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Jul 17, 2025  |  
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Benedict Smith


US could scrap health warnings on HRT

The US could scrap warnings on hormone replacement therapy (HRT) in a major shake-up of the treatment for menopause.

The Food and Drug Administration (FDA) is convening a panel on Thursday afternoon, featuring several proponents of the therapy, to discuss whether federal guidelines overstate the risk to women.

Currently, HRT and other treatments that use oestrogen warn that it could increase the risk of strokes, blood clots, dementia and breast cancer, and should not be used to prevent cardiovascular disease or dementia.

However, Marty Makary, the head of the FDA, has claimed the risks of the treatment – used for hot flushes and other menopausal symptoms – are exaggerated and that its benefits are “overwhelming”.

“For decades, hormone replacement therapy for women… has helped women alleviate the symptoms of menopause, including hot flushes, dryness, mood swings, weight gain and poor sleep quality, to name a few,” Dr Makary said.

When treatment begins 10 years ahead of the menopause, HRT could reduce the risk of cognitive decline and Alzheimer’s and prevent osteoporosis and cardiovascular disease, he added.

No opportunity for public comment

Dr Makary blamed declining use of HRT on a clinical trial in the early 2000s – halted after recording increased risks of breast cancer and strokes – which he said had not been replicated in later studies.

He has previously claimed on a podcast there is “no medication that improves the health outcomes of a population” apart from antibiotics.

The issue is still controversial in the medical community, however.

Critics said the panel includes a number of physicians who agree with Dr Makary’s stance on HRT, and does not have the opportunity for public comment, according to The New York Times.

“This is not like any other public meeting held by the FDA in the past,” said Diana Zuckerman, president of the National Centre for Health Research think tank.

“No one in the audience is being allowed to speak. No one can ask questions,” she continued, saying most participants had a positive view of hormone therapy.

‘Menopause should not be medicalised’

The description of the event on the FDA website reads: “Hormone replacement therapy has long been an important treatment option for women to alleviate symptoms of menopause, among other potential health benefits.

“Over the last two decades, however, HRT has been surrounded by confusing narratives about potential risks.”

Earlier this week, the American Journal of Physicians published an editorial concluding HRT brought limited benefits and significant harms.

“Menopause is a positive life experience for many women and should not be medicalised,” its authors wrote.