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Food and Drug Administration may soon revise hormone replacement therapy warnings

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18th July, 2025 06:22 IST

Washington DC - US Food and Drug Administration Commissioner Marty Makary signaled Thursday that he is open to revising strict warning labels on Hormone Replacement Therapy, following testimony from experts who said the treatment's risks have long been exaggerated.

image Food and Drug Administration Commissioner Marty Makary (pictured) speaks as he joins US President Donald Trump in the Oval Office at the White House on May 5, 2025 in Washington, DC. © Anna Moneymaker / GETTY IMAGES NORTH AMERICA / Getty Images via AFP

HRT is taken to replace estrogen the body stops producing after menopause – when periods end permanently – and helps relieve symptoms such as hot flashes, vaginal discomfort, and pain during sex.

But its use has plummeted in recent years amid concerns including a possible link to invasive breast cancer.

Food and Drug Administration (FDA) chief Marty Makary, who convened Thursday's meeting of outside experts, told AFP: "We have to revisit these topics."

He argued that the framework that led to so-called "black box warnings" – the strongest warning the FDA can require for prescription drugs – "came from a different era."

"Not only is there no clinical trial showing an increase in breast cancer mortality, but there are also other tremendous long-term health benefits," Makary added.

What did the HRT panel experts have to say? image The University of Arizona researcher linked menopause to a drop in the brain's ability to metabolize glucose and a rise in protein plaque deposits (stock image.) © Unsplash/Robina Weermeijer

The 12 experts convened by the agency said HRT's benefits go beyond easing menopausal symptoms. They cited evidence for reduced fracture risk, improved cardiovascular and cognitive health, and fewer urinary tract infections.

"Estrogen is the only well-established intervention to reduce the frequency of osteoporotic fracture in postmenopausal women, to the tune of 30 to 50%," said Vonda Wright, an orthopedic surgeon at the University of Central Florida.

Roberta Diaz Brinton, director of the Center for Innovation in Brain Science, said her research suggests the reason two-thirds of people globally with Alzheimer's are women is not because they live slightly longer than men, but because the disease begins during the menopausal transition.

"Depending upon when hormone therapy is introduced... there's a significant reduction in risk of developing Alzheimer's disease," she said.

The University of Arizona researcher linked menopause to a drop in the brain's ability to metabolize glucose and a rise in protein plaque deposits.

Panelists blamed the collapse in HRT use on the Women's Health Initiative (WHI), a landmark clinical trial halted in 2002 after flagging a possible increased breast cancer risk – findings they say were misinterpreted.

"Prescriptions for hormone replacement therapy plummeted in the United States, women flushed their pills down the toilet," Makary said in his opening remarks, mentioning his own mother's experience of multiple bone fractures in old age.

Critics of the WHI argue it included participants well past menopause – when risks are higher and benefits lower – and used outdated formulations no longer common today.

Still, the issue remains divisive within the medical community. HRT can be administered through various means including orally, through skin patches, or vaginally; and is given either as estrogen alone or with progesterone.

The FDA's own warning label for it cites risks including endometrial cancer, breast cancer, and life-threatening blood clots.

Panelists criticized as "one-sided" and biased

Adriane Fugh-Berman, who directs a project that promotes rational prescribing at Georgetown University, attended as an observer and criticized the lack of dissenting voices.

"This was a very one-sided panel of people who are all proponents of hormone therapy and who seem to have a very poor understanding of the evidence," she told AFP.

"While hormones can be a useful treatment for severe menopausal symptoms, they should not be used for chronic disease prevention," she added, noting that no randomized clinical trial – the gold standard of evidence – has found HRT beneficial for cognition or dementia prevention.

She also said that after the WHI findings were released, hormone use fell globally – and breast cancer rates dropped across registries tracking them.

Several of the panelists had ties to companies offering menopause treatments or are affiliated with the advocacy group "Let's Talk Menopause," which receives pharmaceutical funding and campaigns to revise FDA warning labels.

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