Statement on FDA’s revocation of black box warnings on estrogen-based menopausal hormone therapy products
As a leading voice for midlife women’s health, HealthyWomen recognizes the important step the FDA has taken to increase access to hormone therapy (HT) products for women with perimenopausal and menopausal symptoms by changing the black box warnings for estrogen products.
Since 2003, the black box warning about low-dose vaginal estrogen products has had a chilling effect on patients and physicians alike, undermining the use of this proven treatment for genitourinary syndrome of menopause. HealthyWomen is proud to have joined many other women’s health organizations in calling for the removal of this black box warning on low-dose vaginal estrogen products. The evidence for the safety and effectiveness of low-dose vaginal estrogens is compelling, and HealthyWomen welcomes the FDA’s move to align drug labeling with current scientific evidence.
Regarding systemic hormonal therapies, which are more easily absorbed into the bloodstream and have a different safety profile than vaginal estrogen, HealthyWomen will continue to encourage patients to consult with their healthcare providers to determine the best treatment for their menopausal journey.
Overall, HealthyWomen applauds these proven measures to improve women’s care and remains true to its mission of educating women to make informed health decisions, advocate for themselves, and prioritize their health and well-being.
Additional reading:
- FDA announces changes to hormone therapy labeling
- HealthyWomen’s public comment on the black box warning on low-dose vaginal estrogen
- HealthyWomen Social Media
Resources
Everything you ever wanted to know about vaginal estrogen
Further research shows that vaginal estrogen is safe for people with a history of breast cancer
