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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 Search for other works by this author on: Oxford Academic Ashkan P Langroudi, MD Male Reproductive Medicine and Surgery, Department of Urology, School of Medicine, Stanford University , Stanford, CA 94305, United States Search for other works by this author on: Oxford Academic 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 Search for other works by this author on: Oxford Academic
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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