Beyond the black box: What women deserve to know about menopause hormone therapy

Last week, the FDA announced it has initiated the process of removing the black box warning from menopause hormone therapy (MHT; often called hormone replacement therapy or HRT) products. The announcement was rife with falsehoods and failed to follow the appropriate processes, but that, sadly, is no longer surprising.

Beneath the surface lies something important: menopause, a universal biological transition, remains deeply misunderstood in medicine, and millions of women have suffered because of it. There are signs that the tide may finally be turning toward more evidence-based, compassionate care, but we still have a long way to go.

To unpack how we got here and what women still deserve to know, I called in Nikki Sapiro Vinckier—OBGYN PA-C and reproductive health educator—to walk through the evidence, the uncertainties, and how individual history shapes each woman’s risk–benefit picture.

How we got here: What we used to believe and how it changed

The history of hormone therapy is nearly 85 years of swinging between enthusiasm, fear, and recalibration.

After decades of being used primarily for symptomatic relief, hormone therapy in the 1980s began to be prescribed to prevent chronic disease. This shift was driven by observational studies suggesting lower rates of heart disease and even hinting that women with existing heart disease had fewer second heart attacks while on hormones.

Why did this seem plausible? Because decreases in estrogen have wide-reaching effects across nearly every major organ system. As estrogen falls blood vessels stiffen, cholesterol worsens, bones weaken, metabolism shifts toward greater abdominal fat and insulin resistance, and brain and urogenital tissues lose important support.

These biologically plausible pathways helped fuel enthusiasm, but the studies weren’t designed to measure cause and effect.

This ultimately led to the initiation of a study by the Women’s Health Initiative (WHI)—the largest randomized controlled trial involving more than 27,000 post-menopausal women, designed to test whether MHT could prevent chronic diseases such as heart disease. The study found no cardiovascular benefit and an increase in strokes and breast cancer (24% increase or about 8 extra breast cancer cases per 10,000 women per year). The trial was stopped early in mid-2002 because of emerging risk signals.

Almost overnight, MHT was seen not as preventive medicine but as potentially dangerous. Suddenly, the treatment was no longer routinely recommended, and FDA put a black box warning on estrogen-containing therapies—the strictest warning label, meant to draw attention to drugs with potentially ...