FDA Strips Black-Box Warnings From Three More Menopause Patches as Women Struggle to Find Supply

WASHINGTON, Oct. 30 (TodayViralUSA) — The Food and Drug Administration on Friday removed its most serious “black box” warnings from three more estrogen patches used to treat menopause symptoms, extending a policy shift that began earlier this year even as many women report trouble finding the patches at their pharmacies.

The agency approved updated labels for three estradiol transdermal patches from two manufacturers, dropping boxed statements about cardiovascular disease, breast cancer and probable dementia. The Department of Health and Human Services said the move follows similar label changes for six menopausal hormone therapy products in February and supports an executive order on women’s health that President Donald Trump signed on Oct. 19.

Why the FDA says the warnings changed

The boxed warnings, which date to the early 2000s, “painted a broad and, in some cases, overstated picture of risk,” Sarah Ibrahim, a deputy center director at the FDA’s Center for Drug Evaluation and Research, told reporters. “Updated evidence shows that for many healthy women under 60 and within 10 years of menopause onset, the risk-benefit profile looks meaningfully different than older warnings conveyed,” she said, according to The Guardian.

HHS said 29 drug companies have now submitted proposed labeling changes for hormone therapy products and that the FDA is working through them. The agency is also exploring whether vaginal estrogen products could be sold over the counter.

Supply strains

Demand for estradiol patches rose sharply after the February label changes, and patients in many areas have struggled to fill prescriptions. “We know that for some patients, these past months have been frustrating,” Ibrahim said. HHS said all six makers of FDA-approved estradiol patches have expanded capacity and added shifts, roughly doubling market output over the past 12 months. The FDA said it is not aware of an imminent risk of a nationwide shortage and noted that gels and creams are other options.

Critics question the process

The FDA did not convene an outside advisory committee before the decision, and officials said the evidence behind it could be provided later when reporters asked. Reshma Ramachandran, a health services researcher at Yale School of Medicine, said the blanket removal of warnings “without clear justification can be misleading for patients and underplays real potential harms,” particularly for women with a history of hormone-sensitive cancers.

Estradiol patches are generally considered lower risk than oral hormone pills because the hormone enters the bloodstream without first passing through the liver, though risks rise at higher doses. Women considering hormone therapy should review their personal and family history with a clinician.

In a related notice published Friday in the Federal Register, the FDA also pushed back by six months, to May 4, 2027, the date after which certain unapproved estrogen-androgen combination products could no longer be shipped, saying it needs more time to consider issues raised by interested parties.