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Updated: Apr 29, 2026
Assessment and Evaluation of the High Risk Neonate: The NICU Network Neurobehavioral Scale
Published on: August 25, 2014
Adverse drug reactions in neonates and infants: a population-tailored approach is needed
Karel Allegaert1,2, Johannes N van den Anker3,4,5,6
1Neonatal Intensive Care Unit, University Hospitals Leuven, Leuven, Belgium.
Insights
Improving infant drug safety requires tailored pharmacovigilance to prevent adverse drug reactions (ADRs). This involves specialized strategies for drug prescription, administration, and monitoring in neonates and infants.
Area of Science:
- Neonatal pharmacology and pharmacovigilance.
Background:
- Neonates and infants often receive off-label drug use with extrapolated dosages.
- Factors like immature organ function, polypharmacy, and specific illnesses increase adverse drug reaction (ADR) risks in this population.
- Current pharmacovigilance strategies are not adequately tailored for neonatal and infant populations.
Purpose of the Study:
- To highlight the urgent need for improved pharmacotherapy in neonates.
- To outline tailored strategies for the prevention and management of adverse drug reactions (ADRs) in infants.
- To emphasize the importance of developmental pharmacology and collaborative initiatives.
Main Methods:
- Illustrating prevention strategies for drug prescription and administration errors.
- Detailing detection methods using laboratory and clinical outlier data.
- Explaining assessment through algorithm scoring and understanding developmental toxicology.
- Proposing collaborative initiatives for guideline development.
Main Results:
- Tailored prevention strategies can address formulation and administration errors.
- Laboratory and clinical outlier data aid in ADR detection.
- Algorithmic scoring and developmental toxicology improve ADR assessment and prevention.
- Collaborative efforts are crucial for developing effective guidelines.
Conclusions:
- Specialized pharmacovigilance strategies are essential for neonates and infants.
- Addressing off-label use, dosing, and formulations is critical.
- Collaborative, multidisciplinary approaches promise to significantly improve infant pharmacotherapy and reduce ADRs.
Abstract:
Drug therapy is a powerful tool to improve outcome, but there is an urgent need to improve pharmacotherapy in neonates through tailored prevention and management of adverse drug reactions (ADRs). At present, infants commonly receive off-label drugs, at dosages extrapolated from those in children or adults. Besides the lack of labelling, inappropriate formulations, (poly)pharmacy, immature organ function and multiple illnesses further raise the risk for ADRs in neonates and infants. Pharmacovigilance to improve the prevention and management of ADRs needs to be tailored to neonates and infants. We illustrate this using prevention strategies for drug prescription and administration errors (e.g. formulation, bedside manipulation, access), detection through laboratory signalling or clinical outlier data (e.g. reference laboratory values, overall high morbidity), assessment through algorithm scoring (e.g. Naranjo or population specific), as well as understanding of the developmental toxicology (e.g. covariates, developmental pharmacology) to avoid re-occurrence and for development of guidelines. Such tailored strategies need collaborative initiatives to combine the knowledge and expertise of different disciplines, but hold promise to become a very effective tool to improve pharmacotherapy and reduce ADRs in infants.
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