A panel of experts, convened by the FDA, has discussed the growing consensus that the boxed warning label on menopausal hormone therapies is outdated or inappropriate. The discussion comes after a landmark development in urology – the release of guidelines for genitourinary syndrome of menopause (GSM) from the American Urological Association.
Ashley G. Winter, MD, a urologist, expressed hope that ongoing FDA discussions and expert advocacy will lead to the removal of the warning label. She believes that hormone therapies are essential for comprehensive management of patients with low hormone states, particularly in relation to recurrent urinary tract infections, microscopic hematuria, overactive bladder, and nocturia.
Data from the Women’s Health Initiative (WHI) study has shown that low-dose vaginal estrogen is safe across several studies. However, Winter emphasized the importance of distinguishing between systemic hormone therapy and local vaginal estrogen therapy. She called on the FDA to revise the warning label for low-dose vaginal estrogen to better reflect current evidence.
The revised warning label aims to improve clinician and patient confidence in this treatment option, addressing a major barrier to patient compliance. With ongoing discussions and expert advocacy, Winter hopes that the FDA will take action to remove the outdated warning labels on hormone therapies.
Source: https://www.urologytimes.com/view/ashley-winter-md-calls-for-label-update-on-low-dose-vaginal-estrogen