After nearly two decades, a major shift is underway in how hormone therapy (HT) is perceived and prescribed for menopausal women. The Food and Drug Administration (FDA) has initiated the process of removing the controversial “black box” warning — the agency’s most serious safety alert — from all forms of HT. This decision, met with both relief and cautious optimism within the medical community, stems from a reevaluation of earlier data that led to the initial warning’s implementation.
Decades Under Cloud: The History of Black Box Warnings on Hormone Therapy
In 2002, the Women’s Health Initiative (WHI) published findings from a large clinical trial suggesting that HT increased the risk of heart attacks, strokes, and breast cancer. This spurred the FDA to issue the black box warning for estrogen products in 2003, casting a long shadow over HT usage. Consequently, hormone therapy prescriptions plummeted dramatically.
However, cracks began appearing in this narrative. Subsequent research identified flaws in the WHI study design, revealing that it focused primarily on older women with pre-existing health conditions, skewing the results. In 2024, the original WHI authors even published a follow-up analysis concluding that for healthy women experiencing menopause, the benefits of HT generally outweigh its risks.
Despite this evolving understanding, the black box warning persisted, leaving many women wary of seeking effective relief from menopausal symptoms. “The lingering stigma associated with the label,” says Mary Jane Minkin, MD, a clinical professor of obstetrics and gynecology at Yale School of Medicine, “often dissuades patients from exploring hormone therapy as a viable option.”
A New Chapter: FDA’s Reasoning and Medical Response
Dr. Martin Makary, FDA Commissioner, emphasizes the agency’s intent to move away from “fear-based” medical decisions, stating, “For too long, issues of women’s health have been under-recognized.” The FDA is now aiming to reflect a more nuanced understanding of HT risks and benefits by removing references to cardiovascular disease, breast cancer, and dementia risks from product labeling.
While Dr. Makary champions this change as crucial for empowering women, some physicians express concern over the broader scope of the decision, particularly regarding systemic hormone therapy. They advocate for further research before fully lifting the black box warning on these formulations. “Systemic HT, while generally safe, can have nuanced risks depending on individual factors,” notes Lauren Streicher, MD, a clinical professor of obstetrics and gynecology at Northwestern University Feinberg School of Medicine.
### Looking Ahead: A Shift in Focus
The FDA’s move signals a potential paradigm shift in how menopausal health is approached. It reflects growing recognition that individualized risk-benefit assessments are essential, replacing blanket warnings with tailored guidance. The coming months will likely see ongoing discussions and adjustments as healthcare providers, researchers, and regulatory bodies work to ensure the safest and most effective use of hormone therapy for women navigating menopause.
The FDA expects companies to implement these label changes within six months.
