HJAR Jan/Feb 2026

HORMONE THERAPY strengthened, the gap between scientific understanding and FDA labeling grew increasingly problematic. The boxed warn- ing, originally intended to draw attention to safety concerns, no longer reflected con- temporary data or clinical best practices. More importantly, it contributed to ongo- ing provider hesitation, restricted access to care, and persistent misinformation among patients. In response, the FDA convened a round- table of leading experts in menopause, endocrinology, cardiology, urology, oncol- ogy, and women’s health to reevaluate the risks and benefits of estrogen therapy. The discussion centered on current evidence and meta-analysis rather than early, incom- plete interpretations of the WHI. Experts highlighted: • The timing hypothesis showing that risks differ significantly when therapy is initiated within 10 years of meno- pause versus later in life. • The favorable safety profile of estro- gen-only therapy, including long-term reductions in breast cancer incidence. • The importance of route and dose, with transdermal and lower-dose therapies carrying reduced thrombotic risk. • The clinical harms of undertreatment, including persistent vasomotor symp- toms, accelerated bone loss, sleep dis- ruption, mood disturbance, and pro- gression of genitourinary syndrome of menopause. • The safety and efficacy of vaginal estrogen as it is a local therapy and very little enters the bloodstream. Following this comprehensive review, the FDAdetermined that the boxed warning on estrogen products was no longer aligned with the totality of evidence. In November, the agency removed the boxed warning, signaling an important shift toward a more accurate and evidence-based understanding of hormone therapy safety. This decision represents more than a regulatory update — it acknowledges the past misinterpretations, affirms the current science, and supports clinicians in offering effective, individualized care. For providers, it also serves as a reminder of the respon- sibility we hold to remain current, engage with emerging evidence, and ensure that women are no longer denied safe, effective treatment because of outdated fears. What the Removal of the Boxed Warning Means for Clinical Practice The FDA’s decision to remove the boxed warning on estrogen therapy signals a long- awaited alignment between regulatory lan- guage and contemporary evidence. For cli- nicians, this shift has practical implications. First, it restores confidence in prescribing estrogen for the many patients who stand to benefit — particularly healthy women under 60 or within 10 years of menopause onset, where the benefit–risk profile is most favor- able. Second, it clarifies distinctions that often caused confusion: estrogen-only ther- apy carries different risks than combined therapy; transdermal delivery eliminates thrombotic risk; and timing of initiation is critical in shaping outcomes. Finally, the removal helps reduce the stigma that has persisted around hormone therapy, opening the door to more nuanced and individual- ized patient counseling. Instead of navigat- ing conversations constrained by outdated warnings, clinicians can now rely on cur- rent guidelines, robust data, and shared decision-making to tailor therapy to each woman’s needs and goals. Why Provider Training in Menopause Care Is More Important Than Ever As regulatory guidance catches up to the science, the need for provider educa- tion becomes increasingly clear. Decades of undertraining in menopause medicine have left many clinicians uncertain about how to evaluate symptoms, assess risk factors, or choose among formulations and routes of “The removal of the boxed warning marks a pivotal moment in the evolution of menopause care — one that invites us, as clinicians, to reconsider long- held assumptions and reaffirm our commitment to evidence-based practice.”