'Black box' safety warning to be removed from hormone therapy for menopause

Source: CNN

In a pivotal move, the US Food and Drug Administration on Monday said it is taking steps to remove the lengthy “black box” warning on many hormone treatments for women with menopause symptoms — a shift expected to give women more options for treatment and generate a flood of new prescriptions.

Hormone therapy has long been on the market, but prescriptions plummeted after 2003, when the warning described increased risks of cardiovascular disease, stroke, breast cancer and dementia.

Prescribing requires nuance, FDA officials said Monday. Hormones should be used in women who are younger than age 60 or within 10 years of menopause. Some women still face some risks from hormones, including women at increased risk of blood clots or who have previously had breast cancer.

“Today, the U.S. Food and Drug Administration is requesting that drug manufacturers remove black box warnings from these products,” FDA Commissioner Dr. Marty Makary said in an opinion in The Wall Street Journal. “These are the strongest drug warning the agency can require, and they have inappropriately scared women off from this life-changing, and sometimes life-saving, treatment.”

Read more: https://www.cnn.com/2025/11/10/health/hormone-therapy-menopause-fda-warning-wellness