The Clinical Utility of Compounded Bioidentical Hormone Therapy: A Review of Safety, Effectiveness, and Use (2020)
Chapter: Appendix H: Boxed Warnings on U.S. Food and Drug AdministrationApproved Estrogen and Testosterone Products
Appendix H
Boxed Warnings on U.S. Food and Drug Administration–Approved Estrogen and Testosterone Products
All U.S. Food and Drug Administration (FDA)-approved estrogen-containing products (Stefanick, 2005) and topical testosterone products (FDA, 2015) must contain a boxed warning that provides the prescriber and patient with safety warnings for the most serious adverse events associated with the use of these products. See Figures H-1 and H-2 for the boxed warning for FDA-approved estrogen-containing and topical testosterone products, respectively.
REFERENCES
FDA (U.S. Food and Drug Administration). 2015. Testosterone information. https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/testosteroneinformation (accessed December 20, 2019).
NLM (National Library of Medicine). 2020a. Alora drug label information, warning: Endometrial cancer, cardiovascular disorders, probable dementia and breast cancer. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a0d4f0b8-5dcc-4ffe-9590-0203e869622f&audience=consumer (accessed May 14, 2020).
NLM. 2020b. Androgel 1% drug label information, warning: Secondary exposure to testosterone. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c506aaa3-04f8-4eb1-8dc4-e964cdd08e7f&audience=consumer (accessed May 14, 2020).
Stefanick, M. L. 2005. Estrogens and progestins: Background and history, trends in use, and guidelines and regimens approved by the U.S. Food and Drug Administration. American Journal of Medicine 118(Suppl 12B):64–73.
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