New publication highlights historic FDA decision and calls for a shift from fear-based to evidence-based menopause care
TOWARD Health is proud to announce that Dr. Laura Buchanan has published a new peer-reviewed article in Menopause, examining one of the most consequential regulatory shifts in women’s health in decades: the removal of the FDA boxed warning from menopausal hormone therapy (MHT).
The paper explores how this long-standing warning, originally implemented in the early 2000s, shaped clinical practice, prescribing behavior, and patient access to care for over 20 years, and why its removal marks a critical turning point in menopause management.
A Historic Shift in Women’s Health
In November 2025, the FDA removed the boxed warning from menopausal hormone therapy, a decision that reflects decades of evolving evidence and improved understanding of hormone therapy risks and benefits.
Dr. Buchanan’s publication highlights that the original warning was based on data from a single trial evaluating one specific formulation, yet it was broadly applied across all hormone therapies regardless of dose, formulation, or route of administration.
Over time, this led to widespread avoidance of hormone therapy despite mounting evidence demonstrating that risks and benefits vary significantly depending on factors such as age, timing of initiation, and formulation.
The Consequences of Outdated Risk Messaging
The impact of the boxed warning extended far beyond labeling.
According to the publication, hormone therapy use declined dramatically from nearly 40% of women to under 5%, despite the fact that up to 80% of women experience menopausal symptoms.
This shift in practice patterns was not without consequence. Reduced use of hormone therapy has been associated with:
- Increased cardiovascular risk
- Higher rates of osteoporosis and fractures
- Worsening quality of life
- Potentially avoidable morbidity and mortality
The paper underscores that regulatory messaging, when not updated in step with evolving science, can shape care delivery for decades.
What the Evidence Now Shows
Dr. Buchanan’s work synthesizes decades of follow-up data and modern research, demonstrating that menopausal hormone therapy is not a one-size-fits-all risk.
Key insights include:
- Risks and benefits vary significantly by age and timing of initiation
- Women under 60 or within 10 years of menopause often have a more favorable risk profile but still not contraindicated in older ages
- Route and formulation matter, with transdermal and body-identical therapies showing different risk patterns than earlier formulations
- Long-term data show no increase in all-cause mortality associated with hormone therapy
This nuanced understanding challenges outdated assumptions and supports a more individualized, patient-centered approach to care.
A Call for Modern, Individualized Care
The removal of the boxed warning is more than a regulatory update: it is an opportunity to redefine menopause care.
The publication calls for:
- Improved clinician education and training in menopause management
- Updated clinical guidelines that reflect current evidence
- Greater emphasis on individualized risk-benefit discussions
- Integration of menopause care into primary care practice
Notably, the paper highlights that only a small percentage of clinicians feel adequately trained to manage menopause, underscoring a major gap in care delivery.
From Policy Change to Practice Change
At TOWARD Health, this shift reflects what we have long believed: that women deserve care grounded in physiology, evidence, and individualized decision-making rather than outdated fear.
Dr. Buchanan’s work reinforces a broader movement toward:
- Root-cause, metabolic-driven care
- Personalized treatment strategies
- Integration of lifestyle and medical interventions
- Empowering both patients and providers with accurate, current information
Looking Ahead
The removal of the FDA boxed warning marks a true inflection point, but the work is not done. As Dr. Buchanan outlines, aligning clinical practice with modern evidence will require continued education, updated guidelines, and a commitment to rethinking how menopause is managed across the healthcare system. For millions of women, this represents a long-overdue shift toward more effective, informed, and personalized care.
