著者

豕瀬 諒 細見 光一 朴 ピナウル 藤本 麻依 髙田 充隆

出版者

一般社団法人日本医療薬学会

雑誌

医療薬学 (ISSN:1346342X)

巻号頁・発行日

vol.40, no.10, pp.586-594, 2014-10-10 (Released:2015-10-10)

参考文献数

36

被引用文献数

4 3

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To examine the association between biologics for rheumatoid arthritis and serious infections (hepatitis B, hepatitis C, tuberculosis, pneumonia and sepsis), we analyzed the US Food and Drug Administration Adverse Event Reporting System (FAERS) and the Japanese Adverse Drug Event Report database (JADER) of Pharmaceuticals and Medical Devices Agency (PMDA). The reporting odds ratio was calculated and used to detect spontaneous report signals, with detection defined as a lower limit >1 in a 95% confidence interval. In addition, time to onset and age at onset of tuberculosis were investigated. Drug-reaction pairs were identified in both FAERS (n = 29,017,485) and JADER (n = 2,079,653). In both databases, significant associations were observed between biologics and infections (hepatitis B, tuberculosis, pneumonia and sepsis). JADER data revealed a significant association of etanercept with hepatitis C. In FAERS, the majority of tuberculosis events, associated with all drugs, were observed within 1 month of administration, whereas most tuberculosis infections associated with biologics were observed during the 5 months following administration. In JADER, most cases of tuberculosis associated with all drugs and with biologics, respectively, were observed during the 2 months after administration. In conclusion, hepatitis C associated with etanercept treatment should be closely monitored in clinical practice. In addition, tuberculosis associated with biologics should be carefully monitored for 5 months following drug administration. Further studies are needed to confirm these findings.

著者

細見 光一 新居 万莉 藤本 麻依 高田 充隆

出版者

一般社団法人日本医薬品情報学会

雑誌

医薬品情報学 (ISSN:13451464)

巻号頁・発行日

vol.17, no.1, pp.15-20, 2015 (Released:2015-06-28)

参考文献数

47

被引用文献数

1

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Objective: Signal detection by analyzing adverse event spontaneous report databases is used to monitor drug safety.  One of the major spontaneous report databases is the FDA Adverse Event Reporting System (FAERS).  Recently, the Japanese Adverse Drug Event Report database (JADER) was released.  To compare FAERS and JADER, we calculated the signals of adverse events by new quinolones (NQs).Methods: We extracted reports of adverse events by NQs from FAERS and JADER, and analyzed them using the ROR data mining algorithm.  Thirteen kinds of NQs were extracted, and the terms of adverse events extracted were defined by MedDRA.Results: There were 35,990,645 reports in FAERS and 1,643,404 reports in JADER.  Significant RORs were found for hypersensitivity (FAERS: 1.78, JADER: 1.47), arrhythmia (1.07, 0.68), hypoglycemia (1.80, 2.03), hyperglycemia (0.72, 0.78), rhabdomyolysis (1.01, 0.78), tendon disorders (15.18, 6.59), psychiatric symptoms (1.12, 0.45) and convulsion (0.99, 1.31).  We identified 4 types of adverse events by comparing FAERS and JADER: 1) Signal detection in both, 2) No signal detection in either, 3) Signal detection only in FAERS, 4) Signal detection only in JADER.Conclusion: Analyzing spontaneous report databases has several limitations, but is still a valuable tool for identifying potential associations between drugs and adverse events.  Spontaneous report databases may also be useful for detecting differences in adverse events between different races, countries and regions.

著者

細見 光一 朴 ピナウル 豕瀬 諒 藤本 麻依 高田 充隆

出版者

Japanese Society of Drug Informatics

雑誌

医薬品情報学 (ISSN:13451464)

巻号頁・発行日

vol.17, no.3, pp.125-132, 2015 (Released:2015-12-18)

参考文献数

39

被引用文献数

2

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Objective: To examine the association between atypical and typical antipsychotics and extrapyramidal symptoms (EPS), we analyzed the US Food and Drug Administration Adverse Event Reporting System (FAERS) and the Japanese Adverse Drug Event Report database (JADER) from the Pharmaceuticals and Medical Devices Agency (PMDA).Methods: A reporting odds ratio was calculated and used to detect spontaneous report signals, with detection defined as a lower limit >1 in a 95% confidence interval.  In addition, time to onset and age at onset of EPS were investigated.Results: Drug-reaction pairs were identified in both FAERS (n=29,017,485) and JADER (n=2,079,653).  In analyses of both databases, significant associations were found between atypical and typical antipsychotics and EPS.  Atypical antipsychotics cause EPS with a longer duration of therapy compared to typical ones.  EPS in patients treated with atypical antipsychotics was observed at a broad range of ages compared to the patients treated with typical ones.Conclusion: Atypical antipsychotics, like typical ones, may increase the risk of EPS.  Because of the longer latency of onset, it may be difficult to find EPS associated with atypical antipsychotics.  Therefore, the severe symptom may be developed in patients treated with atypical antipsychotics.  The attention should be paid to the EPS in patients of all ages treated with atypical antipsychotics.

著者

藤本 麻依 高本 真志 細見 光一 高田 充隆

出版者

一般社団法人日本医薬品情報学会

雑誌

医薬品情報学 (ISSN:13451464)

巻号頁・発行日

vol.16, no.2, pp.53-62, 2014 (Released:2014-09-06)

参考文献数

31

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Objective: To examine the association between statin use and the risk of sleep disturbances, data mining was performed on a claims database. Methods: Symmetry analysis was carried out to identify the risk of sleep disturbances after statin use during the period from January 2005 to December 2011.  Statin use in combination with hypnotic drugs was examined by prescription sequence symmetry analysis.  In this study, hypnotic drugs that are commonly prescribed for the treatment of insomnia were used as markers of sleep disturbances produced by statins. Likewise, event sequence symmetry analysis was undertaken to evaluate the association between statin use and the diagnosis of sleep disturbances.Results: Significant associations of statin use with short-acting hypnotic drugs were found, with an adjusted SR (sequence ratio) of 1.23 (95%CI: 1.04-1.45) at an interval of 12 months.  Otherwise, significant associations between individual statin use and hypnotic drug use were not found.  Significant associations between use of statins and the diagnosis of sleep disturbances were not also found in this study.Conclusions: Analysis of the claim database demonstrated that statin therapy might be associated with an emergence of sleep disturbances.  Therefore, individuals prescribed statins should be considered as having an increased risk of sleep disturbances.