Many experts feel that with the exception of antibiotics and vaccines, there may be no medication in the modern world that can improve the health outcomes of older women on a population level more than hormone therapy.
Despite this, the role of hormone replacement therapy (HRT) for perimenopausal and menopausal women has been the subject of controversy for years.
A few weeks ago, the US Food and Drug Administration (FDA) announced that it will remove the so-called “black box” warnings from many HRT products used for menopause.
This black box warning is the strongest safety signal the agency places on a drug—meant to highlight serious risks such as cardiovascular disease, stroke, cancer or dementia.
Under the new guidance, references to elevated risk of heart disease, breast cancer, and probable dementia will be removed from most oestrogen—or oestrogen/progestogen-containing HRT products. However, one warning will remain: oestrogen-alone therapies for women with a uterus will still carry a caution about the risk of endometrial cancer.
But why were these black box warnings there in the first place, and what prompted their removal?
The story dates back to the early 2000s, when a landmark study, the Women’s Health Initiative (WHI), reported that women using certain types of HRT had higher rates of breast cancer, heart disease, stroke, and blood clots—prompting the FDA to apply the black box warning to essentially all menopausal HRT.
However, over time, researchers have shown that the WHI study had important limitations: the average age of participants was about 63, often many years after menopause onset; and the therapies used were older, synthetic formulations, administered orally — not always representative of modern HRT regimens.
Over the intervening years, additional research has refined our understanding. More recent analyses suggest that when HRT is initiated closer to the onset of menopause (for example within ten years) or before age 60, the risks are lower, and in many cases the benefits outweigh risks.
This evolving evidence—plus clinical experience and improved hormone formulations (including transdermal patches and gels)—prompted regulators to reassess the rigid “one-size-fits-all” warning approach.
After all, in the past, the previous black box warnings scared off many women and even doctors so much that HRT usage dramatically dropped in the early 2000s. The widespread panic and abrupt withdrawal of HRT for millions of women, led to unnecessary suffering from menopausal symptoms and potential long-term health deterioration.
It is thought that the fear associated with HRT use prevented approximately 50 million women worldwide from taking advantage of the short- and long-term health benefits of this therapy. A fear now largely unfounded due to the misinterpretation and overgeneralisation of the WHI study’s results
With the recent label change, hopefully the stigma and fear around HRT may ease, potentially making it a more accessible and acceptable option for women suffering from menopausal symptoms such as hot flashes, night sweats, vaginal dryness, mood changes, sleep disturbances, or bone loss.
It also reflects a broader shift in medicine: from a one-size-fits-all guidelines based on limited data, to a more individualised, nuanced understanding grounded in decades of evolving research. For many women who have suffered silently through menopause symptoms, which can be persistent and quality-of-life disrupting—this change opens the door to safer, more effective treatment.
