madman
Super Moderator
Ashley Winter, MD, calls for label update on low-dose vaginal estrogen
"We are not offering patients comprehensive management unless we consider hormone therapies," says Ashley G. Winter, MD.
"We are not offering patients comprehensive management unless we consider hormone therapies," says Ashley G. Winter, MD.
On July 17, 2025, a panel of experts convened by the FDA outlined the growing consensus that the boxed warning label on menopausal hormone therapies, particularly low-dose vaginal estrogen, is an outdated or inappropriate representation of the risks. This discussion came on the heels of a landmark development in urology—the release of the American Urological Association’s first guidelines on genitourinary syndrome of menopause (GSM).
In a recent interview with Urology Times®, Ashley G. Winter, MD, recapped key points from the FDA panel discussion on the boxed warning label for menopausal hormone therapies. Specifically, she called the warning a major barrier to patient compliance and expressed hope that ongoing FDA discussions and expert advocacy will lead to its removal.
She explained, “Over the years, being a urologist, I came to realize that so many of the things that we were seeing in our patients—whether it was recurrent urinary tract infections, microscopic hematuria, overactive bladder, or nocturia in women around the time of the menopause transition or beyond—was actually related to a low hormone state. We are not offering patients comprehensive management unless we consider hormone therapies.”
According to Winter, data from the Women’s Health Initiative (WHI) study, which initially led to the class-wide warning label on all estrogen products, should be considered in context and not applied broadly to all forms of hormone therapy. She emphasized the importance of distinguishing between systemic hormone therapy and local vaginal estrogen therapy, noting that low-dose vaginal estrogen has been shown to be safe across several studies.
“What's important is that observational and WHI-based data from 1000s of women has shown that low-dose vaginal hormone preparations, the type used to treat GSM, has never been associated with any of those things—has not been associated with breast cancer, blood clots, endometrial cancer, [or] dementia. It is profoundly safe,” Winter said. “A big hold up to actually acting and getting patient compliance in this treatment domain is the black box warning.”
To that point, Winter called on the FDA to revise the warning label for low-dose vaginal estrogen to better reflect the current evidence and improve clinician and patient confidence in this treatment option.
