Observational studyInternational journal of clinical pharmacy2023
Causality assessment of adverse drug reactions in neonates: a comparative study between Naranjo's algorithm and Du's tool.
Observational study in International journal of clinical pharmacy, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 1 of them a synthesis that pooled it.
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Who cites it
6 citing papers in PubMed, 1 synthesis or guideline pooled it, 6 citations in OpenAlex.
- Genetic polymorphisms and anti-tuberculosis drug-induced liver injury: an umbrella review of the evidence.International journal of clinical pharmacy · 2025Pooled it
- Adverse Drug Reactions in Neonates: How to Detect and Address Signals in the Noise.The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG · 2025Article
- Real-World Safety Profile of Proton Pump Inhibitors in Infants as Reported in the FDA Adverse Event Reporting System (FAERS): Tiny Tummies, Key Decisions.Pharmaceuticals (Basel, Switzerland) · 2025Article
- Assessment of severity and avoidability of adverse drug reactions in neonates: a reproducibility study of the Hartwig tool and LAAT.European journal of clinical pharmacology · 2025Observational
- Drug Safety During Breastfeeding: A Comparative Analysis of FDA Adverse Event Reports and LactMedPharmaceuticals (Basel, Switzerland) · 2024Article
- Causality Assessment Between Drugs and Fatal Cerebral Haemorrhage Using Electronic Medical Records: Comparative Evaluation of Disease-Specific and Conventional Methods.Drugs - real world outcomes · 2024Article
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Authors and funding
7 authors at 3 institutions in 1 country.
Funding
Abstract
backgroundAlgorithms for causality assessment of adverse drug reactions (ADRs) in a neonatal intensive care unit (NICU) are important in the management of adverse events, however, it is inconclusive which tool best suits pharmacovigilance in neonates.
aimTo compare the performance of the algorithms of Du and Naranjo in determining causality in cases of ADRs in neonates in a NICU.
methodThis observational and prospective study was conducted in a NICU of a Brazilian maternity school between January 2019 and December 2020. Independently, three clinical pharmacists used the algorithms of Naranjo and Du in 79 cases of ADRs in 57 neonates. The algorithms were evaluated for inter-rater and inter-tool agreement using Cohen's kappa coefficient (k).
resultsThe Du algorithm showed greater ability to identify definite ADRs (≈ 60%), but had low reproducibility (overall k = 0.108; 95% CI 0.064-0.149). In contrast, the Naranjo algorithm showed a lower proportion of definite ADRs (< 4%), but had good reproducibility (overall k = 0.402; 95% CI 0.379-0.429). The tools showed no significant correlation regarding ADR causality classification (overall k = - 0.031; 95% CI - 0.049 to 0.065).
conclusionAlthough the Du algorithm has a lower reproducibility compared to the Naranjo, this tool showed good sensitivity for classifying ADRs as definite, proving to be a more suitable tool for neonatal clinical routine.
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