Adverse event reports in patients taking psychiatric medication during pregnancy from spontaneous reports in Japan and the United States: an approach using latent class analysis

Abstract

Background: 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). Methods: 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. Results: 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).

Analysis of Clinical Factors in Olaparib-related Anemia Using Adverse Drug Event Reporting Databases

“…Data were extracted from FAERS and JADER between the rst quarter of 2018 and the fourth quarter of 2021 in this study. FAERS includes 14,000,000 cases of adverse events reported after April 2004 worldwide [5]. JADER includes 440,000 cases of adverse events that occurred speci cally in Japan after April 2004 [5].…”

“…FAERS includes 14,000,000 cases of adverse events reported after April 2004 worldwide [5]. JADER includes 440,000 cases of adverse events that occurred speci cally in Japan after April 2004 [5]. FAERS database consists of seven data tables: patient demographic and administrative information, drug and biologic information, adverse events, patient outcomes, report sources, start end dates of drug therapy, and indications for use/diagnosis.…”

Association between voriconazole-induced visual hallucination and dopamine in an analysis of the food and drug administration (FDA) adverse event reporting system database

“…The FAERS database contains over 1.4 million cases of spontaneous adverse events submitted by pharmaceutical companies, clinicians, pharmacists, and patients. It contains the following types of data: patient demographics, administrative information, drug names, adverse events, patient outcomes, report sources, therapy dates, and indications for use 17 . Informed consent was not required since our study was based on a public database.…”