title: Platinum agent-induced hypersensitivity reactions: data mining of the public version of the FDA adverse event reporting system, AERS.
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.
  
  
  CONCLUSIONS
  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.
authors: Center for Development of Integrative Education in Pharmacy and Pharmaceutical Sciences, Graduate School of Pharmaceutical Sciences, Kyoto University, Kyoto, Japan. sakaedat@pharm.kyoto-u.ac.jp
authors: Toshiyuki
authors: T
authors: Sakaeda
authors: Kaori
authors: K
authors: Kadoyama
authors: Hiroaki
authors: H
authors: Yabuuchi
authors: Satoshi
authors: S
authors: Niijima
authors: Kyoko
authors: K
authors: Seki
authors: Yukinari
authors: Y
authors: Shiraishi
authors: Yasushi
authors: Y
authors: Okuno
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