Adverse drug reactions in neonatal intensive care unit: Characteristics and risk factors

Abstract

Adverse drug reactions (ADRs) in neonates can significantly affect expected clinical outcomes. The aim of this study was to analyze the prevalence and characteristics of ADRs and identify the risk factors involved in a neonatal intensive care unit (NICU). A prospective cohort study based on intensive pharmacovigilance was carried out in NICU of a public teaching hospital in the south of Mexico. Neonates admitted to the NICU who had between 1 and 90 days of age, with at least 24 hours of hospitalization, and a confirmed suspicion of ADRs were included. The prevalence and characteristics of ADRs were analyzed. Relative ratios (RR) were estimated with 95% confidence intervals (CI) to evaluate the risk factors of ADRs (p˂0.05). 998 newborns were included, 109 ADRs were detected in 75 newborns, the cumulative incidence was 7.51% and the ADRs were mainly probable imputability and moderate severity. The therapeutic group most frequently related to the development of ADRs was anti-infectives for systemic use and the blood and lymphatic system was most affected by the ADRs. Identified risk factors were: female sex (RR 1.58; 95% CI 1.01-2.47), prematurity (RR 5.6; 95% CI 3.45-9.11), low birth weight (RR 2.52; 95% CI 1.63-3.91), length of hospitalization >15 days (RR 12.95; 95% CI 7.89-21.25) and drugs administered >5 (RR 5.92; 95% CI 2.6-13.48). These results should be considered and studied in greater depth, which will allow the prevention of the development of ADRs in this group of patients.