Vaginal Estrogens, The Black Box Warning and You
I was in Rite Aid the other day searching for band aids. The first aid care section is right next to the pharmacy window (nothing awkward there) where a woman was telling the pharmacy tech how excited she was for her new estrogen for “down there.” Since it was a new prescription, she had to talk to the pharmacist who handed her what looked like a huge print out of information and said, “Before I explain how to use this, please know there is a black box warning on it for cancer.”
I walked away. I had found my band aids and knew what would come next. It’s also not the first time I had witnessed or heard something similar having been in practice for as long as I was and talked to as many pharmacists as I did.
The low-dose vaginal estradiol warning is insane and it starts out front and center like this:
🚨WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, BREAST CANCER and PROBABLE DEMENTIA🚨
No wonder women absolutely FREAK out. 😫
What’s The Truth?
The truth is, that’s not the truth. The black box warning should not be on low-dose vaginal estrogens.
In July of 2025, a review article came out that looked at 7 articles. Their conclusion was “Vaginal estrogen therapy appears to be safe in the management of menopausal genitourinary syndrome in breast cancer survivors and it is related to significantly lower all-cause mortality.”
Review articles can be helpful as they collate the data that’s out there and pull it together.
However, even large organizations such as the Menopause Society Guidelines and the American Urological Association Guidelines state low-dose vaginal estradiol appears to be safe. It does not increase the risk of endometrial cancer, cardiovascular disorders, breast cancer or probably dementia. 🙌
Low-dose vaginal estrogen therapy is VERY different from the many types of systemic hormone therapy available for use. Unfortunately, since 2003 due to the Women’s Health Initiative study, the FDA felt differently and labeled all estrogen products as the exact same as far as their warnings go.
What About Now?
We’ve come a long way! An FDA panel convened in July 2025 and it looks like the black box warning for low-dose vaginal estrogen products may go away. Yay! 🤩
I say this excitedly because I would hate for you to make a decision NOT to use the product out of misplaced fear. We’ve come a long way since 2003!
Vaginal estradiol is FDA approved for vulvovaginal atrophy, thinning, dryness, pain, and/or inflammation of the internal and external tissues. While technically it’s not approved (yet) for the entire scope of genitourinary syndrome of menopause, it is wildly helpful! This could include, pelvic floor issues and bladder and urethral issues too.
Pain with sex? Dry and itchy? Urinary tract infections? Vaginal infections? Urinary leakage? Vaginal estrogen might really really help.
And while you always have to talk with your practitioner, it seems you can do it if you have had breast cancer too.
So, I understand the why for that black box warning back in 2003. However, it’s time to they with the new research, recommendations and guidelines!