What is the validity of the Federal Adverse Event Reporting System in contemporary clinical research? (2025)

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Volume 21 Issue 9 September 2024
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Albert Ha, MD

Male Reproductive Medicine and Surgery, Department of Urology, School of Medicine,

Stanford University

, Stanford, CA 94305,

United States

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Ashkan P Langroudi, MD

Male Reproductive Medicine and Surgery, Department of Urology, School of Medicine,

Stanford University

, Stanford, CA 94305,

United States

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Michael L Eisenberg, MD

Male Reproductive Medicine and Surgery, Department of Urology, School of Medicine,

Stanford University

, Stanford, CA 94305,

United States

Corresponding author: Male Reproductive Medicine and Surgery, Department of Urology, School of Medicine, Stanford University, Stanford, CA 94305, United States. Tel: (650) 725-5546; Fax:

(650) 723-4200

; Email: eisenberg@stanford.edu

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The Journal of Sexual Medicine, Volume 21, Issue 9, September 2024, Pages 744–745, https://doi.org/10.1093/jsxmed/qdae072

Published:

04 September 2024

Article history

Received:

17 April 2024

Revision received:

05 June 2024

Accepted:

17 June 2024

Published:

04 September 2024

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    Albert Ha, Ashkan P Langroudi, Michael L Eisenberg, What is the validity of the Federal Adverse Event Reporting System in contemporary clinical research?, The Journal of Sexual Medicine, Volume 21, Issue 9, September 2024, Pages 744–745, https://doi.org/10.1093/jsxmed/qdae072

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The Federal Adverse Event Reporting System (FAERS) is a publicly available database sponsored by the US Food and Drug Administration (FDA) that is designed for postmarketing drug safety surveillance through reports of adverse events (AEs), medication errors, and other quality issues for drugs and therapeutic agents released to the market. Even with its limitations, the FAERS repository has played a critical role in the identification of AEs among various medications. In this essay, we examine the development of FAERS, evaluate its strengths and weaknesses within contemporary clinical research, and identify areas for future improvement.

Evolution of pharmacovigilance

The evolution of pharmacovigilance has been driven by key events and reflects the importance of drug safety and monitoring of drug-related AEs. The origins of FAERS date back to 1938, following a tragic event in which the contamination of a sulfanilamide elixir with diethyl glycol led to over 100 deaths.1 This incident catalyzed the passage of the Federal Food, Drug, and Cosmetic Act of 1938, which empowered the FDA to begin regulating the sale of food, drugs, medical devices, and cosmetics to reduce risks of misbranding and product adulteration.1

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