Ashley Winter, MD, on the impact of the boxed warning on estrogen-containing products

On July 17, 2025, a panel of experts convened by the FDA voiced growing consensus that the boxed warning on menopausal hormone therapies, particularly low-dose vaginal estrogen, is an outdated or inappropriate representation of the risks.

In a recent interview with Urology Times®, Ashley G. Winter, MD, a board-certified urologist in Los Angeles, California, discusses the real-world impact of this boxed warning label on patient care and counseling.

“Right now, it is our counseling against the warning label,” she emphasized.

Winter stressed that for many women, lack of appropriate treatment can have life-or-death consequences—such as the risk of developing urosepsis or antimicrobial resistance in patients with urinary tract infections. Yet the boxed warning on estrogen-containing products puts patients in a difficult position—forcing them to choose between heeding a government-issued warning or trusting their physician’s expertise.

“I have to say to them, point blank, when you fill this prescription, there will be a black box warning in the label, and that is not evidence based,” Winter explained. “They have to put profound trust in me, because I am saying this is a label issued by the US government and our regulatory bodies, and I'm telling you not to believe it. That is a really tough sell, but it is life or death.”

REFERENCE

1. FDA expert panel on menopause and hormone replacement therapy for women. YouTube: US Food & Drug Administration. July 17, 2025. Accessed July 29, 2025. https://www.youtube.com/watch?v=_2ZRlOivC5M