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.
FIGURE H-1
Boxed warning included with FDA-approved estrogen-containing products. SOURCE: NLM, 2020a.
FIGURE H-2
Boxed warning included with FDA-approved topical testosterone products. SOURCE: NLM, 2020b.
REFERENCES
- FDA (U.S. Food and Drug Administration). Testosterone information. 2015. [December 20, 2019]. https://www
.fda.gov/drugs /postmarket-drug-safety-information-patients-and-providers /testosteroneinformation. - NLM (National Library of Medicine). Alora drug label information, warning: Endometrial cancer, cardiovascular disorders, probable dementia and breast cancer. 2020a. [May 14, 2020]. https://dailymed
.nlm .nih.gov/dailymed/drugInfo .cfm?setid=a0d4f0b8-5dcc-4ffe-9590-0203e869622f&audience=consumer. - NLM. Androgel 1% drug label information, warning: Secondary exposure to testosterone. 2020b. [May 14, 2020]. https://dailymed
.nlm .nih.gov/dailymed/drugInfo .cfm?setid=c506aaa3-04f8-4eb1-8dc4-e964cdd08e7f&audience=consumer. - Stefanick ML. 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. 2005;118(Suppl 12B):64–73. [PubMed: 16414329]
Publication Details
Copyright
Publisher
National Academies Press (US), Washington (DC)
NLM Citation
National Academies of Sciences, Engineering, and Medicine; Health and Medicine Division; Board on Health Sciences Policy; Committee on the Clinical Utility of Treating Patients with Compounded Bioidentical Hormone Replacement Therapy; Jackson LM, Parker RM, Mattison DR, editors. The Clinical Utility of Compounded Bioidentical Hormone Therapy: A Review of Safety, Effectiveness, and Use. Washington (DC): National Academies Press (US); 2020 Jul 1. Appendix H, Boxed Warnings on U.S. Food and Drug Administration–Approved Estrogen and Testosterone Products.
