Drug-induced Neuropsychiatric Adverse Events Using Post-Marketing Surveillance

BACKGROUND: Several studies reported that abnormal behavior was noted in pediatric pa- tients receiving several drugs, including neuraminidase inhibitors (NIs). However, the information on drugs associated with abnormal behavior in a real-world setting remains limited. The purpose of this study was to clarify the drugs associated with abnormal behavior using a spontaneous reporting sys- tem database. METHODS: We performed a retrospective pharmacovigilance disproportionality analysis using the Jap- anese Adverse Drug Event Report database. Adverse event reports submitted to the Pharmaceuticals and Medical Devices Agency were analyzed, and the reporting odds ratio at 95% confidence interval were calculated. RESULTS: A total of 1,144 reports of abnormal behavior were identified. The signals were detected through the association of 4 neuraminidase inhibitors (oseltamivir, zanamivir, laninamivir, and peram- ivir) with the abnormal behaviour. These signals were stronger for oseltamivir than other neuramini- dase inhibitors. The signals were also detected for acetaminophen and montelukast. CONCLUSION: Our results should be able to raise physicians’ awareness of drugs associated with ab- normal behavior, but further investigation of these medications is warranted.