FDA removes strictest warnings from hormone therapy after 20 years |
“For more than two decades, bad science and bureaucratic inertia have resulted in women and physicians having an incomplete view of HRT,” Health and Human Services Secretary Robert F. Kennedy Jr. said Monday as the FDA announced it will remove black box warnings from hormone replacement therapy products.
The warnings stem from a 2002 Women’s Health Initiative (WHI) study that found increased risks of heart disease, breast cancer, and blood clots in women taking HRT. Use dropped 45% almost immediately. But that study included older women who started therapy years after menopause, a detail that matters more than anyone realized.
For example, a review article published in May 2022 noted that HRT significantly reduces cardiovascular disease and all-cause mortality when started in women younger than 60 years of age and/or at or near menopause. A more recent review found that the risk of cognitive decline and bone fractures also decreases.
The FDA will keep warnings about endometrial cancer risk for estrogen-alone products but is updating language around cardiovascular, breast cancer, and dementia risks.
For more on the evidence behind this reversal, which women benefit most from HRT, and how to discuss options with your doctor, jump to “FDA removes warning label on HRT for menopause: 5 experts explain.”
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