title: Hypersensitivity reactions to anticancer agents: data mining of the public version of the FDA adverse event reporting system, AERS.
abstract: BACKGROUND
  Previously, adverse event reports (AERs) submitted to the US Food and Drug Administration (FDA) database were reviewed to confirm platinum agent-associated hypersensitivity reactions. The present study was performed to confirm whether the database could suggest the hypersensitivity reactions caused by anticancer agents, paclitaxel, docetaxel, procarbazine, asparaginase, teniposide, and etoposide.
  
  
  METHODS
  After a revision of arbitrary drug names and the deletion of duplicated submissions, AERs involving candidate agents were analyzed. The National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 was applied to evaluate the susceptibility to hypersensitivity reactions, and standardized official pharmacovigilance tools were used for 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, the signals were detected for paclitaxel-associated mild, severe, and lethal hypersensitivity reactions, and docetaxel-associated lethal reactions. However, the total number of adverse events occurring with procarbazine, asparaginase, teniposide, or etoposide was not large enough to detect signals.
  
  
  CONCLUSIONS
  The FDA's adverse event reporting system, AERS, and the data mining methods used herein are useful for confirming drug-associated adverse events, but the number of co-occurrences is an important factor in signal detection.
authors.affiliation: Graduate School of Pharmaceutical Sciences, Kyoto University, Kyoto 606-8501, Japan.
authors.forename: Kaori
authors.initials: K
authors.lastname: Kadoyama
authors.forename: Akiko
authors.initials: A
authors.lastname: Kuwahara
authors.forename: Motohiro
authors.initials: M
authors.lastname: Yamamori
authors.forename: J B
authors.initials: JB
authors.lastname: Brown
authors.forename: Toshiyuki
authors.initials: T
authors.lastname: Sakaeda
authors.forename: Yasushi
authors.initials: Y
authors.lastname: Okuno
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems; D000970:Antineoplastic Agents / Q000009:adverse effects*; D001215:Asparaginase / Q000009:adverse effects; D001499:Bayes Theorem; D057225:Data Mining; D000077143:Docetaxel; D004342:Drug Hypersensitivity / Q000188:drug therapy / Q000209:etiology*; D005047:Etoposide / Q000009:adverse effects; D006801:Humans; D017239:Paclitaxel / Q000009:adverse effects; D060735:Pharmacovigilance; D011344:Procarbazine / Q000009:adverse effects; D011379:Prognosis; D043823:Taxoids / Q000009:adverse effects; D013713:Teniposide / Q000009:adverse effects; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D000970:Antineoplastic Agents; D043823:Taxoids; D000077143:Docetaxel; D011344:Procarbazine; D005047:Etoposide; D013713:Teniposide; D001215:Asparaginase; D017239:Paclitaxel