The US Food and Drug Administration (FDA) is working with manufacturers to remove black box warnings across hormone replacement therapy (HRT) products used to treat symptoms of menopause in an effort to drive their use.
According to the agency, the use of HRT drugs plummeted after introduction of black box warnings in 2003.
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At a press conference, US Department of Health and Human Services (HHS) secretary Robert F Kennedy (RFK) Jr said: “For more than two decades, bad science and bureaucratic inertia have resulted in women and physicians having an incomplete view of HRT.”
The news followed an FDA expert panel convened in July to review data from the Women’s Health Initiative (WHI) studies that led to the boxed warning requirements on all oestrogen and oestrogen/progestin treatment for menopause. The agency recently suggested a shift away from a reliance on advisory committees, eliciting concerns about the transparency and scientific basis of decisions driving drug approvals, before backtracking on any plans to do away with such committees.
The FDA stated that a key WHI finding that indicated an increased risk of breast cancer in women treated with hormone therapy was found to be statistically non-significant. It was also highlighted that the average age of women in the study (63 years) was more than ten years higher than the typical age for the onset of menopause. Additionally, the 10 November FDA release stated that the hormone formulation included in the study is no longer used commonly.
As a result, product labelling will be updated to remove references to the increased risk of “cardiovascular disease, breast cancer and probably dementia”, as per the release.
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By GlobalDataIn a press conference announcing the change, FDA commissioner Marty Makary described how women undergoing menopause suffer from night sweats, weight gain, along with other symptoms like hot flashes and mood swings, and called out their effect on their personal lives.
There are numerous potential health benefits of HRT, including a 50% reduction in risk for heart attacks, a 64% reduction in cognitive decline, and 35% lower risk of Alzheimer’s disease, according to the HHS. The agency also stated that a review of literature indicated a decreased rather than increased cancer mortality risk associated with HRT.
Though findings from the WHI studies support use of HRT for treating symptoms of menopause such as hot flushes in women without contraindications, the evidence does not support use in prevention of cardiovascular disease, dementia or other chronic illnesses. The landmark WHI programme enrolled 161,808 postmenopausal US women from 1993–1998 and followed participants for as long as 20 years across several clinical trials, as per a May 2024 Journal of the American Medical Association (JAMA) publication.
