FDA Pulls Warning Labels From Hormone Replacement Therapies (3)

Nov. 10, 2025, 11:14 PM UTC

Hormone replacement therapies used to treat menopause symptoms no longer need to carry strict warnings about some potential side effects, including cancer and heart disease, the US Food and Drug Administration announced Monday.

Commissioner Marty Makary said the agency is asking drugmakers to remove the strict black box warnings, with the goal of encouraging more women to take them. Labels on the medicines currently list potential side effects including cardiovascular disease, blood clots, breast cancer and dementia.

“Tragically, tens of millions of women have been denied the life-changing and long-term health benefits of hormone replacement therapy,” Makary said. “For too ...

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