Experts recommend change in labeling for low-dose vaginal estrogen

As more post menopausal women change to a low dose local vaginal estrogen to control vaginal atrophy, a group of experts have recommended that the FDA modify the package Black Box Warning label  on the product packaging.  The current warning is based on research done mainly on oral estrogen which is a systemic rather than local therapy.   The local low-dose therapy, in fact, was designed to reduce estrogen exposure to the woman while still providing localized (vaginal) relief from vaginal atrophy.   The panel of experts who wrote the editorial published in the journal Menopause, believe that the current warning is not based on this form of the estrogen and is harming women by discouraging their use of this very effective product that could improve their quality of life and prevent some serious health problems.

Vulvovaginal atrophy (VVA) is a common and progressive condition that is due to the lack of estrogen during and after the menopause.  This results in  the  thinning, drying and inflammation of the vaginal walls that can lead to painful sex and urinary disorders.   Localized estrogen is an approved treatment for this disorder.   To read more about menopause and the latest evidence based treatment options, visit a site developed by the Women’s Health Research Institute at Northwestern University.