Unboxing Menopause

In Menopause/Perimenopause by Stephanie Prendergast

It’s time for the FDA to remove the outdated and misleading boxed warning label on local vaginal estrogen.

75 million women in menopause are being held back by outdated and misleading FDA warnings on local vaginal estrogen—a proven, safe, and effective treatment for GSM symptoms like tissue thinning, painful sex, and recurrent UTIs.

Despite overwhelming support from scientific studies, this outdated boxed warning continues to restrict access to this essential treatment.

This isn’t just about removing a warning label—it’s about saving lives and improving women’s health. Women deserve accurate, evidence-based information that reflects the true safety of local vaginal estrogen.

What can you do? Join us in urging the FDA to remove this outdated and misleading warning by supporting the Unboxing Menopause campaign. Your voice can make a difference—find the appropriate link below to send a letter to the FDA! Let’s fight for the care all women deserve. 

Healthcare Professionals: Send a letter to the FDA now!

General Public: Send a letter to the FDA now!

 

What You Need to Know

  • Symptoms of GSM include increased UTIs, urinary incontinence, vaginal dryness, and pain with intercourse. GSM is chronic and “progressive”: it often gets worse as you age and does not go away without treatment.
  • Fortunately, there is a safe and effective treatment: local, vaginal estrogen,, which has been deemed safe and effective in multiple studies and is recommended by top menopause doctors and multiple medical societies.
  • However, women and medical providers are being deterred by an outdated “boxed” warning on local vaginal estrogen products, preventing clinicians from prescribing and women from using. If this boxed warning remains, women will continue to be undertreated for GSM.
  • Removing this label is not just a regulatory change, it’s a critical step toward saving women’s lives and improving their health outcomes by allowing access to safe and effective treatment.
  • Women deserve to have an accurate label on local vaginal estrogen that reflects the most recent evidence-based data.
  • Now is the time for the FDA to distinguish between local estrogen and systemic estrogen products.

(information sourced/shared directly from Let’s Talk Menopause)

 

Special thanks to Dr. Kelly Casperson, Dr. Rachel Rubin and This Is The Swell for their work in this campaign!

 

 

General Information About GSM/Menopause:

As people age, circulating hormones decline and pelvic floor dysfunction rises. The combination of these changes can cause unnecessary suffering and distress. The unfortunate news is that most people do not realize their symptoms may be related to hormonal deficiencies & musculoskeletal issues. However, the good news is both scenarios are treatable! Menopause can significantly impact pelvic health, leading to conditions such as urinary incontinence, pelvic organ prolapse, and sexual dysfunction. The reduction in estrogen levels can cause the pelvic floor muscles to lose elasticity and strength, making them less supportive of the organs they cradle.

Resources:

Find a certified menopause healthcare practitioner in your area

Further reading about menopause

Ask the Expert

 

Sources:

Vaginal estrogen use and chronic disease risk in the Nurses’ Health Study.

Breast Cancer, Endometrial Cancer, and Cardiovascular Events in Participants who used Vaginal Estrogen in the Women’s Health Initiative Observational Study

Menopause Society Position Statement

Check out this fact page for more information about Menopause!

 

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