The US Food and Drug Administration (FDA) may reconsider the strict warning labels currently attached to Hormone Replacement Therapy (HRT), with Commissioner Dr. Marty Makary indicating that it may be time to re-evaluate the treatment’s risks in light of evolving scientific evidence.
Speaking after a high-level expert panel meeting, Makary told AFP, “We have to revisit these topics.” He suggested the framework that led to the “black box” warning, the FDA’s most severe label, stems from an outdated understanding of HRT. “Not only is there no clinical trial showing an increase in breast cancer mortality, but there are also other tremendous long-term health benefits,” he said.
HRT, commonly used to relieve menopausal symptoms like hot flashes, vaginal dryness, and pain during sex, has seen a steep decline in use over the past two decades, largely due to concerns raised by the 2002 Women’s Health Initiative (WHI) study, which linked the therapy to increased breast cancer risk. However, many experts now argue those results were misinterpreted and that more recent research suggests a more nuanced view of HRT’s benefits and risks.
Also Read | UK approves first non-hormonal daily pill to ease menopausal hot flushes
The FDA-convened panel of 12 experts cited a range of benefits beyond menopausal symptom relief. They pointed to evidence that HRT can reduce osteoporotic fractures by 30–50%, lower the risk of urinary tract infections, and potentially support cardiovascular and cognitive health.
Dr. Vonda Wright, an orthopaedic surgeon at the University of Central Florida, stated that oestrogen remains “the only well-established intervention” to reduce fractures in postmenopausal women.
Meanwhile, Dr. Roberta Diaz Brinton, a neuroscientist from the University of Arizona, presented findings linking menopause-related hormonal changes to early-stage Alzheimer’s disease. Her research suggests that oestrogen therapy, introduced during the menopausal transition, may significantly reduce the risk of developing the disease.
Makary also shared a personal anecdote, recalling how his mother, after discontinuing HRT due to fear from the WHI findings, later suffered multiple bone fractures.
Despite growing calls for change, the issue remains highly contentious within the medical community. HRT can be administered orally, through skin patches, or vaginally and is prescribed either as oestrogen alone or in combination with progesterone. The FDA’s current warning label cites risks including endometrial cancer, breast cancer, and life-threatening blood clots.
Dr. Adriane Fugh-Berman, of Georgetown University, who attended the meeting as an observer, criticised the panel for lacking diverse viewpoints. “This was a very one-sided panel of people who are all proponents of hormone therapy,” she told AFP, warning that no randomised clinical trial has definitively shown HRT can prevent dementia or cognitive decline.
