Women seeking estrogen patches for menopause are confronting changing safety labels while many are still unable to fill their prescriptions.
The Food and Drug Administration said the previous black-box warnings gave an overly broad account of risk in some cases, and that newer evidence changes the balance of benefits and risks for many healthy women under 60 who are within 10 years of menopause onset.
On Friday, the FDA said it would remove black-box warnings concerning cardiovascular disease, breast cancer and dementia from three estrogen patches used for menopause. The agency did not convene an advisory committee before making the decision.
It is the second major removal of such warnings without the agency’s usual outside advisory process. The FDA removed warnings from six menopause treatments in February, after also bypassing its committees last November.
At the time, an FDA spokesperson described the committees as ‘bureaucratic, long, often conflicted, and very expensive.’
When journalists asked FDA officials for the evidence supporting the latest action, they said it could be provided later.
Reshma Ramachandran, an assistant professor and health services researcher at Yale School of Medicine, said she was troubled by the process. ‘I have been concerned by the lack of transparency behind these decisions,’ she said.
She said: ‘The blanket removal of black-box warnings regarding risks of breast cancer and cardiovascular disease without clear justification can be misleading for patients and underplays real potential harms.’
The agency had held an expert panel in July 2025 featuring doctors and influencers who supported menopause hormone therapy. Ramachandran said the meeting ‘did not allow for public testimony,’ including from the lead investigator of the Women’s Health Initiative, who was in the audience.
Sarah Ibrahim, deputy centre director for regulatory programmes at the FDA’s Center for Drug Evaluation and Research, said demand for estradiol patches rose sharply after the February label changes. Patients in many areas then struggled to find their usual patches at their regular pharmacies, she said.
Prescription demand rose by more than 160% in the last two years, according to HealthVerity data. Prescriptions for estrogen patches increased from 594,000 in June 2024 to 1.6 million in May.
In Charlotte, Nicole Bentivegna, a certified nurse practitioner at Signature Wellness, assigned two medical assistants full-time to call pharmacies across every ZIP code served by the practice in search of available patches.
Dr Claire Bowles, medical director of Novant Health’s Pelvic Health and Menopause Care, said hormone replacement therapy can reduce longer-term risks of cardiovascular disease and osteoporosis. She said stopping treatment without a transition can bring severe symptoms quickly, including sleep problems, mood changes, anxiety and heart palpitations.
Manufacturers have doubled production capacity, and the FDA has expedited manufacturing supplements, yet patients around the country have continued to report increasing difficulty getting their prescriptions filled.
The FDA has not formally classified estradiol as being in a national shortage. In August, Democratic House lawmakers wrote to the agency urging it to put estradiol on the federal drug-shortage list.
Jackie Speier, a San Mateo County Supervisor, also wrote to members of Congress seeking an official shortage declaration for estradiol transdermal patches. She said women should not have to struggle for estrogen prescriptions or search for alternatives, and said the FDA needed to meet demand for a medicine used by millions of women in their mid-40s and 50s.
Kyle Diamantas, the acting FDA commissioner, said: ‘FDA’s actions today are grounded in, and consistent with, a sustained commitment to women’s health as a cross-cutting agency priority.’
He said the agency was also committed to ensuring women could obtain hormone therapy when they and their doctors decided it was appropriate.
The FDA is exploring whether vaginal estrogen products could be made available over the counter.
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