Analysis of Adverse Reactions Associated with Parenteral Nutrition Use in Korea

ABSTRACT

PURPOSE: To evaluate the clinical manifestations of adverse drug reactions (ADRs) of parenteral nutrition (PN) use in Korea. METHODS: The Korean Adverse Event Reporting System (KAERS) database records in 2015 on PN-treated patients were used. ADRs classified as “certain,”“probable,” and “possible” based on the WHO-Uppsala Monitoring Centre criteria were analyzed. RESULTS: In total, 21,436 ADRs from 2,346 patients were included for analysis. The mean patient age was 57.1 years and the mean number of ADRs per patient was 9.1. ADRs were reported frequently with amino acids solutions (682 events, 40.8%), followed by combinations products (519 events, 31.1%), and fat emulsions (363 events, 21.7%). The frequent ADRs were gastrointestinal (507 events, 30.3%), skin (343 events, 20.5%), general disorders (239 events, 14.3%), and central/peripheral nervous system disorders (165 events, 9.9%). The common clinical symptoms were nausea (321 events, 19.2%), vomiting (105 events, 6.3%), and vein pain (102 events, 6.1%). Serious ADRs accounted for 220 patients (9.4%) and dyspnea was the most frequent clinical manifestation. CONCLUSION: This study analyzed the KAERS data in 2015 from patients treated with PN and revealed gastrointestinal and skin disorders to be the leading ADRs.