Why the Product Labeling for Low-Dose Vaginal Estrogen Should Be Changed

JoAnn E. Manson, MD, DrPH, NCMP; Steven R. Goldstein, MD, NCMP; Risa Kagan, MD, NCMP; Andrew M. Kaunitz, MD, NCMP; James H. Liu, MD; JoAnn V. Pinkerton, MD, NCMP; Robert W. Rebar, MD; Peter F. Schnatz, DO, NCMP; Jan L. Shifren, MD, NCMP; Cynthia A. Stuenkel, MD, NCMP; Margery L.S. Gass, MD, NCMP; Wulf H. Utian, MB Bch, PhD, DSc(Med)


Menopause. 2014;21(9):911-916. 

In This Article


This commentary summarizes the activities of several clinicians and researchers to encourage modifications to the 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 are spearheading an effort to encourage consideration of alternative labeling, as discussed below. The members of the Working Group on Women's Health and Well-Being in Menopause have affiliations with a number of medical societies, including The North American Menopause Society, the American College of Obstetricians and Gynecologists, the Endocrine Society, the American Society for Reproductive Medicine, the International Society for the Study of Women's Sexual Health, and other professional organizations. We appreciated the opportunity to share our concerns, literature review, and proposal for alternative labeling with members of the US Food and Drug Administration (FDA) Division of Bone, Reproductive, and Urologic Products via a teleconference earlier this year. We encourage further consideration of our rationale and proposal by both the FDA and the pharmaceutical companies that own these products.