Clinical and Translational Research Center, Niigata University Medical and Dental Hospital, Niigata, Japan.
Office of Pharmacovigilance, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.
Clin Transl Sci. 2024 Apr;17(4):e13803. doi: 10.1111/cts.13803.
Drug safety communications (DSCs) are essential tools for communicating important postmarket serious drug safety information to healthcare professionals and patients. Previous studies characterized DSCs issued by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA); however, knowledge about the activities of the Pharmaceuticals and Medical Devices Agency (PMDA)/the Ministry of Health, Labor and Welfare (MHLW) is limited. This study characterized DSCs by the PMDA/MHLW in comparison with previously reported DSCs by the FDA and the EMA. We retrospectively analyzed 37 DSCs of 41 adverse drug reactions (ADRs) for 33 drugs in Japan from 1997 to 2022. Most DSCs were related to non-oncology drugs (30/37, 81.1%), and the median (interquartile range) time from approval to DSC issuance was 19 (10-51) months. Notably, the regulatory review reports and the latest labels before DSC issuance did not describe 16/28 (57.1%) and 12/37 (32.4%) of the ADRs related to DSCs, respectively. Most DSCs resulted in label revisions (36/37, 97.3%) and seven drugs were eventually withdrawn. Some DSC characteristics are similar among the PMDA/MHLW, the FDA, and the EMA; however, the number, contents, and range of new safety issues addressed by DSCs differ among the three jurisdictions. Our study emphasized the importance of continuous efforts to gather postmarket drug safety information because substantial ADRs that led to DSCs were recognized after approval and were associated with critical label revisions and withdrawals. Future studies are required to address global challenges for regulatory harmonization of safety-related regulatory actions.
药品安全通讯（DSC）是向医疗保健专业人员和患者传达重要的上市后严重药物安全信息的重要工具。以前的研究已经对美国食品和药物管理局（FDA）和欧洲药品管理局（EMA）发布的 DSC 进行了描述；然而，对日本药品和医疗器械管理局（PMDA）/厚生劳动省（MHLW）的活动的了解是有限的。本研究通过 PMDA/MHLW 与之前由 FDA 和 EMA 报告的 DSC 进行了比较。我们回顾性分析了 1997 年至 2022 年期间日本的 33 种药物的 41 种不良反应（ADR）共 37 份 DSC。大多数 DSC 与非肿瘤药物有关（30/37，81.1%），从批准到发布 DSC 的中位（四分位距）时间为 19（10-51）个月。值得注意的是，监管审查报告和 DSC 发布前的最新标签没有描述与 DSC 相关的 28 种 ADR 中的 16 种（57.1%）和 37 种 DSC 中的 12 种（32.4%）。大多数 DSC 导致标签修订（36/37，97.3%），最终有 7 种药物被撤市。PMDA/MHLW、FDA 和 EMA 之间存在一些 DSC 特征相似，但三者之间发布的新安全性问题的数量、内容和范围不同。本研究强调了不断努力收集上市后药物安全信息的重要性，因为在批准后发现了大量导致 DSC 的不良反应，这些不良反应与关键的标签修订和撤市有关。需要进一步研究以应对监管协调方面的全球挑战。
