The Menopause Society Comments on the FDA Announcement on Hormone Therapy
We agree with the FDA’s decision to remove the boxed warning on low-dose vaginal estrogen therapies used to treat genitourinary symptoms associated with menopause. The boxed warning may have been a deterrent to the use of the low-dose vaginal estrogen, which is a safe and effective therapy for a condition that affects most menopausal women. Systemic estrogen still comes with potential risks in certain individuals that should be reviewed in detail with women initiating therapy. As stated in The Menopause Society’s hormone therapy position statement, the risks are low for younger, healthy women initiating hormone therapy closer to the menopause transition. Risks are greater when initiated in older women and in those who are further from menopause onset. Medical comorbidities, personal and family histories, symptoms, and personal preferences all need to be reviewed with patients considering the use of hormone therapy for management of menopause symptoms or prevention of bone loss.

