Pharmaceuticals and Medical Devices Agency (PMDA), 3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo, 100-0013, Japan.
, Kurume, Japan.
Drug Saf. 2020 Nov;43(11):1121-1131. doi: 10.1007/s40264-020-00968-7.
Increased post-marketing reports of interstitial lung disease in Japan have been recognized. An understanding of its regional groundings can be important for the global pharmacovigilance community.
The objective of this study was to explore the correlation between high rates of interstitial lung disease reporting and regulatory actions in Japan.
Post-marketing interstitial lung disease-related label changes and interstitial lung disease reports were classified by the anatomical therapeutic chemical classification groups of the suspected drugs. Regulatory actions for the top interstitial lung disease-reporting drugs were compared. The interstitial lung disease reporting patterns of protein kinase inhibitors were compared to those of methotrexate.
Interstitial lung disease-related label changes predominantly occurred for drugs in the anatomical therapeutic chemical classification groups L, J, C, and herbal medicines. Interstitial lung disease was reported most frequently for L group, especially for the protein kinase inhibitors. The regulatory actions for those drugs with the highest number of interstitial lung disease reports (methotrexate, protease kinase inhibitors, gemcitabine, docetaxel) plus monoclonal antibodies were analyzed. The ratio of interstitial lung disease reports to all reports over time was initially high in the re-examination period, while it was constantly low after the period expired. The increase in interstitial lung disease reporting was observed for the drugs for which interstitial lung disease was designated as a priority item in the use-results survey. Methotrexate had more interstitial lung disease reports with multiple suspected drugs and fewer reports with high completeness than the protease kinase inhibitors.
The high rates of interstitial lung disease reporting derived from mainly the anatomical therapeutic chemical classification group L drugs. Interstitial lung disease is the targeted adverse drug reaction in the use-results survey mandated in the re-examination of those drugs. This system provides at least one explanation for the high reporting of interstitial lung disease in Japan.
在日本，人们已经认识到上市后报告的间质性肺病病例有所增加。了解其区域性基础对于全球药物警戒界可能很重要。
本研究的目的是探讨日本间质性肺病高报告率与监管行动之间的相关性。
根据可疑药物的解剖治疗化学分类组，对与间质性肺病相关的标签变化和间质性肺病报告进行分类。比较了报告间质性肺病的前几种药物的监管措施。比较了蛋白激酶抑制剂与甲氨蝶呤的间质性肺病报告模式。
间质性肺病相关的标签变化主要发生在解剖治疗化学分类组 L、J、C 和草药的药物中。L 组药物报告的间质性肺病最多，尤其是蛋白激酶抑制剂。对间质性肺病报告数量最多的药物（甲氨蝶呤、蛋白激酶抑制剂、吉西他滨、多西他赛）加上单克隆抗体进行了监管行动分析。间质性肺病报告与所有报告的比值在重新审查期间最初较高，而在审查期结束后一直较低。在使用结果调查中，将间质性肺病指定为优先项目的药物报告间质性肺病的情况有所增加。与蛋白激酶抑制剂相比，甲氨蝶呤的间质性肺病报告具有更多的疑似药物和更少的高完整性报告。
间质性肺病高报告率主要来自于解剖治疗化学分类组 L 的药物。间质性肺病是这些药物重新审查中使用结果调查中规定的靶向不良药物反应。该系统至少为日本间质性肺病高报告提供了一个解释。
