FDA Removes Black-Box Warnings from Additional Menopause Patches

The U.S. Food and Drug Administration (FDA) has announced the removal of black-box warnings regarding breast cancer, dementia, and cardiovascular disease from three menopause treatment patches. This follows a similar action taken in February involving six other treatments.

Agency officials stated that the previous warnings overstated risks for many healthy women under 60 who are within a decade of menopause onset. They noted that estradiol patches are generally considered lower risk than synthetic oral medications.

The FDA did not convene an advisory committee to review the decision, a move that has drawn criticism from some health researchers. Concerns have been raised about the lack of transparency and the potential for patients to be misled regarding the risks of hormone therapy.

In response to reports of patient frustration and supply shortages, the FDA is collaborating with manufacturers to increase production. The agency is also considering making vaginal estrogen products available over the counter.