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FDA commissioner stirs debate over hormone therapy for menopause

14 36
22.07.2025

A Food and Drug Administration expert panel has reignited a debate over whether hormone therapy should be used to treat menopause.

The 12-person panel encouraged the use of the treatment late last week and called for the removal of the Food and Drug Administration’s “black box” warning label on hormone treatments.

“I am begging the FDA, and all of us are begging, please remove the black box label,” said JoAnn Pinkerton, a panelist and professor of obstetrics and gynecology and division direct of midlife health at the University of Virginia Health System. She specifically referred to low-dose vaginal estrogen therapies. “Please stop harming women.”

Women’s health experts have long had mixed thoughts on menopause hormone therapy, with some arguing that the side effects outlined in the Women’s Health Initiative were overblown while others still believe the treatment poses serious long-term health risks.

“Menopausal hormone therapy is effective for vasomotor symptoms and vaginal dryness, but those are the only proven symptomatic benefits,” Adriane Fugh-Berman, a professor of pharmacology at Georgetown University Medical Center, and Barbara Mintzes, a professor of pharmaceutical policy at the University of Sydney wrote in

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