The diagnosis and management of idiosyncratic drug‐induced liver injury

Hassan, Ammar; Fontana, Robert J.

doi:10.1111/liv.13931

Cited by 63 publications

(43 citation statements)

References 93 publications

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“…Responses to comments on the original version of RUCAM of 1993 (Hassan and Fontana, 2019) were provided and already implemented in the updated version (Danan and Teschke, 2016). Other comments were addressed in a summary table (Danan and Teschke, 2018) and in detailed work instructions (Electronic supplementary material in Danan and Teschke, 2018).…”

Section: Future Use Of Rucammentioning

confidence: 99%

Roussel Uclaf Causality Assessment Method for Drug-Induced Liver Injury: Present and Future

Danan¹,

Teschke

2019

Front. Pharmacol.

104

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Among the causality assessment methods used for the diagnosis of drug-induced liver injury (DILI), Roussel Uclaf Causality Assessment Method (RUCAM) remains the most widely used not only for individual cases but also for prospective and retrospective studies worldwide. This first place is justified by the characteristics of the method such as precise definition and classification of the liver injury, which determines the right scale in the scoring system, precise definition of the seven criteria, and the validation approach based on cases with positive rechallenge. RUCAM is used not only for any types of drugs but also for herbal medicines causing herb-induced liver injury, (HILI) and dietary supplements. In 2016, the updated RUCAM provided further specifications of criteria and instructions to improve interobserver variability. Although this method was criticized for criteria such as the age and alcohol consumption, recent consensus meeting of experts has recognized their value and recommended their incorporation into any method. While early studies searching for DILI in large databases especially in electronic medical records were based on codes of diseases or natural language without causality assessment, the recommendation is now to include RUCAM in the search for DILI/HILI. There are still studies on DILI detection or the identification of biomarkers that take into consideration the cases assessed as “possible,” although it is well known that these cases reduce the strength of the association between the cases and the offending compound or the new biomarker to be validated. Attempts to build electronic RUCAM or automatized application of this method were successful despite some weaknesses to be corrected. In the future, more reflections are needed on an expert system to standardize the exclusion of alternative causes according to the clinical context. Education and training on RUCAM should be encouraged to improve the results of the studies and the day-to-day work in pharmacovigilance departments in companies or in regulatory agencies. It is also expected to improve RUCAM with biomarkers or other criteria provided that the validation process replaces expert opinion by robust standards such as those used for the original method.

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Section: Future Use Of Rucammentioning

confidence: 99%

Roussel Uclaf Causality Assessment Method for Drug-Induced Liver Injury: Present and Future

Danan¹,

Teschke

2019

Front. Pharmacol.

104

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“…Patients with acute hepatitis and elevated prothrombin time or international normalized ratio levels without mental status changes are frequently labeled as having a severe acute liver injury[25].…”

Section: Definitionsmentioning

confidence: 99%

Liver involvement in the drug reaction, eosinophilia, and systemic symptoms syndrome

Martínez-Cabriales

Shear

González-Moreno

2019

WJCC

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First described in 1996, the drug reaction, eosinophilia, and systemic symptoms syndrome (DReSS) is considered, along with Stevens-Johnson syndrome and toxic epidermal necrolysis, a severe cutaneous drug reaction. It is characterized by the presence of a maculopapular erythematous skin eruption, fever, lymphadenopathy, influenza-like symptoms, eosinophilia, and visceral involvement such as hepatitis, pneumonitis, myocarditis, pericarditis, nephritis, and colitis. The prognosis of patients with DReSS is related to the severity of visceral involvement. The mortality ranges from approximately 5% to 10%, and death is mainly due to liver failure, which is also the organ most commonly involved in this syndrome. Although it was previously hypothesized in 1994, DReSS syndrome can lead to reactivation of one or more human herpesvirus family members. Now being included as diagnostic criteria in a proposed diagnostic score system, this reactivation can be detected up to 2-3 wk after DReSS syndrome onset. Other causes of mortality in DReSS syndrome include myocardial or pulmonary lesions and hemophagocytosis. We reviewed the literature of previously reported case-series of DReSS and liver involvement, highlighting the pattern of liver damage, the treatment used, and the outcome.

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“…We followed the definition of chronic DILI of the American College of Gastroenterology Clinical Guideline, if LFTs did not return to normal within 6 months after drug withdrawal, regardless of the types of liver injury. Based on the definition of chronic DILI, the incidence of chronic DILI was up to 23.6%, which was higher than the known incidence in the other registrations . The latest research of DILIN workshop showed an incidence of 17% of chronic DILI .…”

Section: Discussionmentioning

confidence: 80%

Prolonged interval of total bilirubin decline is an early independent predictive factor of chronic persistent drug‐induced liver injury

Zhu

Wang

Zhao

et al. 2019

Hepatology Research

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Aim Chronic drug‐induced liver injury (DILI) with persistent abnormal liver function tests (LFTs) >6 months after cessation of the insulting drugs could progress to cirrhosis. The aim of the present study was to identify the risk factors of chronic DILI for early recognition and better management. Methods History of drug intake and results of LFTs were retrospectively retrieved for patients with a discharge diagnosis of DILI for at least 1‐year follow up. The risk factors independently associated with chronic DILI were analyzed by multiple logistic regression analyses. Results A total of 33 of the 140 DILI patients had persistent abnormal LFTs >6 months, which were considered as chronic DILI. It was found that the time intervals of alanine aminotransferase and total bilirubin decline from the peak to their half peak (T0.5ALT, T0.5TBIL) were significantly longer in the chronic DILI group than that in the recovered group (P = 0.001 and P < 0.001). The risk factors associated with chronic DILI independently were T0.5TBIL (OR 1.315, 95% CI 1.038–1.668), longer period of insulting drug(s) intake (OR 1.018, 95% CI 1.003–1.033), mixed/cholestatic pattern (OR 97.159, 95% CI 1.866–5005.994). More importantly, receiver operating characteristic curve analysis showed that the prognostic value of T0.5TBIL for chronic DILI had a sensitivity of 60.0% at a specificity of 90.7% with the threshold of 16 days. Conclusions The time intervals of total bilirubin decline from its peak to half of its peak (T0.5TBIL) was an early independent predictive factor of chronic DILI, suggesting that T0.5TBIL might serve as an indicator for chronicity.

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The diagnosis and management of idiosyncratic drug‐induced liver injury

Cited by 63 publications

References 93 publications

Roussel Uclaf Causality Assessment Method for Drug-Induced Liver Injury: Present and Future

Roussel Uclaf Causality Assessment Method for Drug-Induced Liver Injury: Present and Future

Liver involvement in the drug reaction, eosinophilia, and systemic symptoms syndrome

Prolonged interval of total bilirubin decline is an early independent predictive factor of chronic persistent drug‐induced liver injury

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