For more than 20 years, hormone therapy for menopause has carried a warning label from the Food and Drug Administration describing the medication’s risk of serious harms – namely, cancer, cardiovascular disease and possibly dementia.

On Nov. 10, 2025, the FDA announced that drugmakers should remove these “black box” safety warnings.

The Conversation U.S. asked Genevieve Hofmann, a women’s health nurse practitioner at the University of Colorado Anschutz Medical Campus, to explain how the decision will affect health care for people going through menopause or postmenopause.

When people think of hormone therapy for menopause, they generally think of systemic estrogen and progestogens – for example, pills or patches that deliver hormones throughout the body.

Health care providers prescribed hormone therapy to manage symptoms of menopause such as hot flashes, night sweats and brain fog much more widely in the 1980s and 1990s than they do today. That’s because in the early 2000s, researchers analyzed data from a study called the Women’s Health Initiative and reported that hormone therapy increased the risk of breast cancer, heart disease, blood clots and stroke, as well as cognitive decline after menopause.

After this research was first published in 2002, the use of hormone therapy fell by 46% within six months – both because clinicians were reluctant to prescribe it and patients were fearful of taking it. In 2003, the FDA added black box warnings – the most serious warnings, indicating a risk of serious harm or death – to all estrogen-containing hormone products for menopause.

But researchers soon pointed out methodological flaws in the analysis. And over the past two decades, careful........

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