Abstract
Data quality of idiosyncratic drug-induced liver injury (iDILI) cases is insufficient in the US LiverTox database due to the lack of a robust causality assessment method such as the Roussel Uclaf Causality Assessment Method (RUCAM), not allowing for appropriate use of included cases by physicians. Despite some shortcomings, case quality is much better in national DILI registries using the prospective RUCAM, with a few exemptions.
Keywords: CAMs, causality assessment methods, DILI, drug-induced liver injury, HILI, herb induced liver injury, Roussel Uclaf Causality Assessment Method, RUCAM, DILI registries, LiverTox.
[1]
Ke, L.; Lu, C.; Shen, R.; Lu, T.; Ma, B.; Hua, Y. Knowledge mapping of drug-induced liver injury: a scientometric investigation (2010-2019). Front. Pharmacol., 2020, 11, 842.
[http://dx.doi.org/10.3389/fphar.2020.00842] [PMID: 32581801]
[http://dx.doi.org/10.3389/fphar.2020.00842] [PMID: 32581801]
[2]
Andrade, R.J.; Lucena, M.I.; Fernández, M.C. Spanish Group for the Study of Drug-Induced Liver Disease. Drug-induced liver injury: an analysis of 461 incidences submitted to the Spanish registry over a 10-year period. Gastroenterology, 2005, 129(2), 512-521.
[http://dx.doi.org/10.1016/j.gastro.2005.05.006] [PMID: 16083708]
[http://dx.doi.org/10.1016/j.gastro.2005.05.006] [PMID: 16083708]
[3]
Danan, G.; Bénichou, C. Causality assessment of adverse reactions to drugs--I. A novel method based on the conclusions of international consensus meetings: application to drug-induced liver injuries. J. Clin. Epidemiol., 1993, 46(11), 1323-1330.
[http://dx.doi.org/10.1016/0895-4356(93)90101-6] [PMID: 8229110]
[http://dx.doi.org/10.1016/0895-4356(93)90101-6] [PMID: 8229110]
[4]
Benichou, C.; Danan, G.; Flahault, A. Causality assessment of adverse reactions to drugs--II. An original model for validation of drug causality assessment methods: case reports with positive rechallenge. J. Clin. Epidemiol., 1993, 46(11), 1331-1336.
[http://dx.doi.org/10.1016/0895-4356(93)90102-7] [PMID: 8229111]
[http://dx.doi.org/10.1016/0895-4356(93)90102-7] [PMID: 8229111]
[5]
Danan, G.; Teschke, R. RUCAM in drug and herb induced liver injury: The update. In: In: Special Issue “Drug, Herb, and Dietary Supplement Hepatotoxicity”Int J Mol Sci; , 2016; 17, p. (1)14.
[http://dx.doi.org/10.3390/ijms17010014]
[http://dx.doi.org/10.3390/ijms17010014]
[6]
Teschke, R.; Danan, G. Worldwide use of RUCAM for causality assessment in 81,856 DILI and 14,029 HILI cases published 1993 - mid 2020: A comprehensive analysis. Medicines (Basel), 2020, 7(10), 62.
[http://dx.doi.org/10.3390/medicines7100062] [PMID: 33003400]
[http://dx.doi.org/10.3390/medicines7100062] [PMID: 33003400]
[7]
Aithal, G.P.; Watkins, P.B.; Andrade, R.J. Case definition and phenotype standardization in drug-induced liver injury. Clin. Pharmacol. Ther., 2011, 89(6), 806-815.
[http://dx.doi.org/10.1038/clpt.2011.58] [PMID: 21544079]
[http://dx.doi.org/10.1038/clpt.2011.58] [PMID: 21544079]
[8]
Shen, T.; Liu, Y.; Shang, J. Incidence and etiology of drug-induced liver injury in Mainland China. Gastroenterology, 2019, 156(8), 2230-2241.e11.
[http://dx.doi.org/10.1053/j.gastro.2019.02.002] [PMID: 30742832]
[http://dx.doi.org/10.1053/j.gastro.2019.02.002] [PMID: 30742832]
[9]
Rosenberg, J.J.; Higley, C.; Shabazi, S.; Lewis, J.H. Selected highlights and controversies of drug-induced liver injury from the recent literature. World J Gastroenterol Hepatol Endosc Res, 2020, 1, 1-16.
[10]
Robles-Diaz, M.; Lucena, M.I.; Kaplowitz, N. Spanish DILI Registry; SLatinDILI Network; Safer and Faster Evidence-based Translation Consortium. Use of Hy’s law and a new composite algorithm to predict acute liver failure in patients with drug-induced liver injury. Gastroenterology, 2014, 147(1), 109-118.e5.
