The U.S. Food and Drug Administration is considering removing controversial black box warnings from vaginal estrogen treatments after medical experts recently told the agency that the labels are scaring millions of menopausal women away from effective care based on outdated science.
Urologist and sexual health expert Dr. Rachel S. Rubin was among several doctors and researchers who pleaded with the FDA on July 17 to remove vaginal estrogen’s black box warning—the strictest caution the agency places on pharmaceuticals—and eliminate the fear factor in what they say is an effective treatment for vaginal dryness and infection risk in genitourinary syndrome of menopause.
