FDA Removes Black-Box Warnings From 3 Menopause Patches

The US Food and Drug Administration will remove black-box warnings about cardiovascular disease, breast cancer and dementia from three more menopause patches, officials said Friday.

The agency did not convene an advisory committee and offered few details on the science behind the decision. When journalists asked for the evidence, officials said they could provide it later. The move follows February, when the FDA removed black-box warnings from six menopause treatments.

Reshma Ramachandran, a Yale School of Medicine assistant professor and health services researcher, objected. "I have been concerned by the lack of transparency behind these decisions," she said. She argued that blanket removal without clear justification can mislead patients and underplay real harms, especially for people with histories of hormone-sensitive cancers.

Officials pointed to shortages instead. Dorothy Fink, deputy director of the National Institute of Child Health and Human Development, said the agency is working with manufacturers to strengthen supply, and that estrogen patch manufacturing has doubled over the past year.

Sarah Ibrahim, deputy center director for regulatory programs at the FDA's Center for Drug Evaluation and Research, said demand for estradiol patches rose significantly after the February label change. Patients in many areas struggled to find their usual patches at their usual pharmacy. "We hear you," she said.

Common questions

What warnings is the FDA removing from menopause patches?

The FDA is removing black-box warnings about cardiovascular disease, breast cancer and dementia from three more menopause patches. Officials announced the change Friday. It follows February, when the agency removed black-box warnings from six menopause treatments. The article does not name which three patches are affected.

Did the FDA consult an advisory committee on this?

No, the FDA did not convene an advisory committee before making this decision. Officials offered few details on the science behind it, and when journalists asked for the evidence, they said they could provide it later. The move follows February, when the FDA removed warnings from six other menopause treatments.

Who has objected to the FDA's decision?

Reshma Ramachandran, a Yale School of Medicine assistant professor and health services researcher, objected to the move. She said she is concerned by the lack of transparency behind these decisions. She argued that removing warnings without clear justification can mislead patients and underplay real harms.

FDA again bypasses advisers to remove black-box warnings from menopause treatments

Common questions

What warnings is the FDA removing from menopause patches?

Did the FDA consult an advisory committee on this?

Who has objected to the FDA's decision?

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