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

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