HRT No Longer Has a Black Box Warning — Here’s What That Means

After two decades, the U.S. Food and Drug Administration (FDA) has lifted its black box safety warnings1 from all hormone replacement therapy (HRT) products prescribed for menopause and perimenopause. 

The decision marks a historic shift in how women’s health is treated, signaling an end to decades of fear-based messaging that discouraged millions from accessing safe, effective relief for menopause symptoms.

Until now, all estrogen-containing therapies (creams, patches, pills, and more) carried a “black box” warning, the FDA’s most severe caution label. The warning, introduced after the 2002 Women’s Health Initiative (WHI) study, suggested that hormone therapy could increase the risk of breast cancer, heart attacks, strokes, and dementia, which was deeply flawed.

Those warnings dramatically reshaped women’s health care. Overnight, millions stopped taking hormone therapy, and many clinicians stopped prescribing it altogether. Over the last 23 years, an estimated 50 million women have been denied, or never even offered, HRT due to those fears.

But as new research emerged, it became clear that the risks cited in 2002 were overstated and misunderstood. The WHI data primarily reflected outcomes in women who were, on average, 63 years old (well past the age when hormone therapy is typically initiated) taking conjugated equine estrogens (CEE) and medroxyprogesterone acetate (MPA)—two forms of hormone therapy no longer in use today.

In reevaluating the data, the FDA reviewed large-scale studies demonstrating that hormone therapy, when appropriately prescribed (at an appropriate age and dose), can improve both short- and long-term health outcomes. Evidence cited showed that estrogen therapy was linked with lower risks of Alzheimer’s disease4, heart attack5, and hip fracture6.

Only one black box warning will remain, highlighting the risk of endometrial cancer in women who take estrogen without progesterone balance. For women with a uterus, combining estrogen with adequate progesterone remains standard to mitigate this risk.

This decision represents more than a regulatory update; it’s a cultural correction. For years, women have been told to “tough it out” through menopause, even though over 80% experience symptoms that can be severe or debilitating. These include hot flashes, mood swings, weight gain, and disrupted sleep8—symptoms that last an average of eight years and can affect every aspect of life.

At mindbodygreen, we view this change as both overdue and transformative. The removal of the black box warning aligns with decades of data showing that hormone therapy, when started appropriately, is both safe and beneficial for many women. Beyond alleviating symptoms like hot flashes and sleep disturbances, HRT can support cardiovascular, bone, and cognitive health as women age.

Still, hormone therapy isn’t one-size-fits-all. The type of hormones used (bioidentical vs. synthetic), the delivery method (pill, patch, pellet, or cream), and the timing of initiation all matter. Working with a clinician who specializes in menopause care can help tailor treatment to your unique needs, goals, and medical history.

And while HRT can be a powerful tool for longevity, its benefits are amplified by the foundation of a healthy lifestyle—regular exercise, strength training, nutrient-dense eating, restorative sleep, and stress management all play key roles.

Without the shadow of a black box warning, more doctors may feel comfortable prescribing HRT, and more women can make informed decisions based on evidence, not fear.