HHS revises hormone therapy black box warning. Here's what it means for patients and clinicians
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Menopause providers have been asking and advocating for this change for years.
—Cathleen Brown, DO
Removing the black box warning will help ease people's fears and boost accessibility. This changes that by opening the door for discussion and encourages clinicians to learn more about these medications.
—Katie Rowan, MD
The Food and Drug Administration (FDA) announced that hormone replacement therapy (HRT) drugs will no longer require a black box warning—a strong advisory highlighting potential adverse side effects that has been in effect since the early 2000s.
During a press conference hosted on November 10, 2025, FDA Commissioner Marty Makary, MD, MPH, explained that a study conducted by the Women’s Health Initiative (WHI) in 2002 published misleading findings that triggered a wave of misinformation, leading people to fear that HRT causes breast cancer. []
“Fifty million women since that study 23 years ago have been denied or never offered or talked out of the life-changing, lifesaving benefits of hormone replacement therapy,” Dr. Makary said.
Related: Oncologist debunks myth about local estrogen concerns ahead of FDA's decisionDoctors react to the news
Cathleen Brown, DO, a board-certified OB/GYN and medical director of the telehealth company Winona, says the announcement is great news that has long been needed. “Menopause providers have been asking and advocating for this change for years,” Brown tells MDLinx.
Subsequent analyses of the WHI study have revealed that the risks were misinterpreted and overstated. [] And newer research has linked HRT to several benefits, including menopause symptom relief, improved cardiovascular health, cognitive benefits, and reduced risk of fractures. [][]
“We’ve learned that many of the risks initially attributed to hormone therapy don’t hold up when you look at the full data and consider factors like age and timing of treatment,” Katie Rowan, MD, an internal medicine physician and Menopause Society–certified practitioner, tells MDLinx.
Still, many clinicians dismiss patients who inquire about HRT or suggest alternative treatment options like antidepressants, research shows. []
“Removing the black box warning will help ease people's fears and boost accessibility. This changes that by opening the door for discussion and encourages clinicians to learn more about these medications,” Dr. Rowan adds.
Related: 10 black box warnings every physician should know