Cynthia Stuenkel, MD, Clinical Professor of Medicine at the University of California, San Diego and chair of the Endocrine Society’s recently published clinical practice guideline, Treatment of Symptoms of the Menopause, presented at a Food and Drug Administration (FDA) workshop on November 10 on potential changes to package labels for vaginal estrogen therapies. The North American Menopause Society (NAMS) published a commentary in the September 2014 issue of Menopause to encourage modifications to the product labeling of low-dose vaginal estrogen. Motivated by concerns of practicing clinicians that the Boxed Warning on the labels and package inserts for these products overstate potential risks and thus adversely affect patient care, leaders in the field spearheaded an effort to encourage consideration of alternative labeling that enhances patient safety by highlighting relevant cautions without a Boxed Warning.
In her testimony, Stuenkel proposed that women would be better served by a modified label that would state that while hormone therapies given systemically in higher doses have been linked to specific risks, it is unknown whether these concerns also apply to low-dose vaginal estrogen. Consistent with this, the Society’s Guideline states “available evidence does not support the boxed warning on low-dose vaginal estrogen regarding an increased risk of coronary heart disease, stroke, venous thromboembolic disease, dementia, and breast cancer, and efforts to modify the labeling of these products are in progress.”
The effort to change the product label is supported by the medical community and multiple provider organizations, including NAMS, American Congress of Obstetricians and Gynecologists, American Society for Reproductive Medicine, American Association of Nurse Practitioners, and Society for Women’s Health Research, among others. The Citizen’s Petition launched by NAMS received 630 signatures.
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