As a leading voice in women’s midlife health, HealthyWomen recognizes the important step taken by the FDA to improve access to hormone therapy (HT) products for women experiencing perimenopausal and menopausal symptoms by modifying the black box warning labels for estrogen products.
Since 2003, the blackbox warning on low-dose vaginal estrogen products has had a chilling effect on patients and clinicians alike, undermining the use of this proven treatment for genitourinary syndrome of menopause. HealthyWomen is proud to have called for the removal of this blackbox warning on low-dose vaginal estrogen products alongside many other women’s health organizations. The evidence in favor of the safety and efficacy for low-dose vaginal estrogen is robust, and HealthyWomen celebrates the FDA’s move to align medication labeling with current scientific evidence.
Regarding systemic hormone therapies, which are more readily absorbed into the bloodstream, and have different safety profiles than vaginal estrogen, HealthyWomen will continue to encourage patients to connect with their healthcare providers to determine the best treatment for their menopause journey.
Overall, HealthyWomen commends this demonstrated action to improve care for women and remains steadfast in its mission to educate women to make informed health decisions, to advocate for themselves and to prioritize their health and wellness.
Additional Reading:
- FDA Hormone Therapy Labeling Changes Announcement
- HealthyWomen Public Comment Letter on Blackbox Warning on Low-Dose Vaginal Estrogen
- HealthyWomen Social Media
Resources
Everything You Ever Wanted to Know About Vaginal Estrogen
More Research Shows Vaginal Estrogen Is Safe for People with a History of Breast Cancer