TY  - JOUR
A1  - Teschke, Rolf
A1  - Schulze, Johannes B.
A1  - Eickhoff, Axel Stefan
A1  - Danan, Gaby
T1  - Drug induced liver injury : can biomarkers assist RUCAM in causality assessment?
T2  - International journal of molecular sciences
N2  - Drug induced liver injury (DILI) is a potentially serious adverse reaction in a few susceptible individuals under therapy by various drugs. Health care professionals facing DILI are confronted with a wealth of drug-unrelated liver diseases with high incidence and prevalence rates, which can confound the DILI diagnosis. Searching for alternative causes is a key element of RUCAM (Roussel Uclaf Causality Assessment Method) to assess rigorously causality in suspected DILI cases. Diagnostic biomarkers as blood tests would be a great help to clinicians, regulators, and pharmaceutical industry would be more comfortable if, in addition to RUCAM, causality of DILI can be confirmed. High specificity and sensitivity are required for any diagnostic biomarker. Although some risk factors are available to evaluate liver safety of drugs in patients, no valid diagnostic or prognostic biomarker exists currently for idiosyncratic DILI when a liver injury occurred. Identifying a biomarker in idiosyncratic DILI requires detailed knowledge of cellular and biochemical disturbances leading to apoptosis or cell necrosis and causing leakage of specific products in blood. As idiosyncratic DILI is typically a human disease and hardly reproducible in animals, pathogenetic events and resulting possible biomarkers remain largely undisclosed. Potential new diagnostic biomarkers should be evaluated in patients with DILI and RUCAM-based established causality. In conclusion, causality assessment in cases of suspected idiosyncratic DILI is still best achieved using RUCAM since specific biomarkers as diagnostic blood tests that could enhance RUCAM results are not yet available.
KW  - drug induced liver injury
KW  - DILI
KW  - RUCAM
KW  - Roussel Uclaf Causality Assessment Method
KW  - diagnostic biomarkers
KW  - pathogenesis
Y1  - 2017
UR  - http://publikationen.ub.uni-frankfurt.de/frontdoor/index/index/docId/44124
UR  - https://nbn-resolving.org/urn:nbn:de:hebis:30:3-441249
SN  - 1422-0067
SN  - 1661-6596
N1  - © 2017 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (http://creativecommons.org/licenses/by/4.0/)
VL  - 18
IS  - 4, Art. 803
SP  - 1
EP  - 23
PB  - Molecular Diversity Preservation International
CY  - Basel
ER  -