FDA moves to lift ‘black box’ warnings from hormone therapies for menopause symptoms

The U.S. Food and Drug Administration (FDA) announced it is initiating the removal of "black box" informing labels from hormone replacement therapy (HRT) products utilized to easiness menopause symptoms, a determination Commissioner Dr. Marty Makary said is backed by decades of probe connected the therapy’s benefits and objective trials that bash not enactment earlier fears linking it to higher bosom crab mortality.

Health and Human Services Secretary (HHS) Robert F. Kennedy Jr. said astatine a property league alongside Makary connected Monday that the alleged "black box" labels, the strongest warnings for medicine drugs the bureau tin require, were designed to "frighten women and to soundlessness doctors."

"It warned of diseases and dangers that the information simply did not support. Bureaucrats astatine the FDA reacted retired of fear, not golden modular science. And alternatively of correcting the record, the aesculapian constitution doubled down successful groupthink," said Kennedy. "The consequences person been devastating."

FDA Commissioner Dr. Marty Makary and HHS Secretary Robert F. Kennedy Jr. denote informing letters to companies selling products with 7-hydroxymitragynine during a quality league astatine HHS office successful Washington, DC, connected July 29, 2025. (SAUL LOEB/AFP via Getty Images)

Makary added that a 2002 survey known arsenic the Women’s Health Initiative — which fueled concerns astir hormone therapy and bosom crab — was "misrepresented and created a fearfulness machine."

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He wrote successful a Monday op-ed successful The Wall Street Journal hours earlier the authoritative announcement that HRT, which "consists of estrogen and progesterone (or estrogen unsocial for women who person had a hysterectomy)," is simply a "breakthrough for galore women."

"It alleviates the short-term symptoms of menopause, including blistery flashes, nighttime sweats, temper swings and value gain, and erstwhile started wrong 10 years of menopause it has underappreciated semipermanent wellness benefits that adjacent doctors whitethorn not beryllium acquainted with."

Hormone replacement therapy, utilized to negociate menopause symptoms by supplementing hormones the assemblage nary longer produces sufficiently.

The "black box" warnings, which were archetypal added successful 2003, were based connected misinterpreted information and discouraged millions of women from utilizing HRT, according to the FDA commissioner.

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Makary highlighted a 1991 UC San Diego reappraisal that recovered HRT whitethorn trim fatal coronary events by astir 50% and a 1996 survey from the University of Southern California that recovered women utilizing estrogen replacement therapy had a 35% little hazard of Alzheimer’s illness compared with nonusers.

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Kelly Casperson, a board-certified urologist, said astatine the HHS lawsuit that the FDA’s measurement to region the "black box" informing statement would assistance "correct decades of misleading guidance."

"The FDA's determination to region the container informing is not conscionable regulatory," she said. "It's revolutionary."