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Risperidone medication errors in children: an analysis of French poison centres data
Thierry Vial1, Anne-Marie Patat1, Nathalie Paret1
1a Department of Pharmacotoxicology , Lyon University Hospital, Hospices Civils de Lyon , France.
Clinical Toxicology (Philadelphia, Pa.)
|November 20, 2018
Summary
Risperidone medication errors in children generally cause mild effects like somnolence and minor extrapyramidal symptoms. Severe toxicity was not observed, suggesting home surveillance is possible for low-dose exposures.
Area of Science:
- Pediatric Toxicology
- Pharmacovigilance
- Adverse Drug Reactions
Background:
- Medication errors involving antipsychotics in children require careful evaluation.
- Risperidone is frequently prescribed for various pediatric conditions.
Purpose of the Study:
- To characterize clinical outcomes of risperidone medication errors in children under 13.
- To determine a safe threshold for home observation after accidental overdose.
Main Methods:
- Retrospective analysis of 160 risperidone medication error cases managed by French Poison Centres (2001-2012).
- Inclusion criteria focused on delayed reporting, exceeding twice the maximal daily dose, or symptomatic presentation.
- Data collected on patient demographics, ingested dose, and clinical effects.
Main Results:
- The median ingested dose was 0.1 mg/kg (3.3 times the maximum recommended dose).
- Most children experienced minor symptoms (59% somnolence/sedation, 10.6% extrapyramidal disorders).
- No severe toxicity, cardiac, or significant neurological events were reported.
Conclusions:
- Risperidone medication errors in children typically result in minimal clinical effects.
- Somnolence and mild-to-moderate extrapyramidal symptoms are the primary concerns.
- Home surveillance is a viable option for children ingesting ≤0.15 mg/kg of risperidone.
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