Vol.59 No.6 November 2011

Data mining of the public version of the FDA Adverse Event Reporting System, AERS: Colistin-associated adverse events

Toshiyuki Sakaeda¹⁾, Kaori Kadoyama¹⁾, Akiko Tamon³⁾ and Yasushi Okuno^2,3)

¹⁾Center for Integrative Education in Pharmacy and Pharmaceutical Sciences, Graduate School of Pharmaceutical Sciences, Kyoto University, 46-29 Yoshidashimoadachi-cho, Sakyo-ku, Kyoto, Japan
²⁾Department of Systems Biosciences for Drug Discovery, Graduate School of Pharmaceutical Sciences, Kyoto University, 46-29 Yoshidashimoadachi-cho, Sakyo-ku, Kyoto, Japan
³⁾Kyoto Constella Technologies Co., Ltd.

Abstract

Adverse event reports(AERs) submitted to the US Food and Drug Administration(FDA) were reviewed to analyze the colistin-associated adverse events. Authorized pharmacovigilance algorithms 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. Based on 1,644,220 AERs from 2004 to 2009, it was suggested that a total of 238 adverse events was possibly caused by colistin.

Key word

adverse event, Adverse Event Reporting System (AERS), colistin, data mining

Received

February 2, 2011

Accepted

August 2, 2011

Jpn. J. Chemother. 59 (6): 610-613, 2011