LAUSR

Lurasidone is a second-generation antipsychotic used in the treatment of schizophrenia and bipolar disorder [1]. An analysis to identify adverse drug events (ADEs) associated with lurasidone in children is lacking. The aim of this investigation was to identify the 20 most common ADEs associated with lurasidone in paediatric patients. Elsevier’s PharmaPendium database was used to analyse unique reports of lurasidone as the primary suspect drug in paediatric patients (aged under 18 years), submitted for the period 2016-01-01 to 2018-12-31 [2]. PharmaPendium currently contains 13,487,589 US Food and Drug Administration Adverse Event Reporting System reports. These post-marketing reports contain relevant anonymised information relating to the ADE(s), provided by patients and/ or healthcare professionals. We verified the preferred terms from the Medical Dictionary for Regulatory Activities, version 22.1, and retrieved reports as per the preferred term. Multiple methods were used to identify disproportionate signals using ‘R’ statistical software, version 3.6.1 (Table 1). These included the reporting odds ratio (ROR), proportional reporting ratio (PRR) alongside the 2 and the information component (IC). These were calculated in comparison with paediatric patients within the same age and study date range. Ninety-five percent confidence intervals (CIs) were determined for the ROR, PRR and IC. A signal was determined when the ROR 95% CI lower threshold exceeded 1, the PRR was over 2 with a corresponding 2 of over 4 and an IC 95% CI lower value of over 0 [3]. After extraction and de-duplication of reports, there were 294 ADEs within 120 unique reports for paediatric patients between the date range of 2016-01-01 and 2018-12-31. The