In a major shift that could affect millions of women, the U.S. Food and Drug Administration (FDA) has decided to remove the long-standing “black box” warnings from many hormone replacement therapy (HRT) medications.
These warnings—bold, highly visible labels printed on drug packaging—have for more than 20 years cautioned women about serious risks linked to hormone therapy.
Their removal signals a significant change in how experts now understand the safety of HRT.
Hormone replacement therapy is used to treat uncomfortable menopause symptoms such as hot flashes, night sweats, mood changes, and sleep problems. It is also prescribed to help prevent bone loss and fractures.
HRT usually contains estrogen, progestogen, or a combination of both. For many women, these therapies greatly improve quality of life. But since 2002, they have carried the strictest FDA warning possible.
The original black box warning was based on a large clinical trial more than two decades ago. That 2002 study suggested that women taking a particular type of HRT had an increased risk of breast cancer, heart attack, and stroke.
Those results caused widespread fear, leading many women to avoid hormone therapy altogether. Doctors say the warnings created confusion and prevented women from receiving treatment that could have helped them.
However, researchers have long argued that the 2002 study was misleading. It included mostly women in their 60s and 70s—well past the beginning of menopause—and used a hormone formulation that is not commonly prescribed today.
Most women start hormone therapy in their late 40s or 50s, when treatment may be safer and more effective. Because of this mismatch, experts say the results unfairly shaped public perception of HRT for decades.
Dr. MargEva Cole, an obstetrician-gynecologist at Duke University, said the black box warning had a strong emotional effect. Many women left their doctor’s office ready to begin treatment, only to read the label at home and decide not to take the medicine out of fear.
She said this has stopped countless women from receiving help that could have eased their symptoms and improved daily life.
More recent studies have used modern hormone formulations and included women who match the typical age range for HRT. These studies have not found the same increased risks reported in 2002.
As a result, FDA officials, including Commissioner Dr. Marty Makary, concluded that the black box warnings were outdated and no longer supported by current evidence.
Although the warnings are being removed, the FDA is still advising women to follow certain guidelines. The agency now recommends that women who choose systemic HRT—pills or patches that affect the whole body—begin treatment before age 60 or within 10 years of starting menopause.
Starting early may offer protective benefits, including a lower risk of cognitive decline and heart disease. Still, the FDA emphasizes that hormone therapy is not right for everyone. The decision must be made between a woman and her doctor, based on her symptoms, health history, and personal preferences.
Dr. Samantha Dunham, director of the Center for Midlife Health and Menopause at NYU Langone Health, notes that non-hormonal options also exist. Cognitive behavioral therapy, lifestyle changes, and certain medications may help women who prefer to avoid hormones or cannot use them safely.
Even though the dramatic black box warnings will no longer appear, detailed risk information will still be included in the package inserts. These will explain possible side effects and help guide informed decisions.
Reviewing these developments, the FDA’s action reflects a more nuanced understanding of HRT. The original warnings created two decades of fear, but modern science shows a clearer picture: for many women, especially those under 60 or near the start of menopause, hormone therapy can be safe and highly effective.
Removing outdated warnings may help millions access treatment without unnecessary fear. However, HRT is still not a universal solution, and careful discussions between patients and clinicians remain essential.
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