The Truth About Vaginal Estrogen and the FDA Black Box Warning: What Every Woman Should Know

Genitourinary Symptoms of Menopause (GSM): A Silent Epidemic

Did you know that 50%–90% of postmenopausal women experience GSM—a group of chronic, progressive symptoms affecting genital, sexual, and urinary health? These symptoms can have a profound impact on quality of life, but less than 25% of women ever discuss them with their healthcare provider.

Why Aren’t More Women Getting Help?

One major barrier: confusion and fear about treatment options, especially local vaginal estrogen. Since 2003, the FDA has required a “black box” warning on all estrogen products—regardless of the dose or delivery method. This warning, intended to highlight serious risks, is the same for both high-dose systemic estrogen and tiny-dose local vaginal estrogen. As a result, many women and even healthcare providers are hesitant to use or prescribe these effective, evidence-based treatments.

What Is a “Black Box” Warning—And Why Does It Matter?

A “black box” warning is the FDA’s strongest safety alert for prescription medications. It’s designed to call attention to very serious risks. But when this warning is applied to all estrogen products—regardless of type or dose—it overstates the risks of low-dose vaginal estrogen.

• Systemic estrogen (pills, patches, creams) affects the whole body and may have broader risks and benefits.

  
  

• Local vaginal estrogen is a minuscule dose, used just in the vaginal area, and does not significantly raise blood estrogen levels.

  
  

The Science Is Clear: Local Vaginal Estrogen Is Safe for Most Women

Research shows that local vaginal estrogen does not increase the risk of stroke, blood clots, or dementia. In fact, it can help prevent urinary tract infections, relieve pain, and restore comfort and intimacy for women struggling with GSM. The risks listed in the FDA’s black box warning simply don’t reflect the reality for these products.

Why Is This Important?

Women are missing out on safe, effective relief. Fear of the black box warning keeps many from seeking or accepting treatment—leaving them to suffer with symptoms like urinary frequency, pain, recurrent infections, and sexual discomfort.

Advocacy in Action: Working to Update the Warning

In 2023, Let’s Talk Menopause and the Menopause Advocacy Working Group—alongside leading experts like Dr. Rachel Rubin—began working directly with the FDA to address this issue. Their goal: ensure that medication labels accurately reflect the true risks and benefits, so women and providers can make informed decisions.

What’s Next?

The advocacy group is collaborating with the FDA and industry partners to find a path forward. Public awareness is essential—by sharing accurate information, we can help more women access the care they deserve.

What Can You Do?

• If you’re experiencing GSM symptoms, talk to your provider—safe, effective treatments are available.

• Learn more about the advocacy efforts and support the campaign to update the FDA warning.

• Share this information with friends and family to help break the stigma.

  
  

At Follaine Health, we’re committed to providing evidence-based, individualized care for women at every stage of menopause. If you have questions or want to explore your treatment options, book a free discovery call with our team today.

Key Research & Position Statements

1. The 2022 NAMS Position Statement: The 2022 Hormone Therapy Position Statement of The North American Menopause Society

   • Summary: NAMS states that low-dose vaginal estrogen is effective for genitourinary symptoms of menopause and does not increase the risk of breast cancer, endometrial cancer, cardiovascular events, or dementia.

   • Reference:

     
     

     The North American Menopause Society. The 2022 hormone therapy position statement of The North American Menopause Society. Menopause. 2022;29(7):767-794.

     
     

     Read summary

2. ACOG Practice Bulletin No. 141: Management of Menopausal Symptoms

   • Summary: The American College of Obstetricians and Gynecologists (ACOG) supports the use of low-dose vaginal estrogen for GSM and notes its safety, even in women with a history of breast cancer (with oncologist input).

   • Reference:

     
     

     American College of Obstetricians and Gynecologists. Practice Bulletin No. 141: Management of Menopausal Symptoms. Obstet Gynecol. 2014;123(1):202-216.

     
     

     Read summary

3. FDA Drug Safety Communication: FDA updates label for vaginal estrogen products

   • Summary: The FDA has acknowledged ongoing review and updates to labeling for vaginal estrogen products, with ongoing advocacy from medical groups.

   • Reference:

     
     

     U.S. Food & Drug Administration. FDA Drug Safety Communication: FDA updates label for vaginal estrogen products.

     
     

     FDA Communication

4. Simon JA, et al. Local Estrogen Therapy for Genitourinary Syndrome of Menopause: A Review of Efficacy and Safety

   • Summary: Review of evidence supporting the safety and efficacy of local (vaginal) estrogen therapy for GSM.

   • Reference:

     
     

     Simon JA, et al. Local Estrogen Therapy for Genitourinary Syndrome of Menopause: A Review of Efficacy and Safety. Menopause. 2018;25(8):906-913.

     
     

     PubMed Abstract

5. Pinkerton JV, et al. Safety and Efficacy of Local Estrogen Therapy for GSM: A Systematic Review

   • Summary: Systematic review confirming that local vaginal estrogen does not increase the risk of endometrial hyperplasia, cancer, cardiovascular disease, or VTE.

   • Reference:

     
     

     Pinkerton JV, et al. Safety and Efficacy of Local Estrogen Therapy for GSM: A Systematic Review. Climacteric. 2020;23(4):337-343.

     
     

6. Interview with Dr. Rachel Rubin, Urologist & Sexual Medicine Specialist

7. The Menopause Advocacy Working Group