Causality assessment of adverse drug reactions: comparison of the results obtained from published decisional algorithms and from the evaluations of an expert panel, according to different levels of imputability

Macedo, Ana; Marques, Francisco Batel; Ribeiro, Carlos Fontes; Teixeira, Frederico

doi:10.1046/j.1365-2710.2003.00475.x

Cited by 78 publications

(48 citation statements)

References 22 publications

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“…102 Most emphasis, however, has been placed on adjudication by an expert panel. 103 Because there is no consensus on the preferred diagnostic approach, the DILIN investigators are presently working to develop an improved approach to causality assessment. A complex computerbased process is utilized in gathering and distributing relevant information.…”

Section: Leonard B Seeff: Improving Causality Assessmentmentioning

confidence: 99%

Drug-induced liver injury: Summary of a single topic clinical research conference

2006

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Section: Leonard B Seeff: Improving Causality Assessmentmentioning

confidence: 99%

Drug-induced liver injury: Summary of a single topic clinical research conference

2006

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“…In contrast to the liver specific core elements of the original and updated CIOMS scale (Tables 1 and 2) [4, [21][22][23][24] , numerous causality algorithms are liver unspecific [4,24,76,79,80] , including the Naranjo scale [81] , the World Health Organization (WHO) global introspection method as the WHO method in short [82] , and the KL method of Karg and Lasagna [83] . Particularly intensive discussions focused on the Naranjo scale [4,24,25,[84][85][86][87] , the WHO method [4,24,84,87] , and the KL method [24,25] .…”

Section: Liver Unspecific Methodsmentioning

confidence: 99%

Drug and herb induced liver injury: Council for International Organizations of Medical Sciences scale for causality assessment

Teschke

Wolff

Frenzel

et al. 2014

WJH

109

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Causality assessment of suspected drug induced liver injury (�ILI) and herb induced liver injury (HILI) is hampered by the lack of a standardized approach to be used by attending physicians and at various subsequent evaluating levels. The aim of this review was to analyze the suitability of the liver specific Council for International Organizations of �edical Sciences (CIO�S) scale as a standard tool for causality assessment in �ILI and HILI cases. �ub�ed database was searched for the following terms: drug induced liver injury; herb induced liver injury; �ILI causality assessment; and HILI causality assessment. The strength of the CIO�S lies in its potential as a standardized scale for �ILI and HILI causality assessment. Other advantages include its liver specificity and its validation for hepatotoxicity with excellent sensitivity, specificity and predictive validity, based on cases with a positive reexposure test. This scale allows prospective collection of all relevant data required for a valid causality assessment. It does not require expert knowledge in hepatotoxicity and its results may subsequently be refined. Weaknesses of the CIO�S scale include the limited exclusion of alternative causes and qualitatively graded risk factors. In conclusion, CIO�S appears to be suitable as a standard scale for attending physicians, regulatory agencies, expert panels and other scientists to provide a standardized, reproducible causality assessment in suspected �ILI and HILI cases, applicable primarily at all assessing levels involved.© 2014 Baishideng �ublishing Group Co., Limited. All rights reserved.Key words: �rug induced liver injury; �rug hepatotoxicity; Herb induced liver injury; Herbal hepatotoxicity; Causality assessment Core tip: We propose that the attending physicians caring for patients with assumed drug induced liver injury and herb induced liver injury should use the Council for International Organizations of �edical Sciences (CIO�S) scale for causality assessment. This approach includes the option of subsequent refinement of the CIO�S based results by expert panels and regulatory agencies. The use of the CIO�S scale as an identical

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“…Despite the associations between orlistat and AKI, establishing causality between drug exposure and adverse outcome is challenging [Macedo et al 2003;Meyboom, 1998;Karch et al 1976]. Although innumerable algorithms and probabilistic models have been developed to improve upon the common practice of assigning causality based on expert opinion, no gold standard exists [Agbabiaka et al 2008].…”

Section: Causalitymentioning

confidence: 99%

Does orlistat cause acute kidney injury?

Beyea¹,

Garg²,

Weir³

2011

Therapeutic Advances in Drug Safety

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Abstract:Orlistat is an inhibitor of gastric and pancreatic lipase with proven efficacy in the augmentation and maintenance of weight loss. Although its use has been limited by troublesome but benign gastrointestinal side effects, it has more recently been associated with acute kidney injury (AKI). In this review, we summarize orlistat's benefits and drawbacks and discuss the body of evidence supporting its role as a cause of AKI. Although we cannot yet draw an unequivocal causal link between orlistat and AKI, there is enough evidence to include orlistat exposure in the clinical assessment of patients with AKI.

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Causality assessment of adverse drug reactions: comparison of the results obtained from published decisional algorithms and from the evaluations of an expert panel, according to different levels of imputability

Abstract: Full agreement with global introspection was not found for any level of causality assessment. Confounding variables were found to be associated with low levels of agreement between decision algorithms and the GI method compromising the algorithms' sensitivity and specificity.

Cited by 78 publications

References 22 publications

Drug-induced liver injury: Summary of a single topic clinical research conference

Drug-induced liver injury: Summary of a single topic clinical research conference

Drug and herb induced liver injury: Council for International Organizations of Medical Sciences scale for causality assessment

Does orlistat cause acute kidney injury?

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