Abstract
BackgroundPreviously, 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.MethodsAfter 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.ResultsBased 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.ConclusionsThe 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.
Highlights
Adverse event reports (AERs) submitted to the US Food and Drug Administration (FDA) database were reviewed to confirm platinum agent-associated hypersensitivity reactions
More than a million case reports on adverse events (AERs) submitted to the US Food and Drug Administration (FDA) database were used, and a statistically significant association with an adverse event was detected as a signal, by applying standardized official pharmacovigilance methods [8,9,10,11,12,13,14]
adverse event reports (AERs) submitted to the FDA were analyzed to detect signals for Hypersensitivity reactions (HSRs) caused by paclitaxel, docetaxel, procarbazine, asparaginase, teniposide, and etoposide, in order to more clarify the critical factors to reproduce the clinical observations on HSRs
Summary
Adverse event reports (AERs) submitted to the US Food and Drug Administration (FDA) database were reviewed to confirm platinum agent-associated hypersensitivity reactions. More than a million case reports on adverse events (AERs) submitted to the US Food and Drug Administration (FDA) database were used, and a statistically significant association with an adverse event was detected as a signal, by applying standardized official pharmacovigilance methods [8,9,10,11,12,13,14]. AERs submitted to the FDA were analyzed to detect signals for HSRs caused by paclitaxel, docetaxel, procarbazine, asparaginase, teniposide, and etoposide, in order to more clarify the critical factors to reproduce the clinical observations on HSRs. agents thought to be associated with HSRs were analyzed, including doxorubicin, 6-mercaptopurine, 5-fluorouracil, cyclophosphamide and cytarabine
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