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

豕瀬 諒 髙谷 瑞穂 村木 優一

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.22, no.3, pp.135-140, 2020-11-30 (Released:2020-12-15)

参考文献数

13

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Objective: In Japan, healthcare professionals are required to report the adverse drug events that occur with the use of medicines to the Minister of Health, Labor, and Welfare. The reported information is collected in the Japanese Adverse Drug Event Report database (JADER) and is freely available. There are no reports that evaluated the adverse events (AEs) in JADER based on the need for a physician’s diagnosis. This study classified AEs by pharmacists or physicians in JADER based on the need for a physician’s diagnosis and evaluated the differences in their contents.Methods: AEs reported by pharmacists, physicians, pharmacists and physicians in the economic years 2004 to 2017 in JADER were collected annually, and the trends were compared. The AEs of methotrexate in 2017 were classified into two groups based on the need for a physician’s diagnosis. The necessity of a physician’s diagnosis was judged by two senior pharmacists and compared using the chi-squared test.Results: The number of AEs reported by pharmacists and physicians from 2004 to 2017 increased from 689 to 7,127 and from 20,933 to 39,382, respectively. Among the AEs of methotrexate in 2017, AEs requiring physician’s diagnosis reported by pharmacists were 337 events and physicians were 2,413 events. Whereas, AEs that did not require a physician’s diagnosis reported by pharmacists were 172 events and physicians were 321 events. Physicians had significantly more AEs requiring diagnosis than pharmacists did (p< 0.0001).Conclusion: The reports of pharmacists with JADER have fewer AEs with the diagnosis than those of physicians.

著者

平野 徹 豕瀬 諒 村木 優一

出版者

京都薬科大学

雑誌

京都薬科大学紀要 = Bulletin of Kyoto Pharmaceutical University (ISSN:24354112)

巻号頁・発行日

vol.3, no.1, pp.151-154, 2022-07-13

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.