https://pubmed.ncbi.nlm.nih.gov/33794217/ Drug reactions

J Pediatr. 2021 Mar 29;S0022-3476(21)00282-1.
doi: 10.1016/j.jpeds.2021.03.044.Online ahead of print.

Relative Risk Analysis of Liver-related Adverse Drug Reactions in Children Based on China's National Spontaneous Reporting System

Yu-Ming Guo 1, Fei-Lin Ge 1, Peng Xiong 1, Jing Jing 1, Ming Niu 1, Xu Zhao 1, Zhao-Fang Bai 1, Hai-Bo Song 2, Xiao-He Xiao 1, Jia-Bo Wang 3
Affiliations expand
Abstract

Objective: To compare the risk of liver-related adverse drug reactions (ADRs) in children and adults.

Study design: A case/non-case analysis on spontaneous reports based on the China National Adverse Drug Reactions Monitoring System database were conducted, focusing on events of liver-related ADRs in children under 14 years of age. Both, the relative risk of liver-related ADRs in children versus entire population and the risk stratification in children were expressed as a measure of disproportionality using the reporting odds ratio (ROR).

Results: There were 1,206 cases of pediatric liver-related ADRs identified from 2012 to 2016, accounting for 2.82% of the entire population. The highest ROR values in children from 0-14 years versus the entire population were observed for analgesics (3.97, 95% CI 3.27-4.81), respiratory (2.60, 95% CI 1.04-6.43), antineoplastic (2.29, 95% CI 2.02-2.58), immunomodulatory (1.91, 95% CI 1.44-2.53), and antimicrobial agents (1.47, 95% CI 1.33-1.63). Notably, infants from 0 to 1 year old showed significantly higher risk (3.14, 95% CI 2.85-3.48) of liver-related ADRs than the other age groups of children. For infants, analgesics (3.21, 95% CI 2.20-4.66) and antimicrobials (3.15, 95% CI 2.50-3.97) agents were found to have the highest adjusted RORs than other drug categories. The highest RORs were found for meropenem, amoxicillin, fluconazole, vancomycin, cefaclor, and ceftazidime in the antimicrobial agents for infants.

Conclusions: Children are sensitive to liver-related ADRs caused by several specific drug categories, and infants are the most sensitive.