Is one outdated warning label standing between millions of women and safe, effective care? In this episode of BackTable Urology, Dr. Yahir Santiago-Lastra, a urologist specializing in female pelvic medicine and reconstructive surgery at UC San Diego, joins host Dr. Suzette Sutherland to discuss the black box warning on vaginal estrogen, its historical context, and the ongoing advocacy efforts to update outdated FDA guidelines.

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SYNPOSIS

The conversation covers the importance of low-dose vaginal estrogen in treating genitourinary syndrome of menopause (GSM), the fear surrounding hormone therapy due to misinterpreted data from the Women's Health Initiative (WHI) study, and the inequities faced in women's health, particularly in the context of hormone replacement therapies. They discuss the legislative and advocacy strategies needed to enact change, emphasizing the role of professional societies, legislative efforts, patient advocacy, and industry support in overcoming the barriers to updating the black box warning.

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TIMESTAMPS

00:00 - Introduction
03:43 - History Behind the Estradiol Black Box Warning
13:44 - The FDA Citizen Petition
18:18 - Gender Inequity in Medicine
24:05 - The Role of Organizational Guidelines in Patient Advocacy
28:51 - Vaginal Estrogen for Genitourinary Syndrome of Menopause (GSM)
32:57 - Medicare Spending and Legislative Advocacy
44:56 - Recap and Future Directions

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RESOURCES

(TRAVERSE Trial) Cardiovascular Safety of Testosterone-Replacement Therapy
https://www.nejm.org/doi/full/10.1056/NEJMoa2215025

Systemic or Vaginal Hormone Therapy After Early Breast Cancer: A Danish Observational Cohort Study
https://doi.org/10.1093/jnci/djac112

(ASCO Study) Use of local estrogen therapy among breast cancer patients in SEER-MHOS database
https://doi.org/10.1200/JCO.2025.43.16_suppl.578

Vaginal estrogen use in breast cancer survivors: a systematic review and meta-analysis of recurrence and mortality risks
https://doi.org/10.1016/j.ajog.2024.10.054