers involved in this most recent update.
This decision comes as the agency moves forward with its broader initiative to adjust labeling for hormone therapies. Since the FDA began reaching out to companies about these changes in November 2025, a total of 29 drug companies have submitted proposals for new labels. These regulatory shifts align with the executive order titled ‘Advancing Women’s Health to Improve Outcomes in All Phases of Life’, which was signed on October 19, 2026.
The process has sparked significant debate among medical professionals and researchers
The FDA chose not to convene an advisory committee to discuss the scientific evidence supporting the removal of these warnings. When reporters requested the data behind this decision during a press briefing, officials indicated that the information could be provided at a later time.
Reshma Ramachandran, an assistant professor and health services researcher at Yale School of Medicine, voiced strong disapproval regarding the lack of public involvement. “I have been concerned by the lack of transparency behind these decisions,” she said.
Ramachandran further noted that the broad removal of these warnings without clear justification could be misleading for patients. She emphasized that specific groups, such as those with histories of hormone-sensitive cancers, still face particular risks that should not be ignored.
The FDA has defended its stance
It suggests that previous warnings overstated risks for certain groups. Sarah Ibrahim, deputy center director for regulatory programs of the FDA’s Center for Drug Evaluation and Research, stated that the black-box warnings “painted a broad and, in some cases, overstated pictures of risk”. She added that updated evidence suggests the risk-benefit profile for healthy women under 60 who are within 10 years of menopause onset looks meaningfully different than what older warnings conveyed.
Estradiol patches are often viewed as lower risk than synthetic oral medications, primarily because they enter the bloodstream without passing through the liver first. However, research indicates that these risks rise when patients use higher doses. Experts have pointed out that the FDA previously bypassed advisory committees in November 2025 by claiming such groups are “bureaucratic, long, often conflicted, and very expensive”.
Instead of traditional advisory panels, the FDA held a meeting in July 2025 that included doctors and influencers who are vocal supporters of menopausal hormone therapy. Ramachandran pointed out that several of these individuals had conflicts of interest related to practices that market and sell these treatments. She also noted that the agency did not permit public testimony during this meeting, even though the lead investigator of the Women’s Health Initiative was present.
Patients have been struggling to find these patches at pharmacies
The push for these label changes is happening alongside a persistent struggle for patients to find these patches at pharmacies. While the FDA acknowledged in September that patients were facing difficulties, it has stopped short of officially declaring a nationwide shortage. In the October 30, 2026, announcement, the agency stated that it is in close contact with manufacturers and is not aware of an imminent risk of a nationwide shortage.
The FDA claims that production efforts have doubled market output over the past 12 months. Manufacturers have reportedly expanded capacity and added shifts to handle the increased demand. Ibrahim noted that after the February changes, demand for estradiol patches grew significantly, making it difficult for many people to access their usual treatments. The agency is now working with manufacturers to address these access challenges.
Susan Reed, a professor emeritus at UW Medicine, stated, “I am glad to see the lifting of black box warnings on these transdermal estrogen products.” She noted that the pendulum has swung significantly in recent years. Reed believes that clinicians must now take on more responsibility in counseling patients.
She suggested that careful shared decision-making is more important than before. According to Reed, doctors must consider if these products are safe for women starting them over the age of 60 and whether risks should be mentioned when patches are taken alongside oral progestogens.
The FDA is also working to approve generic hormone therapy products. Furthermore, it is exploring the possibility of making vaginal estrogen products available over the counter. Any transition to over-the-counter status would require formal FDA approval. For now, the agency continues to monitor the supply of various dosage forms including gels and creams as it updates labels for the remaining products.
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