MEDLINE Journals

    Evaluation of naranjo adverse drug reactions probability scale in causality assessment of drug-induced liver injury.

    Authors
    García-Cortés M, Lucena MI, Pachkoria K, et al. 
    Source
    Aliment Pharmacol Ther 2008 May; 27(9) :780-9.
    Abstract

    Causality assessment in hepatotoxicity is challenging. The current standard liver-specific Council for International Organizations of Medical Sciences/Roussel Uclaf Causality Assessment Method scale is complex and difficult to implement in daily practice. The Naranjo Adverse Drug Reactions Probability Scale is a simple and widely used nonspecific scale, which has not been specifically evaluated in drug-induced liver injury.To compare the Naranjo method with the standard liver-specific Council for International Organizations of Medical Sciences/Roussel Uclaf Causality Assessment Method scale in evaluating the accuracy and reproducibility of Naranjo Adverse Drug Reactions Probability Scale in the diagnosis of hepatotoxicity.Two hundred and twenty-five cases of suspected hepatotoxicity submitted to a national registry were evaluated by two independent observers and assessed for between-observer and between-scale differences using percentages of agreement and the weighted kappa (kappa(w)) test.A total of 249 ratings were generated. Between-observer agreement was 45% with a kappa(w) value of 0.17 for the Naranjo Adverse Drug Reactions Probability Scale, while there was a higher agreement when using the Council for International Organizations of Medical Sciences/Roussel Uclaf Causality Assessment Method scale (72%, kappa(w): 0.71). Concordance between the two scales was 24% (kappa(w): 0.15). The Naranjo Adverse Drug Reactions Probability Scale had low sensitivity (54%) and poor negative predictive value (29%) and showed a limited capability to distinguish between adjacent categories of probability.The Naranjo scale lacks validity and reproducibility in the attribution of causality in hepatotoxicity.

    Mesh
    Adverse Drug Reaction Reporting Systems
    Drug-Induced Liver Injury
    Drug-Related Side Effects and Adverse Reactions
    Humans
    Liver
    Liver Function Tests
    Severity of Illness Index
    Spain
    Statistics as Topic
    Toxicity Tests
    Language

    eng

    Pub Type(s)
    Journal Article
    PubMed ID

    18284654

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