The Food and Drug Administration (FDA) announced Monday that it will remove black box warnings from hormone replacement therapies used to treat menopause symptoms, citing new scientific evidence that challenges earlier safety concerns.
The black box warnings — the FDA’s most serious safety alert — warned of increased risks of breast cancer, heart attack, and stroke. The decision applies to estrogen- and progesterone-based products prescribed to relieve symptoms such as hot flashes, mood swings, sleep disturbances, vaginal dryness, and urinary tract infections.
FDA Commissioner Marty Makary said during a news conference that the change was based on a comprehensive review of current data. “We are going to stop the fear machine steering women away from this life-changing, even lifesaving, treatment,” Makary said.
In an editorial published in the Journal of the American Medical Association (JAMA), Makary and other FDA officials said the black box warnings were based on outdated studies that have since been challenged by newer research. The agency noted that hormone replacement therapies can play an important role in improving women’s health and quality of life during and after menopause.
Warnings based on older study
The original warnings stemmed from a 2002 clinical trial that was halted after finding higher risks of breast cancer and cardiovascular issues among women receiving hormone therapy. However, that study focused on an older formulation of progesterone and included mainly women in their 60s and 70s — an age group not representative of most hormone therapy users, who typically begin treatment in their 40s or 50s.
Following the trial, prescriptions for hormone replacement therapies dropped sharply. In recent years, newer studies have shown that current formulations do not carry the same level of risk when used under proper medical supervision.
“The warnings have discouraged many women from starting treatment,” said Dr. MargEva Cole, an obstetrician-gynecologist at Duke University School of Medicine. “They leave the office excited to feel better but then read the label and get scared.”
Label changes and new recommendations
The FDA said information about potential risks will remain in package inserts, but the black box section will be removed. The agency will also add a recommendation for systemic hormone therapies, such as pills and patches, suggesting they be started in women younger than 60 or within 10 years of menopause onset, when symptoms are most severe.
Dr. Steven Fleischman, president of the American College of Obstetricians and Gynecologists, supported the FDA’s decision for low-dose vaginal estrogen products, which treat localized symptoms like dryness and infections. However, he cautioned that systemic estrogen therapies still require careful consideration. “Their use should be based on an individualized conversation between patients and their clinicians,” Fleischman said.
Oncologist Dr. Tiffany Troso-Sandoval added that patients with a history of breast cancer should consult specialists before starting systemic hormone therapy. “Despite the removal of the black box warning, these cases still require a nuanced expert discussion,” she said.
Broader impact and future outlook
The FDA also announced the approval of two new menopause treatments — one a generic mix of estrogen hormones and the other a nonhormonal therapy for moderate to severe hot flashes.
The move follows a July expert panel where Makary highlighted research suggesting hormone replacement therapy could help reduce cognitive decline and possibly lower Alzheimer’s risk. However, experts, including Dr. Samantha Dunham of NYU Langone Health, said long-term studies are still needed to confirm those benefits.
For many women, the FDA’s decision could ease access to treatments that improve their quality of life. Beaux Abington, 51, of Florida, said she struggled to find a doctor willing to prescribe hormone therapy during perimenopause. “I was not in a good place. I couldn’t get out of bed,” she said. After beginning treatment, she reported a dramatic improvement in her mood and energy.
The FDA’s updated labeling policy is expected to take effect in the coming months, signaling a shift toward modernized, evidence-based regulation of menopause care in the United States.
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