Abstract
From April 2012, Japanese Adverse Drug Event Report database (JADER) has become downloadable for utilization in the public, under the specified acceptable use policy. Given the situation, we focused on the severe eruptions which cases are increased in the public Relief System for Sufferers from Adverse Drug Reactions, for the purpose to analyze the characteristics of typical severe eruptions and a trend or a commonality in the corresponding reported drugs, by utilizing JADER. Disproportionate reporting obtained with ROR (Reporting Odds Ratio) and distribution parameter estimations obtained with Weibull distribution fit for the onset time of drug adverse reactions, were applied for the analysis in addition to the summary of frequency. We obtained 10,171 cases of severe eruptions from JADER, after exclusion of duplicated reports. In the Drug Induced Hypersensitivity Syndrome (DIHS), which has characteristics in clinical time course and causal drugs, we confirmed that typical causal drugs such as anti-epilepsy are frequently reported in JADER. On the other hand, drugs other than typical causal drugs also showed high ROR signal values. In the estimation of Weibull distribution shape parameter fit for drug adverse reaction onset time, DIHS gave estimation apparently different from other severe eruptions. Coincide with the estimation, histogram of onset time for DIHS showed the peak at around 20 days after drug administration, which is later than other severe eruptions. We conclude that analytical approach to obtaining information from multiple aspects of JADER data should be a useful effort for the persons who are engaged in preventive action for drug adverse reactions.
