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Dhruv Balkindi MD, Guest Editor
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Off-Label Medication Use in NICU
Kumar P, Walker J,Hurt K et al. Medication Use in the Neonatal Intensive Care Unit: Current Patterns and Off-Label Use of Parenteral Medications. J Pediatr (March 2008);152: 412-415. Full Text | PDF (92 KB)
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.
Results. 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.
Comments: The authors studied the commonly used medications in a level III NICU and determined which of these drugs that have been approved by FDA. It is of interest to note that approximately half (45%) of the medications used in the NICUs are off label. On the other hand it is reassuring that majority of the antibiotics were FDA approved. In contrast majority of the off label medications were parenteral medications which include analgesics, vasopressors and hematolgic agents. However most of the off label drugs (90%) have at least one randomized clinical trial to support their efficacy and safety. There is a still a need for more systematic studies. DB
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