Int J Med Sci 2011; 8(6):487-491. doi:10.7150/ijms.8.487

Research Paper

Adverse Event Profiles of Platinum Agents: Data Mining of the Public Version of the FDA Adverse Event Reporting System, AERS, and Reproducibility of Clinical Observations

Toshiyuki Sakaeda1✉, Kaori Kadoyama1, Yasushi Okuno2,3✉

1. Center for 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

Abstract

Objective: Adverse event reports (AERs) submitted to the US Food and Drug Administration (FDA) were reviewed to confirm platinum agent-associated adverse events, and to clarify the rank-order of these drugs in terms of susceptibility.

Methods: After a revision of arbitrary drug names and the deletion of duplicated submissions, AERs involving cisplatin (CDDP), carboplatin (CBDCA), or oxaliplatin (L-OHP) were analyzed. Authorized pharmacovigilance tools were used for the quantitative detection of signals, i.e., drug-associated adverse events, 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.

Results: Based on 1,644,220 AERs from 2004 to 2009, CDDP, CBDCA, and L-OHP all proved to cause nausea, vomiting, acute renal failure, neutropenia, thrombocytopenia, and peripheral sensory neuropathy. Higher susceptibility to nausea was found for CDDP than CBDCA and L-OHP. Acute renal failure was also more predominant for CDDP, and CBDCA did not increase the blood level of creatinine. A stronger association with thrombocytopenia was suggested for CBDCA. Susceptibility to peripheral sensory neuropathy was greatest for L-OHP, but less extensive for CDDP and CBDCA.

Conclusion: The results obtained herein were consistent with clinical observations, suggesting the usefulness of the FDA's adverse event reporting system, AERS, and the data mining method used herein.

Keywords: adverse event, AERS, platinum agent, pharmacovigilance

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How to cite this article:
Sakaeda T, Kadoyama K, Okuno Y. Adverse Event Profiles of Platinum Agents: Data Mining of the Public Version of the FDA Adverse Event Reporting System, AERS, and Reproducibility of Clinical Observations. Int J Med Sci 2011; 8(6):487-491. doi:10.7150/ijms.8.487. Available from http://www.medsci.org/v08p0487.htm