Support the Unboxing Menopause Campaign
It’s time for the FDA to remove the outdated and misleading boxed warning label on local vaginal estrogen. Let’s Talk Menopause has created a turnkey advocacy campaign to support the “Unboxing Campaign.”
- 75 million women are in perimenopause, menopause, or postmenopause with 6,000 more reaching menopause each day.
- Women are not getting the treatment they need or deserve for the extremely common Genitourinary Syndrome of Menopause (GSM).
- 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- However, women and medical providers are being deterred by an outdated “boxed” warning on local vaginal estrogen products, preventing clinicians from prescribing and women from using.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.