Little is known regarding the association between adverse events (AEs) and psychiatric medications administered to pregnant women in clinical trials during the pre-marketing period. This study analyzes reports of AE association with psychiatric medication administrated during pregnancy using post-marketing spontaneous reports of AE from the Japanese Adverse Drug Event Report (JADER) database and Food and Drug Administration Adverse Event Reporting System in the United States (FAERS-US). We summarized AE reports of psychiatric medication administrated during pregnancy by comparing data obtained from JADER and FAERS-US databases with medication patterns determined as classes via latent class analysis. The odds ratios (ORs) of AE reports categorized into system organ classes in which each class was compared with those without psychiatric medications. The proportions of AE reports under psychiatric medication in pregnancy among all AE reports were 22.0% and 16.6% in JADER and FAERS-US, respectively. The 10,389 reports of psychiatric medication during pregnancy were classified into 11 classes. The proportion of patients receiving four or more psychiatric drugs in JADER was larger than that in FAERS-US. The maximum number of reports in combinations of AE and medication pattern in JADER was 169, for ‘general disorders and administration site conditions’ from the class of four or more medications (OR = 9.1), while that in FAERS-US was 1,654, for ‘injury, poisoning, and procedural complications’ from the class of single psychiatric medication (OR = 2.8). The main AE reports and associated AE differed depending on medication patterns in pregnant women taking psychiatric medication. This study may provide a prediction of AEs that are likely to be reported with each medication pattern. Our findings of the association between AE reports and medication patterns could help improve the administration of psychiatric medications during pregnancy, though further research on additional datasets is needed to clarify these results.

中文翻译：

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来自日本和美国的自发报告中有关怀孕期间服用精神科药物的患者的不良事件报告：一种使用潜在类别分析的方法。

在上市前阶段的临床试验中，关于不良事件（AE）与向孕妇服用的精神科药物之间的关联知之甚少。这项研究使用来自日本不良药品事件报告（JADER）数据库和美国食品药品管理局不良事件报告系统（FAERS-US）的上市后自然事件自动报告，分析了妊娠期与精神药物相关的不良事件报告。我们通过比较从JADER和FAERS-US数据库获得的数据与通过潜在类别分析确定为类别的药物模式，总结了怀孕期间服用的精神药物的AE报告。AE报告的优势比（OR）分为系统器官类别，在该类别中将每个类别与未使用精神科药物的类别进行比较。在JADER和FAERS-US中，在怀孕期间使用精神药物治疗的AE报告占所有AE报告的比例分别为22.0％和16.6％。怀孕期间接受精神科药物治疗的10389份报告分为11类。在JADER中接受四种或更多种精神科药物治疗的患者比例高于在FAERS-US中。对于四种或以上药物类别的“一般性疾病和给药部位状况”，在JADER中，AE和药物类型组合的最大报告数为169（OR = 9.1），而在FAERS-US中，报告的最大数量为1,654。单一精神科药物类别的“伤害，中毒和程序并发症”（OR = 2.8）。根据服用精神科药物的孕妇的用药方式，主要不良事件报告和相关不良事件有所不同。这项研究可以预测每种药物模式可能报告的不良事件。我们对不良事件报告与用药模式之间关联的发现可能有助于改善妊娠期精神科用药的管理，尽管需要进一步研究其他数据集以阐明这些结果。