Washington State Urology Society (WSUS) Press Release
Washington State Urology Society (WSUS) Member AnnouncementMajor Victory for Women’s Health: FDA Removes Black Box Warning from Estrogen-Containing ProductsSEATTLE, WA – November 10, 2025 – The Washington State Urology Society (WSUS) is pleased to announce a landmark decision by the U.S. Food and Drug Administration (FDA) to remove the broad “black box” warnings from many estrogen-containing products used for Menopause Hormone Therapy (MHT), also known as Hormone Replacement Therapy (HRT) and Local Vaginal Estrogen Therapy. This action applies directly to most estrogen-containing products approved for menopause treatment. This includes:
Systemic estrogen-alone products
Combined estrogen and progestogen products
Local vaginal estrogen products (which have been specifically cited as having minimal systemic absorption and low associated risk) which are used to treat moderate to severe symptoms of vulvar and vaginal atrophy associated with menopause
This critical change marks a monumental step forward in eliminating undue fear surrounding these therapeutic options and will significantly improve the quality of care for countless women suffering from symptoms of Menopause and/or the Genitourinary Syndrome of Menopause (GSM). The FDA is working with drug manufacturers to remove the black box warnings that cite increased risks of cardiovascular disease, breast cancer, and probable dementia for menopausal HRT products (including systemic and local vaginal estrogens). The original black box warning, implemented in the early 2000s, was based on an overbroad and often misreported interpretation of the Women's Health Initiative (WHI) study. The overall safety information will now be moved to the text of the package insert, allowing for a personalized discussion of risks between a patient and their doctor, rather than a "one-size-fits-all" blanket warning. What warnings will remain? The FDA is not seeking to remove the boxed warning for endometrial cancer for systemic estrogen-alone products (those taken by women who still have a uterus).
Endometrial Cancer: For systemic estrogen-alone products, the "black box" warning for the risk of endometrial cancer will be retained. This is because using estrogen alone can increase the risk of cancer in the lining of the uterus in women who have not had a hysterectomy. Progestin is typically added to counteract this risk.
This change is intended to align product labeling with modern scientific evidence, which suggests a more favorable benefit-risk profile for women who start MHT when they are younger (under 60) or within 10 years of the onset of menopause. The goal is to encourage a more nuanced discussion between patients and their healthcare providers and shared decision making. Urologic Leadership and Advocacy: A Collaborative VictoryThe removal of the black box warning is a direct result of evidence-based advocacy championed by many including the American Urological Association (AUA), Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction (SUFU), many other medical organizations and specialties, and supported by patients and clinicians. This monumental achievement demonstrates the power of collaborative, patient-focused advocacy. Many members of the Washington State Urology Society (WSUS) actively supported this initiative, recognizing the clinical need to eliminate this barrier to care. The AUA GSM Guidelines Panel and others successfully demonstrated to the FDA the compelling evidence confirming the safety and efficacy of low-dose vaginal estrogen therapy, particularly when used to treat localized urological symptoms of menopause. Positive Impact on Patient Care and GSM ManagementThe presence of the black box warning often deterred both physicians and patients from initiating effective local treatment, despite the localized nature and minimal systemic absorption of these low-dose products. The GSM symptoms—including urinary frequency, urgency, recurrent urinary tract infections (UTIs), and painful intercourse (dyspareunia)—can negatively impact a patient's quality of life. This barrier was documented in recent urological research. A national study led by Dr. Una Lee showed that among women who received a prescription for vaginal estrogen therapy, nearly 40% did not use it due to fear of side effects, with moderate-to-severe concern specifically cited regarding the risks listed on the package insert (Experiences With Genitourinary Syndrome of Menopause and Barriers to Vaginal Estrogen Usage Reported by a National Sample of 1500 Women - PubMed) . The removal of the black box warning will directly address this documented barrier and help reassure patients regarding safety. WSUS encourages all members to review the established clinical standards:
These guidelines provide the best clinical evidence for the diagnosis and management of GSM, emphasizing that localized, low-dose estrogen therapy remains a cornerstone of treatment. The safety of local low-dose vaginal estrogen therapy has been established and shown in numerous high-quality long-term studies. Local Recognition We are especially proud of the Washington State representation that contributed to this historic announcement. Urologist and Sexual health expert Rachel Rubin, MD spoke at the November 10th FDA and Health and Human Services press conference on behalf of the AUA, and Washington State Urologist, Podcaster, and Author Kelly Casperson, MD also presented her perspective, powerfully advocating for the positive impact this change will have on the diagnosis and treatment of GSM. Washington urologist and WSUS Past-President and Women’s Health Committee Chair Una Lee,MD serves as Vice Chair of the AUA Guideline on the Genitourinary Syndrome of Menopause and has championed this advocacy work through patient-centered research. Washington urologists Sabrina Stair, MD, Cristi Palmer, DO, and Van Ginger, MD spoke at the 2025 WSUS Annual Meeting on GSM, sharing practical clinical guidance. Society of Women in Urology Past President Suzette Sutherland, MD discussed this during a Backtable Urology podcast Dr. Suzette Sutherland on the BackTable Urology Podcast Many Washington urologists supported this advocacy effort by signing the ‘Unboxing Menopause” petition Unboxing Menopause | Let's Talk Menopause that was emailed out to all WSUS members. This change will significantly benefit all Washington State urologists in allaying patients’ fears associated with local hormonal treatment of GSM and prevention of recurrent UTIs, More information Members are encouraged to watch the full press conference detailing the advocacy efforts and the implications of this decision:
The FDA has a podcast discussing removal of black box warnings for HRT
FDA Direct: Removing Black Box Warnings for HRT (Part 1/2) FDA Direct: Removing Black Box Warnings for HRT (Part 2/2) The WSUS is proud to support its members and their advocacy efforts. Collaborative work from many passionate advocates has resulted in this tremendous and historic achievement which will positively impact millions of women. The WSUS remains committed to the urologic community, advocacy, and advancing the highest standard of urological care for all patients.
