Objective: The reports submitted to the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) from 1997 to 2011 were reviewed to assess serious adverse events induced by the administration of antipsychotics to children.Methods: Following pre-processing of FAERS data by elimination of duplicated records as well as adjustments to standardize drug names, reports involving haloperidol, olanzapine, quetiapine, clozapine, ziprasidone, risperidone, and aripiprazole were analyzed in children (age 0-12). Signals in the data that signified a drug-associated adverse event were detected via quantitative data mining algorithms. The algorithms applied to this study include the empirical Bayes geometric mean, the reporting odds ratio, the proportional reporting ratio, and the information component of a Bayesian confidence propagation neural network. Neuroleptic malignant syndrome (NMS), QT prolongation, leukopenia, and suicide attempt were focused on as serious adverse events.Results: In regard to NMS, the signal scores for haloperidol and aripiprazole were greater than for other antipsychotics. Significant signals of the QT prolongation adverse event were detected only for ziprasidone and risperidone. With respect to leukopenia, the association with clozapine was noteworthy. In the case of suicide attempt, signals for haloperidol, olanzapine, quetiapine, risperidone, and aripiprazole were detected.Conclusions: It was suggested that there is a level of diversity in the strength of the association between various first- and second-generation antipsychotics with associated serious adverse events, which possibly lead to fatal outcomes. We recommend that research be continued in order to gather a large variety and quantity of related information, and that both available and newly reported data be placed in the context of multiple medical viewpoints in order to lead to improved levels of care.
A misch metal, an alloy of light rare earth elements, was analyzed by a new coupled analytical method, ITP-PIXE(isotachophoresis—Particle Induced X-ray Emission) : The sample solution containing ca.1 mg misch metal was separated and fractionated by the use of a preparative isotacho-phoretic analyzer. The dropwise fractions containing nanomole rare earth elements were analyzed off-line by PIXE. The matrix effect in X-ray measurement was reduced by the isotachophoretic removing of the dominant lanthanoids and preconcentration of the trace elements of interest. Consequently the minor elements, Sm, Gd, Tb, Dy, Ho, Er, Yb and Y could be determined accurately. The most trace element found was Yb (4ppm, 4ng in 1mg sample). The good accuracy of ITP-PIXE method was also demonstrated for several model samples of lanthanoids, where La was the dominant element and the thirteen lanthanoids were the minor elements. The ratio was varied from 500:1 to 50000:1. Even in the case of 50000:1, ca. 10% accuracy was achieved for each minor element except for Sm(23%), Gd(17%) and Yb(18%). The analytical results by ITP-PIXE were compared with those by means of ICP-AES(Inductively Coupled Plasma—Atomic Emission Spectrometry).
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