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Int J Med Sci 2011; 8(4):332-338. doi:10.7150/ijms.8.332 This issue Cite

Research Paper

Platinum Agent-Induced Hypersensitivity Reactions: Data Mining of the Public Version of the FDA Adverse Event Reporting System, AERS

Toshiyuki Sakaeda^1✉, Kaori Kadoyama¹, Hiroaki Yabuuchi^2,3, Satoshi Niijima², Kyoko Seki⁴, Yukinari Shiraishi⁴, Yasushi Okuno^{2, 3✉}

1. Center for Development of Integrative Education in Pharmacy and Pharmaceutical Sciences, Graduate School of Pharmaceutical Sciences, Kyoto University, Kyoto 606-8501, Japan
2. Department of Systems Biosciences for Drug Discovery, Graduate School of Pharmaceutical Sciences, Kyoto University, Kyoto 606-8501, Japan
3. Kyoto Constella Technologies Co., Ltd., Kyoto 604-8156, Japan
4. Department of Pharmacy, Japan Labour Health and Welfare Organization, Kobe Rosai Hospital, Kobe 651-0053, Japan

✉ Corresponding author: Toshiyuki Sakaeda, Ph.D., Center for Development of Integrative Education in Pharmacy and Pharmaceutical Sciences, Graduate School of Pharmaceutical Sciences, Kyoto University, Kyoto 606-8501, Japan, Tel: +81-75-753-9560, Fax: +81-75-753-4502, e-mail: sakaedatkyoto-u.ac.jp; Yasushi Okuno, Ph.D., Department of Systems Biosciences for Drug Discovery, Graduate School of Pharmaceutical Sciences, Kyoto University, Kyoto 606-8501, Japan, Tel&Fax: +81-75-753-4559, e-mail: okunokyoto-u.ac.jp More

Abstract

Objective: Adverse event reports (AERs) submitted to the US Food and Drug Administration (FDA) were reviewed to confirm the platinum agent-associated mild, severe, and lethal hypersensitivity reactions.

Methods: Authorized pharmacovigilance tools were used for quantitative signal detection, including the proportional reporting ratio, the reporting odds ratio, the information component given by a Bayesian confidence propagation neural network, and the empirical Bayes geometric mean. Excess2, given by the multi-item gamma Poisson Shrinker algorithm, was used to evaluate the effects of dexamethasone and diphenhydramine on oxaliplatin-induced hypersensitivity reactions.

Results: Based on 1,644,220 AERs from 2004 to 2009, carboplatin and oxaliplatin proved to cause mild, severe, and lethal hypersensitivity reactions, whereas cisplatin did not. Dexamethasone affected oxaliplatin-induced mild hypersensitivity reactions, but had lesser effects on severe and lethal reactions. The effects of diphenhydramine were not confirmed.

Conclusion: The FDA's adverse event reporting system, AERS, with optimized data mining tools is useful to authorize potential associations between platinum agents and hypersensitivity reactions.

Keywords: adverse event, AERS, platinum agent, hypersensitivity

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