Characteristics of pediatric adverse drug reaction reports in the Japanese Adverse Drug Event Report Database

Abstract

Background There are no reports on investigations of the characteristics of adverse drug reaction (ADR) reports for pediatric patients in the Japanese Adverse Drug Event Report database (JADER) and the utility of database for drug safety surveillance in these patients. Method We aimed to evaluate ADR reports for pediatric patients in the JADER. We used spontaneous ADR reports included in the JADER since April 1, 2004, to December 31, 2017, which was downloaded in April 2018. In a total of 504,407 ADR reports, the number of spontaneous reports was 386,400 (76.6%), in which 37,534 (7.4%) were unknown age reports. After extraction of 27,800 ADR reports for children aged < 10 and 10–19 years, we excepted for ADR reports associated with a vaccine (n = 6355) and no-suspected drug reports (n = 86). A total of 21,359 (4.2%) reports were finally included in this analysis. Results More than half of the ADR reports were for children aged < 10 years. Approximately 30% of ADR reports had multiple suspected drugs, which did not differ by age. The percentages of fatal outcomes of ADRs among patients aged < 10 and 10–19 years were 4.7 and 3.9%, respectively. The most frequently reported drug, reaction, and drug-reaction pair were oseltamivir, abnormal behavior, and oseltamivir and abnormal behavior, respectively. Conclusion We clarified the characteristics of ADR reports for Japanese children by using the JADER. ADR report databases, especially those for pediatric patients, are valuable pharmacovigilance tools in Japan and other countries. Therefore, a proper understanding of the characteristics of the ADR reports in the JADER is important. Additionally, potential signals for ADRs in pediatric patients should be monitored continuously and carefully.

Evaluation of Adverse Drug Reactions in Paediatric Patients: A Retrospective Study in Turkish Hospital

“…Adverse drug reactions (ADRs) are a leading cause of illness and mortality worldwide ( Giardina et al, 2018 ). Spontaneous reporting of ADRs is critical for effective post-marketing drug surveillance and patient safety ( Noda et al, 2020 ). ADRs are also related to more serious cases of liver injury due to drugs as presented in different databases ( Noda et al, 2020 ; Teschke and Danan, 2021 ), but many of these liver injury cases were poorly documented and used a global introspection method for causality ( Teschke and Danan, 2021 ).…”

“…Spontaneous reporting of ADRs is critical for effective post-marketing drug surveillance and patient safety ( Noda et al, 2020 ). ADRs are also related to more serious cases of liver injury due to drugs as presented in different databases ( Noda et al, 2020 ; Teschke and Danan, 2021 ), but many of these liver injury cases were poorly documented and used a global introspection method for causality ( Teschke and Danan, 2021 ). The limitations of these approaches include case selection based solely on published case numbers rather than a strong causality assessment method.…”

Adverse Drug Reaction Reports Regarding Abnormal Behavior After Oseltamivir Use in Children as Reported by Consumers or Healthcare Professionals

“…We previously reported that the most frequently reported drug used in children in the JADER database was oseltamivir. 5 A Dear Healthcare Professional letter about abnormal behavior after oseltamivir use in children aged >10 years was issued on March 20, 2007. 4 We demonstrated that administrative responses to safety information might be determinants of increasing ADR reports.…”

“…4 We demonstrated that administrative responses to safety information might be determinants of increasing ADR reports. 5 , 6 …”

Risk Assessment for Anti-Infectives-Related Acute Kidney Injury Using the Japanese Adverse Drug Event Report Database

“…Spontaneous reporting systems (SRSs), such as the US Food and Drug Administration (FDA) adverse event reporting system (FAERS) and the Japanese Adverse Drug Event Report (JADER) database, have been used in pharmacovigilance assessments [6][7][8][9]. The reporting odds ratio (ROR) has been used to derive an index for detecting drug-associated adverse events (AEs) [7,8].…”