What are you looking for?

The Power of a Black Box: Reclaiming Health for Millions of Women

Dec. 10, 2025

One month ago today, the U.S. Food and Drug Administration (FDA) made a landmark decision that is expected to significantly improve the quality of life for millions of women. The FDA removed the broad "black box" warnings from estrogen-containing products used for Hormone Replacement Therapy (HRT) and the Genitourinary Syndrome of Menopause (GSM).

For decades leading up to this moment, countless women nationwide were confused and often terrified by perceived risks of HRT. This led to a significant underutilization of medications that could substantially alleviate debilitating symptoms. The prior "black box" warnings particularly raised concerns that estrogen-containing products increased risks of cardiovascular disease, breast cancer, and probable dementia. In turn, many women silently endured symptoms like increased urinary frequency, urgency, recurrent urinary tract infections (UTIs), and painful intercourse – all greatly impacting their quality of life.

Virginia Mason Franciscan Health urologist/urogynecologist specializing in pelvic floor surgery Una Lee, MD, has been a vocal advocate alongside physicians, patients, and other women’s health organizations, helping to champion the re-evaluation of these warnings to ensure care could reach more women who need it.

Una Lee, MD
Una Lee, MD

“This critical change marks a defining moment in health care, when women’s health has been prioritized and recommendations are based on the best current medical evidence. By eliminating undue fear this will significantly improve the quality of care for women suffering from menopause-related symptoms and the local symptoms related to the Genitourinary Syndrome of Menopause,” noted Dr. Lee. “Not only will patients be reassured by the removal of the black box warning, but so will prescribing physicians who will face less barriers when recommending treatment.

A national study led by Dr. Lee underscored the issue: Among women who received a prescription for vaginal estrogen therapy, nearly 40 percent did not use it due to fear of side effects.

What current data shows

Vaginal Estrogen products typically include localized, low-dose treatment with minimal systemic absorption. Current data reviewed by the FDA clearly demonstrates the benefits of vaginal estrogen and/or HRT often outweigh the risks for most patients.

In fact, according to the Department of Health & Human Services, HRT has been associated with:

Further studies have found HRT was not associated with increased cancer mortality, and women who start HRT before age 60 appear to have a decreased overall mortality risk.

“The removal of the black box warning is a direct result of evidence-based advocacy championed by organizations such as the American Urological Association (AUA), Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction (SUFU), among other medical organizations and specialties, and importantly, supported by patients and clinicians,” Dr. Lee shared. “This important achievement demonstrates the power of collaborative, patient-focused advocacy.”

Where we go from here

Safety information for HRT will remain available to patients within product packaging, allowing for a personalized discussion of risks and benefits between a patient and their doctor.

It's important to note that for systemic estrogen-alone products (used by women who still have a uterus), the "black box" warning for endometrial cancer will be retained. For patients with a uterus taking systemic estrogen, their health care teams will continue to guide the most appropriate treatment plan and most likely prescribe progestin alongside the estrogen to counteract this specific risk.

The American Urological Association published new guidelines for GSM which are readily available for physicians to access, further supporting informed decision making. Dr Lee was the Vice Chair of these national clinical guidelines.

Dr. Lee sincerely hopes more women will feel empowered to speak up, be heard, and no longer suffer silently.

"One of the most rewarding aspects of my 20-plus year career is to hear women say, 'You helped me. You changed my life,’” said Dr. Lee.