A Significant Advancement in Women’s Health: FDA Reassesses Black Box Warnings on Menopause Hormone Therapy
In July, an expert panel convened with the U.S. Food and Drug Administration (FDA) to advocate for the removal of black box warnings on menopause hormone therapy (MHT) and to discuss the clinical need for an FDA-approved testosterone formulation for women.
This request represented a pivotal step forward, as MHT remains underutilized despite substantial evidence supporting its safety and efficacy when initiated within ten years of menopause onset or before age 60. The underuse of MHT continues to deprive millions of women of its well-documented benefits.
Today, the FDA announced its recommendation that manufacturers remove the black box warnings from multiple forms of MHT. This decision follows a comprehensive reassessment of numerous studies demonstrating that, for most women, the benefits of initiating hormone therapy within a decade of menopause outweigh the potential risks.
Current evidence indicates that appropriately timed MHT is associated with:
• Reduced all-cause mortality
• Lower fracture risk
• A 50% reduction in myocardial infarction risk
• A 64% reduction in cognitive decline
• A 35% lower risk of Alzheimer’s disease
This FDA action represents a meaningful advancement in addressing barriers to optimal women’s healthcare. However, ongoing challenges remain.
Future priorities include:
• Revising medical education curricula to ensure healthcare providers receive comprehensive training in the management of perimenopausal and menopausal patients.
• Advancing regulatory approval of testosterone therapy for women, ensuring access to standardized, evidence-based treatment options.
Together, these developments represent significant progress toward a more equitable and informed approach to women’s health throughout the menopausal transition and beyond.
Written by Jean Walker / WHNP
