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 37 wks) the ADR relative risk was 0.5 . Diseases of prematurity (resp. distress syndrome, intraventricular hemorrhage, apnea, necrotizing enterocolitis) were significantly (p 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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