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LiverTox: Clinical and Research Information on Drug-Induced Liver Injury [Internet]. Bethesda (MD): National Institute of Diabetes and Digestive and Kidney Diseases; 2012-.

LiverTox: Clinical and Research Information on Drug-Induced Liver Injury [Internet].
Show detailsDrug induced liver injury is a diagnosis of exclusion that rests upon ruling out other common causes of liver disease, and knowledge of the pattern of injury associated with the specific drug. Unlike in hepatitis A or B, for instance, there are no specific diagnostic tests that establish causality for drug induced liver injury. The diagnosis can also be very challenging and even experts can disagree on the likelihood of the causality. For these reasons, attempts have been made to standardize causality assessment in drug induced adverse events including hepatotoxicity. These "instruments" generally rely upon careful delineation of the timing of onset of the adverse event in relation to starting the medication (challenge), and the timing of resolution in relation to stopping the medication (dechallenge). The causality is greatly strengthened if there is a recurrence on reexposure (rechallenge). Other helpful features are signs and symptoms of hypersensitivity, know drug allergies, the absence of competing diagnoses, and previous information on the occurrence of a similar adverse event with the medication. These factors are variously captured in the causality instruments and given various weights to achieve a rating score for the likelihood of the medication causing the injury. Commonly used instruments include the Naranjo Probability Scale, which is not specific to liver injury and can be used for any type of adverse drug reaction. In contrast, the Roussel Uclaf Causality Assessment Method (RUCAM) and its modification known as the Maria and Victorino (M & V) System, were developed specifically for drug induced liver injury. All three causality instruments have been used widely and perform reasonably well in comparison to the "gold standard" of expert opinion. These three causality assessment tools are discussed in detail in the links below, and the actual forms are provided in pdf files that can be printed. In addition, guidance is provided on how to fill out the forms. A computerized version of the RUCAM scale is used in the section of LiverTox called "Submit a Case Report." However, subjective features of all of the causality assessment instruments make computerized computations difficult and not as reliable as individual assignment of scores on the forms.
- Review Tools for causality assessment in drug-induced liver disease.[Curr Opin Gastroenterol. 2019]Review Tools for causality assessment in drug-induced liver disease.Tillmann HL, Suzuki A, Barnhart HX, Serrano J, Rockey DC. Curr Opin Gastroenterol. 2019 May; 35(3):183-190.
- Review Toward Kidney-Specific Causality Assessment Tool.[Clin Ther. 2022]Review Toward Kidney-Specific Causality Assessment Tool.Kaya M, Duru M, Gulmez SE. Clin Ther. 2022 Jul; 44(7):e59-e75. Epub 2022 Jun 18.
- Review Causality assessment of adverse drug reaction: A narrative review to find the most exhaustive and easy-to-use tool in post-authorization settings.[J Appl Biomed. 2023]Review Causality assessment of adverse drug reaction: A narrative review to find the most exhaustive and easy-to-use tool in post-authorization settings.Pradhan P, Lavallee M, Akinola S, Escobar Gimenes FR, Berard A, Methot J, Piche ME, Gonella JM, Cloutier L, Leclerc J. J Appl Biomed. 2023 Jun; 21(2):59-66. Epub 2023 Jun 21.
- Review Dilemmas of the causality assessment tools in the diagnosis of adverse drug reactions.[Saudi Pharm J. 2016]Review Dilemmas of the causality assessment tools in the diagnosis of adverse drug reactions.Khan LM, Al-Harthi SE, Osman AM, Sattar MA, Ali AS. Saudi Pharm J. 2016 Jul; 24(4):485-93. Epub 2015 Jan 10.
- Comparison of the Liverpool Causality Assessment Tool vs. the Naranjo Scale for predicting the likelihood of an adverse drug reaction: A retrospective cohort study.[Br J Clin Pharmacol. 2023]Comparison of the Liverpool Causality Assessment Tool vs. the Naranjo Scale for predicting the likelihood of an adverse drug reaction: A retrospective cohort study.Um SH, Abuzgaia A, Rieder M. Br J Clin Pharmacol. 2023 Aug; 89(8):2407-2412. Epub 2023 Mar 22.
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