FDA to remove black box warning from hormone replacement therapy drugs

Blister packs of hormone replacement therapy medication. (Getty photos)

WASHINGTON — The U.S. Food and Drug Administration announced Monday it plans to remove warnings from hormone replacement therapy drugs that can be used to address symptoms of menopause, saying the statements are no longer needed.

The black box warning, the strongest caution possible from the FDA, was added in the early 2000s after a study from the Women’s Health Initiative showed an uptick in rates of blood clots, breast cancer, heart attacks and strokes for women who used certain types of hormone replacement therapy.

FDA Commissioner Marty Makary said during a press conference the change for estrogen-related products “is based on a robust review of the latest scientific evidence.”

Makary rebuked the medical establ