Local vaginal estrogen is an FDA-approved localized hormone therapy that comes in the form of a cream, ring, or tablet. It is directly absorbed through the vagina/vulva/urethra and can be used both as a preventative therapy and as a treatment for Genitourinary Syndrome of Menopause (GSM) which includes vaginal dryness, frequent UTIs, urinary discomfort, tissue decline, and painful sex/reduced orgasm.
Local vaginal estrogen is effective in treating the symptoms of GSM. Unlike Systemic Menopause Hormone Therapy/MHT (otherwise known as MHT/Hormone Replacement Therapy), it works at the source and specifically on GSM symptoms.
See here for more details; please consult with your medical provider for more information.
There is currently a “boxed warning” on all local vaginal estrogen products, which discourages clinicians from prescribing and deters women from using it. If this warning remains, women will continue to be undertreated for GSM.
Boxed warnings (formerly known as Black Box Warnings) are the strongest type of warning that the FDA can require for a drug and are generally reserved for alerting prescribers to adverse drug reactions that can cause serious injury or death.
In 2003, the FDA mandated a boxed warning on ALL estrogen products—regardless of whether systemic or locally administered—based on the 2002 Women’s Health Initiative (WHI) findings about Systemic Menopause Hormone Therapy. At the time, the FDA stated that they “don’t have the information to say that one or the other is different.”
The FDA has not changed the labeling since 2003, despite numerous new studies showing that local vaginal estrogen is safe. The Menopause Society filed a citizen petition in 2016 to change the labeling, which was rejected by the FDA in 2018.
WARNING: Cardiovascular disease, Stroke, Blood clots, Breast cancer, Endometrial cancer, Probable dementia, Pulmonary embolism, and Deep vein thrombosis (DVT)
Local vaginal estrogen is applied directly to the vaginal area, where it acts locally without significantly entering the bloodstream.
Multiple studies (link) have shown that local vaginal estrogen is safe. With this boxed warning, women and medical practitioners are deterred and scared away from taking this safe and effective preventative measure/treatment.
Changing this label is not just about removing a warning, it's about saving lives and improving health outcomes. Women deserve to have an accurate label on local vaginal estrogen that reflects the true risk based on the most updated and accurate evidence-based data.
Healthcare Clinicians play a crucial role in advocating for the removal of the boxed warning on local vaginal estrogen products. By educating your patients and advocating for evidence-based labeling, you can help ensure that women receive the most appropriate and effective treatments for GSM.
MEDICAL ADVICE DISCLAIMER:
This information is intended for informational purposes only, not as a substitute for professional medical advice, diagnosis, or treatment. Reliance on any of this information is solely at your own risk. Always seek the advice of a qualified healthcare provider with any questions you may have regarding a medical condition or treatment and before undertaking a new healthcare regimen. Never disregard professional medical advice or delay seeking advice because of something you have read here.
Let's Talk Menopause does not endorse any particular product, brand, or service.
Vaginal estrogen use and chronic disease risk in the Nurses’ Health Study.
