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Updated: Jun 30, 2026

Assessment and Evaluation of the High Risk Neonate: The NICU Network Neurobehavioral Scale
Published on: August 25, 2014
Adverse drug reactions from birth to early childhood
1Department of Pediatrics, Hospital for Sick Children, University of Toronto, Ontario, Canada.
Insights
Infants and children face unique drug risks, with adverse drug reactions impacting development. Continued vigilance is crucial to prevent and manage these reactions, learning from past errors to protect child health.
Area of Science:
- Pediatric Pharmacology
- Neonatal and Infant Health
- Drug Safety and Development
Background:
- Neonates and infants possess unique physiological characteristics differentiating them from older children and adults.
- Drug exposure during intrauterine, neonatal, and infancy periods can lead to significant immediate, delayed, and long-term developmental consequences.
- Pharmacotherapy in neonates and infants is often complex, increasing the risk of adverse drug reactions (ADRs) due to their fragility and illness severity.
Purpose of the Study:
- To highlight the distinct nature and implications of adverse drug reactions in neonates and infants.
- To emphasize the differences in ADRs experienced by pediatric populations compared to adults.
- To underscore the ongoing need for vigilance in preventing and managing pediatric adverse drug reactions.
Main Methods:
- Review of existing literature on pediatric adverse drug reactions.
- Analysis of historical drug safety incidents involving children.
- Discussion of the unique pharmacokinetic and pharmacodynamic considerations in pediatric drug therapy.
Main Results:
- Adverse drug reactions in infants and children can have profound and unpredictable effects on neurologic and somatic development.
- Differences in morphology, disease processes, and treatments lead to a distinct spectrum of ADRs in pediatric populations.
- Despite advancements, children continue to be vulnerable to medication misadventures, including historical contaminants like diethylene glycol.
Conclusions:
- Pediatric adverse drug reactions require specialized attention due to unique patient factors and developmental implications.
- Continuous vigilance, education, and learning from past drug safety failures are essential for improving child health outcomes.
- Healthcare professionals must remain proactive in the prevention, monitoring, and treatment of adverse drug reactions in neonates and infants.
Abstract:
Neonates and older infants are a diverse group of children, quite different from their older counterparts. Adverse drug reactions may have profound immediate, delayed, and long-term implications for their neurologic and somatic development. The intrauterine, neonatal, and infancy periods are the only stages in life in which one is exposed to and affected by drugs administered to another person, the mother. In addition, because of the fragility of the neonate and the complexity of their illnesses, their pharmacotherapy is frequently complicated with misadventure and adverse drug reactions that are unavoidable or difficult to assess. Because of their differences in morphology and disease process and treatments, infants and children experience a different range of adverse drug reactions. These reactions are not necessarily predictable from the adult experience. Despite the advances made in the field of pediatric adverse drug reactions and the lessons learned through the misfortunes involving children, children continue to suffer. Sixty years after the Elixir of Sulfanilamide-Massengill disaster, children continue to be given medications with diethylene glycol in developing countries. Pediatricians, pharmacologists, and others must continue to be vigilant and active in preventing, monitoring, and treating adverse drug reactions in children. Learning from mistakes of the past will improve the health of children by preventing mistakes in the future.
Related Concept Videos
Factors Affecting Drug Response: Overview
Pharmacokinetics in Pediatric Patients: Drug Metabolism
Drug Toxicity: Overview
Drug Toxicity: Risk factors
Drug Toxicity: Allergic Reactions
Drug toxicity: Idiosyncratic Reactions

