Adverse events and concurrent medications associated with parenteral nutrition use.

ABSTRACT

In this study, clinical manifestations of adverse events and frequently used medications in patients receiving parenteral nutrition (PN) in Korea were evaluated using Korea Adverse Event Reporting System (KAERS) database records between 2011 and 2015. Amino acids, fat emulsions, carbohydrates, combinations and solutions for PN were identified as causative agents. Adverse events classified as "certain", "probable" and "possible" based on the WHO-Uppsala Monitoring Centre criteria were analysed. In total, 6439 adverse events from 4260 patients were included for analysis. Mean patient age was 54.4 ± 18.1 years and the mean number of adverse events per patient was 1.5 ± 1.1. Frequent adverse events were gastrointestinal (2159 events, 33.5%), skin/appendage (1344 events, 20.9%), general (846 events, 13.1%) and central/peripheral nervous system (716 events, 11.1%) disorders. Common clinical symptoms were nausea (1248 events, 19.4%), vomiting (558, 8.7%), pruritus (456 events, 7.1%), rash (386 events, 6.0%) and dizziness (329 events, 5.1%). The frequently reported concomitant agents were tramadol (n = 475, 3.1%), fentanyl (n = 405, 2.7%), paracetamol (n = 329, 2.2%), ketorolac (n = 322, 2.1%) and metoclopramide (n = 289 cases, 1.9%). The frequent adverse events remained consistent after accounting for concurrent medications. Our findings from a nationwide reporting system database found that gastrointestinal disorders (nausea and vomiting) were the leading adverse events, requiring further studies on their prevalence, mechanisms and therapeutic options.