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December 2017

Compounded Bioidentical Hormone Therapy: Does the Regulatory Double Standard Harm Women?

Author Affiliations
  • 1Department of Medicine, University of California, San Diego, School of Medicine, La Jolla
  • 2Department of Medicine, Brigham and Women’s Hospital, Harvard Medical School, Boston, Massachusetts
JAMA Intern Med. 2017;177(12):1719-1720. doi:10.1001/jamainternmed.2017.5141

By 2020, at least 50 million women in the United States will be postmenopausal, and the vast majority will have vasomotor symptoms (hot flashes) during the menopause transition and years beyond. The use of compounded bioidentical hormone therapy (cBHT) (Table), obtained from compounding pharmacies, is increasing among perimenopausal and postmenopausal women.1-5 Virtually every medical society that provides guidance to clinicians treating women who are perimenopausal and postmenopausal recommends against prescribing cBHT. Instead, guidelines endorse judicious use of menopausal hormone therapy products regulated and approved by the US Food and Drug Administration (FDA).1,2 This preference reflects concerns about cBHT products including nonuniform dosing, inconsistencies in manufacturing standards and state regulatory oversight, potential for product contamination and/or impurities, lack of patient package inserts regarding anticipated risks, and lack of scientific evidence for efficacy or safety. Moreover, a variety of FDA-approved “bioidentical” menopausal hormone therapy formulations are available (Table). Use of these formulations ensures consistent manufacturing standards and federal regulatory oversight, inclusion of patient package inserts and labeling regarding risks, and scientific evidence supporting claims of efficacy and safety.1,2

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