FDA ends hormone therapy warning, says safe for menopause care

WASHINGTON — The Food and Drug Administration is reversing a 2003 decision that put a stringent warning on hormone therapy products for menopausal women, saying that the treatments offer heart, brain, and bone health benefits.

Commissioner Marty Makary wrote in a Wall Street Journal op-ed on Monday that the FDA is removing black box warning labels from all-combined estrogen-progestogen, estrogen-only, other estrogen-containing, and progestogen-only products used for hormone therapy.

“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,” he wrote.

The impetus for the black box warning was a 2002 landmark study called the Women’s Health Initiative that suggested that hor