A change decades in the making but disputed by critics
The agency says newer evidence shows hormone therapy risks depend on age, timing and dose
Somecall it a major step toward modernizing womens health care
Some doctors still urge caution for older women and those with existing health risks
The U.S. Food and Drug Administration has removed the black box safety warning from most hormone therapies used to treat menopause symptoms, ending a 20-year era of caution that began after the landmark Womens Health Initiative (WHI) study. FDA said the move reflects growing scientific consensus that the dangers once associated with hormone therapybreast cancer, heart attack, stroke and blood clotsare not uniform and depend on a womans age, health history and the timing of treatment.
But not everyone agrees.
HHS and the FDA have claimed that the removal of the boxed warning for hormone replacement therapy will restore gold-standard science to womens health. In fact, the opposite is true. These treatments have well documented cardiovascular, cognitive and cancer safety risks," saidNina Zeldes, PhD, a health researcher at Public Citizens Health Research Group.
The black box warning, the most severe safety label a drug can carry, was added in 2003 after the WHI trials suggested higher risks for older postmenopausal women taking certain estrogen-progestin combinations. But the FDA said researchers have since clarified that those findings applied largely to women who started therapy long after menopause and were using higher doses of oral formulations no longer common today.
"Overblown press conference announcements and unsubstantiated labeling updates do not protect womens health. The FDA should advance womens health by making decisions based on high-quality data from long-term randomized controlled trials and the formal advisory committee process," Zeldes said.
Quick checklist for patients
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Consult a healthcare provider to discuss whether hormone therapy is appropriatefor you, considering age, time since menopause, personal risk factors (e.g., breast cancer, cardiovascular disease).
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Understand the form/delivery of hormone therapy (oral, patch, gel, vaginal) risks and benefits differ by route and dose.
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Ask about the timing: starting closer to menopause onset appears safer than starting many years later.
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Review any personal/family history of cancer, clotting disorders, heart disease these affect appropriateness of HT.
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Ensure regular monitoring/screening (e.g., mammography, cardiovascular risk assessment) as recommended.
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Dont assume therapy is one-size fits all individualized decision-making is key.
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If youve been avoiding therapy due to fear of warnings, ask if updated evidence/recommendations apply to your case.
Updated science and new context
Recent studies show that hormone therapy started within about 10 years of menopause, particularly for women younger than 60, carries far fewer risks and offers clear benefits for symptoms such as hot flashes, night sweats, sleep disruption, and vaginal dryness, according to the FDA. Localized, low-dose estrogenlike creams or ringshas minimal systemic absorption and is now considered safe for most women, yet the old warning covered those products too.
By lifting the black box, the FDA acknowledged that a single blanket warning no longer fits the evidence. This restores nuance and allows doctors and patients to have honest, individualized conversations, said Dr. Stephanie Faubion, medical director of The Menopause Society, which had long urged the change.
The Menopause Society is a non-profit organization whose revenues come fromfees, exhibit/booth fees at conferences, royalties from its journal, and sales of educational materials.It has a Corporate Liaison Council (CLC) programin which companies with a business interest in menopause and mid-life womens health can join by paying annual dues (listed at US $8,000 for 2025). In return, the companies receive benefits such as complimentary membership, complimentary meeting registration, preferred exhibit space, acknowledgement at the annual meeting, website recognition, and so forth.
The list of 2025 CLC member companies (on the website) includes:
- Amgen
- Astellas
- Bayer
- Bonafide Health
- Kenvue
- Novo Nordisk
The organization recentlyannounced a major grant of $5 million from anonymous donorto support the NextGen Now initiative.The program, which is prominently funded by large gifts, is aimed at a large scale training goal (25,000 professionals) and includes digital and video components.
"Well-documented safety risks"
Public Citizen charged that HHS and the FDA have claimed that the removal of the boxed warning for hormone replacement therapy will "restore gold-standard science to womens health" when "in fact, the opposite is true."
Public Citizen said the HRT treatments "have well documented cardiovascular, cognitive and cancer safety risks. Overblown press conference announcements and unsubstantiated labeling updates do not protect womens health." It said the FDA should advance womens health by making decisions based on high-quality data from long-term randomized controlled trials and the formal advisory committee process.
In todays announcement the FDA also seemed to blatantly promote the off-label use of hormone replacement therapy for some conditions for which it is not approved, such as preventing cardiovascular disease and cognitive decline. Unsubstantiated claims by senior FDA officials about the effectiveness of hormone replacement therapy for unapproved indications undermines public trust in the agencys decision-making.
The U.S. Preventive Services Task Force has consistently recommended against hormone replacement therapy for the prevention of chronic conditions in post-menopausal women. Instead of making unsubstantiated claims about improving womens health, the FDA should encourage or fund research that establishes the benefits and risks of short-term and long-term use of hormone replacement therapy, it concluded.
Posted: 2025-11-12 18:04:31