[http://dx.doi.org/10.1053/j.gastro.2014.03.050] [PMID: 24704526]
[http://dx.doi.org/10.1053/j.gastro.2014.03.050] [PMID: 24704526]
[11]
Lo Re, V., III; Forde, K.A.; Lewis, J.D. Reply. Clin. Gastroenterol. Hepatol., 2016, 14(6), 918-919.
[http://dx.doi.org/10.1016/j.cgh.2016.02.013] [PMID: 26883072]
[http://dx.doi.org/10.1016/j.cgh.2016.02.013] [PMID: 26883072]
[12]
Regev, A.; Björnsson, E.S. Drug-induced liver injury: morbidity, mortality, and Hy’s law. Gastroenterology, 2014, 147(1), 20-24.
[http://dx.doi.org/10.1053/j.gastro.2014.05.027] [PMID: 24880009]
[http://dx.doi.org/10.1053/j.gastro.2014.05.027] [PMID: 24880009]
[13]
Tillmann, H.L.; Rockey, D.C. Improved prediction of the need for liver transplantation in patients with drug-induced liver injury? Gastroenterology, 2014, 147(6), 1441.
[http://dx.doi.org/10.1053/j.gastro.2014.07.059] [PMID: 25450085]
[http://dx.doi.org/10.1053/j.gastro.2014.07.059] [PMID: 25450085]
[14]
Tansel, A.; Kanwal, F.; Hollinger, F.B. Use of Hy’s Law, R criteria, and nR criteria to predict acute liver failure or transplantation in patients with drug-induced liver injury. Gastroenterology, 2015, 148(2), 452.
[http://dx.doi.org/10.1053/j.gastro.2014.11.046] [PMID: 25532807]
[http://dx.doi.org/10.1053/j.gastro.2014.11.046] [PMID: 25532807]
[15]
Teschke, R.; Andrade, R.J. Drug-induced liver injury: expanding our knowledge by enlarging population analysis with prospective and scoring causality assessment. Gastroenterology, 2015, 148(7), 1271-1273.
[http://dx.doi.org/10.1053/j.gastro.2015.04.027] [PMID: 25921378]
[http://dx.doi.org/10.1053/j.gastro.2015.04.027] [PMID: 25921378]
[16]
Bessone, F.; Hernandez, N.; Dávalos, M. Building a Spanish-Latin American network on drug induced liver injury: much to get from a joint collaborative initiative. Ann. Hepatol., 2012, 11(4), 544-549.
[http://dx.doi.org/10.1016/S1665-2681(19)31469-3] [PMID: 22710943]
[http://dx.doi.org/10.1016/S1665-2681(19)31469-3] [PMID: 22710943]
[17]
Bessone, F.; Hernandez, N.; Lucena, M.I.; Andrade, R.J. Latin Dili Network Latindilin And Spanish Dili Registry. The Latin American DILI Registry experience: A successful ongoing collaborative strategic initiative. Int. J. Mol. Sci., 2016, 17(3), 313.
[http://dx.doi.org/10.3390/ijms17030313] [PMID: 26938524]
[http://dx.doi.org/10.3390/ijms17030313] [PMID: 26938524]
[18]
Bessone, F.; Robles-Diaz, M.; Hernandez, N.; Medina-Caliz, I.; Lucena, M.I.; Andrade, R.J. Assessment of serious acute and chronic idiosyncratic drug-induced liver injury in clinical practice. Semin. Liver Dis., 2019, 39(3), 381-394.
[http://dx.doi.org/10.1055/s-0039-1685519] [PMID: 31049898]
[http://dx.doi.org/10.1055/s-0039-1685519] [PMID: 31049898]
[19]
Teschke, R.; Andrade, R.J. Drug, Herb, and Dietary Supplement Hepatotoxicity. Int. J. Mol. Sci., 2016, 17(9), 1488.http://www.mdpi.com/journal/ijms/special_issues/Hepatotoxicity
[http://dx.doi.org/10.3390/ijms17091488] [PMID: 27608014]
[http://dx.doi.org/10.3390/ijms17091488] [PMID: 27608014]
[20]
Teschke, R.; Schmidt, M. Controversy on a newly published case of assumed acute liver failure one day after kava use: issues of confounders, causality, and an undetermined cause. J Mod Med Chem, 2020, 8, 33-40.
