FDA Removes Black Box Warning on Menopausal Hormone Therapy: Implications for Urologic and Sexual Health

Center for Advanced Urology — New Jersey

A Major Change in Women’s Health

The FDA has officially removed the long-standing black box warning from over 20 estrogen-based and combination hormone therapies. This reflects modern evidence showing hormone therapy is safe and effective for many women, especially those under 60 or within 10 years of menopause.

Hormone Therapy and Urologic Health

Declining estrogen significantly impacts urinary and pelvic function, contributing to:
- Overactive bladder
- Urgency and frequency
- Recurrent urinary tract infections
- Genitourinary Syndrome of Menopause (GSM)
- Pelvic floor weakening
- Sexual dysfunction

Updated FDA Guidance

- Removal or revision of boxed warnings related to cardiovascular and dementia risks.
- Remaining boxed warning applies only to unopposed estrogen in women with a uterus.
- Emphasis on timing: earlier therapy yields better outcomes.

The Science Supporting Hormone Therapy

Benefits include:
- Improved bladder and pelvic floor health
- Reduced UTIs by 50–70%
- Restored vaginal elasticity and lubrication
- Enhanced sexual function
- Improved bone, heart, and cognitive health

Who May Benefit

Women experiencing:
- Recurrent UTIs
- Urgency or incontinence
- Painful intercourse
- Vaginal atrophy
- Pelvic discomfort
- Low libido

Our Approach at Center for Advanced Urology

- Comprehensive evaluation
- Advanced bladder testing
- Hormonal assessment
- Local or systemic hormone therapy
- Non-hormonal alternatives
- Collaborative care

Take Control of Your Urologic Health

If you’re experiencing urinary or sexual symptoms, we can help.

Visit: www.centerforadvancedurology.com
Call: (856) 983-5451