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Safety of octreotide in hospitalized infants

Daniela Testoni1, Christoph P Hornik2, Megan L Neely3

  • 1Duke Clinical Research Institute, Durham, NC, United States; Division of Neonatal Medicine, Escola Paulista de Medicina, Universidade Federal de São Paulo, São Paulo, Brazil.

Early Human Development
|May 14, 2015
PubMed

Insights

Octreotide use in infants for off-label conditions like chylothorax showed a low rate of adverse events. Further research is needed to confirm safety, dosing, and efficacy in this population.

Area of Science:

  • Neonatal pharmacology
  • Pediatric critical care medicine

Background:

  • Octreotide is used off-label in infants for conditions including chylothorax, congenital hyperinsulinism, and gastrointestinal bleeding.
  • The safety profile of octreotide in hospitalized infants remains largely undescribed.

Purpose of the Study:

  • To describe the safety profile of octreotide in hospitalized infants.
  • To identify adverse events associated with off-label octreotide use in neonates.

Main Methods:

  • A retrospective cohort study identified 428 infants exposed to octreotide across 333 neonatal intensive care units.
  • Data on diagnoses, laboratory abnormalities, and clinical adverse events were collected from 1997 to 2012.

Main Results:

  • Common indications included chylothorax (50%), pleural effusion (32%), and hypoglycemia (22%).
  • Frequent laboratory adverse events were thrombocytopenia (47/1000 infant-days) and hyperkalemia (21/1000 infant-days).
  • Hypotension requiring pressors (12%) was the most common clinical adverse event; necrotizing enterocolitis occurred in 2% and death in 3% of infants.

Conclusions:

  • Off-label octreotide use in this infant cohort was associated with relatively few adverse events.
  • Further studies are necessary to fully evaluate octreotide's safety, optimal dosing, and efficacy in infants.
Abstract

Keywords:
Drug toxicityInfantOctreotideSafety

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