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

30 October 2026 at 19:15

Some experts express concern about ‘lack of transparency’ as agency removes warnings on three estrogen patches

Three more patches for treating menopause will no longer carry black-box warnings about cardiovascular disease, breast cancer and dementia, officials at the US Food and Drug Administration (FDA) said on Friday.

The FDA did not convene an advisory committee and offered few details on the scientific basis for the decision in the press briefing. The news follows the removal of black-box warnings from six menopause treatments in February, as patients across the US struggle with shortages of the patches.