TABLE 7-2Adverse Events Discovered During an FDA Inspection

Adverse EventNumber of Events Identified
Acne11
Amenorrhea1
Breast cancer154
Cellulitis529
Deep vein thrombosis40
Endometrial cancer21
Enlarged clitoris6
Facial hair7
Hair loss30
Heart attack37
Other complications427
Pellet extrusions2,335
Prostate cancer25
Stroke31
Voice deepening2

SOURCE: FDA, 2019a.

From: 7, The Safety and Effectiveness of Compounded Bioidentical Hormone Therapy

Cover of The Clinical Utility of Compounded Bioidentical Hormone Therapy
The Clinical Utility of Compounded Bioidentical Hormone Therapy: A Review of Safety, Effectiveness, and Use.
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.
Washington (DC): National Academies Press (US); 2020 Jul 1.
Copyright 2020 by the National Academy of Sciences. All rights reserved.

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