HRT warning changes shift GSM care from fear to clarity

In this video, Sameena A. Rahman, MD, of Northwestern University Feinberg School of Medicine in Chicago, Illinois, discusses how the FDA’s removal of broad boxed warnings on systemic hormone replacement therapy (HRT) is reshaping conversations with patients experiencing genitourinary syndrome of menopause (GSM).

She explains that for years, counseling around HRT began from a defensive posture—clinicians had to counter fears rooted in misinterpretations of the WHI study before they could meaningfully address symptoms or treatment options. With the boxed warnings removed, she anticipates a shift from “fear to clarity,” allowing discussions to focus directly on individualized risk-benefit assessment rather than myth-busting. Rahman emphasizes that menopause care requires precision medicine rather than a one-size-fits-all approach, and the new labeling aligns better with how clinicians already interpret the evidence.

She believes these changes will indirectly improve acceptance of local estrogen or DHEA treatments for GSM. Although local therapies were never implicated in systemic risks, patients often encountered alarming boxed warnings on systemic products that created confusion and fear. This disconnect made it difficult for clinicians to reassure patients that local estrogen is safe, minimally absorbed, and essential for preventing recurrent urinary tract infections, vaginal discomfort, and other GSM complications.

Regarding women with GSM who also have cardiovascular or cognitive risk factors, Rahman says the revised FDA guidance reinforces the nuanced, individualized approach she already takes. She highlights the evidence that early initiation of systemic HRT can reduce cardiovascular and Alzheimer disease risk, though she clarifies that HRT is not prescribed solely for disease prevention. Instead, clinicians treat vasomotor symptoms, sleep disturbances, and bone loss, which may in turn influence long-term health trajectories. She stresses that patient-specific factors—such as ethnicity, metabolic risks, and symptom burden—remain central in determining whether and when systemic therapy is appropriate.