Abstract
Factors associated with occurrence of adverse drug reactions (ADR - abnormal event(s) validated to be due to drugs) were evaluated in an intensive prospective epidemiologic study of 1200 neonates consecutively admitted to a neonatal intensive care unit. An MD/nurse team recorded and computerized all pertinent biographic, clinical, laboratory and medication data. 326/1200 (27.1%) neonates developed at least one ADR; 153 of whom had moderate to severe (fatal or life-threatening) ADR. Comparison of patients with ADR and those without ADR showed that ADR patients had significantly lower birthweights and gestational age with longer duration of hospitalization. Neonates <28 weeks gestation have 9-fold risk of ADR. Conversely, for term infants(>37 wks) the ADR relative risk was 0.5 . Diseases of prematurity (resp. distress syndrome, intraventricular hemorrhage, apnea, necrotizing enterocolitis) were significantly (p<0.001) associated with an increased risk ADR occurrence. Mechanical ventilation and total IV nutrition increased the risk of ADR; 3.6 and 5.4 (p<0.001) respectively. Hyperbilirubinemia (>12 or >15 mg/dl) was not a risk factor, but abnormal liver function (SGOT >100 units) increased the risk 9.6 fold. Abnormal kidney function (BUN >30 mg/dl, serum creatinine >1.2 mg/dl) also increased ADR risk 9 fold (p<0.001). We conclude that the sick low birth weight neonate receiving mechanical ventilation who has abnormal renal or liver function is at greatest risk for ADR.
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Aranda, J., Seliske, P., Horton, L. et al. RISK FACTORS IN NEONATAL ADVERSE DRUG REACTIONS. Pediatr Res 18 (Suppl 4), 149 (1984). https://doi.org/10.1203/00006450-198404001-00334
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DOI: https://doi.org/10.1203/00006450-198404001-00334
