Objectives: To study the current patterns of medication use, assess the extent of off-label parenteral medication use, and evaluate evidence for efficacy and safety of parenteral medications used off-label in neonates.
Study design: We collected information on all medications dispensed for infants admitted to an urban tertiary care neonatal intensive care unit over a 3-year period. Parenteral drugs were reviewed for off-label use, and medications not approved for use in neonates were evaluated for evidence of efficacy and safety in neonates.
Results: The ranges of gestational age, length of stay, and number of medications per infant were 23 to 42 weeks, 1 to 190 days, and 1 to 62, respectively, for 2304 admissions during the study period. Infants with lower birth weight and shorter gestational age received more medications compared with more mature infants. Of 61 parenteral medications evaluated, 27 (45%) were used off-label in neonates. Food and Drug Administration (FDA) approval for use in neonatal period was highest for antibiotics (14/16); the parenteral medications most frequently used off-label were analgesics, vasopressors, and hematologic agents.
Conclusions: Critically ill neonates are exposed to numerous medications, a significant proportion of which are not yet FDA-approved for use in this vulnerable group of patients.