[http://dx.doi.org/10.12970/2308-8044.2020.08.04]
[http://dx.doi.org/10.12970/2308-8044.2020.08.04]
[21]
Björnsson, E.S. Hepatotoxicity by drugs: the most common implicated agents. In: Special Issue “Drug, Herb, and Dietary Supplement Hepatotoxicity. In: Int. J. Mol. Sci; , 2016; 17, p. 224.
[http://dx.doi.org/10.3390/ijms17020224]
[http://dx.doi.org/10.3390/ijms17020224]
[22]
Björnsson, E.S.; Hoofnagle, J.H. Categorization of drugs implicated in causing liver injury: Critical assessment based on published case reports. Hepatology, 2016, 63(2), 590-603.
[http://dx.doi.org/10.1002/hep.28323] [PMID: 26517184]
[http://dx.doi.org/10.1002/hep.28323] [PMID: 26517184]
[23]
Teschke, R. Top-ranking drugs out of 3312 drug-induced liver injury cases evaluated by the Roussel Uclaf Causality Assessment Method. Expert Opin. Drug Metab. Toxicol., 2018, 14(11), 1169-1187.
[http://dx.doi.org/10.1080/17425255.2018.1539077] [PMID: 30354694]
[http://dx.doi.org/10.1080/17425255.2018.1539077] [PMID: 30354694]
[24]
Teschke, R.; Schulze, J.; Eickhoff, A.; Danan, G. Drug induced liver injury: Can biomarkers assist RUCAM in causality assessment? Special issue: Molecular Research on Drug Induced Liver Injury. Int. J. Mol. Sci., 2017, 18, 803.
[http://dx.doi.org/10.3390/ijms180408038]
[http://dx.doi.org/10.3390/ijms180408038]
[25]
Teschke, R.; Eickhoff, A.; Brown, A.C.; Neuman, M.G.; Schulze, J. Diagnostic biomarkers in liver injury by drugs, herbs, and alcohol: Tricky dilemma after EMA correctly and officially retracted Letter of Support. Int. J. Mol. Sci., 2019, 21(1), 212.
[http://dx.doi.org/10.3390/ijms21010212] [PMID: 31892250]
[http://dx.doi.org/10.3390/ijms21010212] [PMID: 31892250]
[26]
Teschke, R. Idiosyncratic DILI: Analysis of 46,266 cases assessed for causality by RUCAM and published from 2014 to early 2019. In: Special issue: Clinical drug induced liver injury: Current diagnostic and mechanistic challenges. In: Front Pharmacol; , 2019.
[http://dx.doi.org/10.389/fphar.2019.00730]
[http://dx.doi.org/10.389/fphar.2019.00730]
[27]
Björnsson, E.; Olsson, R. Outcome and prognostic markers in severe drug-induced liver disease. Hepatology, 2005, 42(2), 481-489.
[http://dx.doi.org/10.1002/hep.20800] [PMID: 16025496]
[http://dx.doi.org/10.1002/hep.20800] [PMID: 16025496]
[28]
Björnsson, E.S.; Bergmann, O.M.; Björnsson, H.K.; Kvaran, R.B.; Olafsson, S. Incidence, presentation, and outcomes in patients with drug-induced liver injury in the general population of Iceland. Gastroenterology, 2013, 144(7), 1419-1425.
[http://dx.doi.org/10.1053/j.gastro.2013.02.006] [PMID: 23419359]
[http://dx.doi.org/10.1053/j.gastro.2013.02.006] [PMID: 23419359]
[29]
Hoofnagle, J.H.; Navarro, V.J. Drug-induced liver injury: Icelandic lessons. Gastroenterology, 2013, 144(7), 1335-1336.
[http://dx.doi.org/10.1053/j.gastro.2013.04.026] [PMID: 23623967]
[http://dx.doi.org/10.1053/j.gastro.2013.04.026] [PMID: 23623967]
[30]
Björnsson, E.; Jacobsen, E.I.; Kalaitzakis, E. Hepatotoxicity associated with statins: reports of idiosyncratic liver injury post-marketing. J. Hepatol., 2012, 56(2), 374-380.
[http://dx.doi.org/10.1016/j.jhep.2011.07.023] [PMID: 21889469]
[http://dx.doi.org/10.1016/j.jhep.2011.07.023] [PMID: 21889469]
[31]
Bader, T. Yes! Statins can be given to liver patients. J. Hepatol., 2012, 56(2), 305-307.
[http://dx.doi.org/10.1016/j.jhep.2011.08.016] [PMID: 21963520]
[http://dx.doi.org/10.1016/j.jhep.2011.08.016] [PMID: 21963520]
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