Recent status of drug‐induced liver injury

Takikawa, Hajime

doi:10.1111/j.1872-034x.2008.00400.x

Cited by 46 publications

(46 citation statements)

References 58 publications

(123 reference statements)

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“…The incidence of this condition is currently increasing in parallel with the increase in the number of new drugs available on the market (1). In addition to prescription medications, dietary supplements and/or over-the-counter (OTC) drugs can induce liver injury to a greater extent than previously thought.…”

Section: Introductionmentioning

confidence: 94%

Drug-induced Liver Injury with Serious Multiform Exudative Erythema following the Use of an Over-the-counter Medication Containing Ibuprofen

et al. 2015

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A 36-year-old Japanese woman took over-the-counter (OTC) medication for headaches for 20 days. Subsequently, five days after discontinuing the medication, a skin rash developed over the patient's upper and lower limbs and face, in addition to a fever, brown urine and serious liver dysfunction. Drug lymphocyte stimulation tests implicated ibuprofen, a main component of the OTC drugs, which has the potential to induce this pathology, and a diagnosis of drug-induced liver injury with multiform exudative erythema was made. The patient's symptoms and liver function tests returned to normal following treatment with systemic steroids.

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Section: Introductionmentioning

confidence: 94%

Drug-induced Liver Injury with Serious Multiform Exudative Erythema following the Use of an Over-the-counter Medication Containing Ibuprofen

et al. 2015

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“…considered [5,10,14,24,28,29,44,45,76] . Limited access and lack of standardization have prevented general clinical use of the DLST and consequently TTK scale applications outside Japan [29] ; this may be due to methodological difficulties with false positive and false negative cases in the DLST [25,75] . For clinicians, the TTK scale cannot replace the CIOMS scale [25] .…”

Section: Other Liver Specific Methodsmentioning

confidence: 99%

“…The MV scale is not commonly recommended for assessing causality in assumed DILI and HILI cases and is certainly no substitute for the CIOMS scale [24] . The TTK scale [25] , named for the first three authors Takikawa, Takamori, Kumagi et al [74] , is a modification of the CIOMS scale [21] with different evaluations of the chronology, exclusion of comedication, inclusion of the drug lymphocyte stimulation test (DLST) and of eosinophilia in their assessment system [74,75] . The TTK scale is widely used in Japan [74] , as recently reviewed [75] .…”

Section: Other Liver Specific Methodsmentioning

confidence: 99%

“…The TTK scale [25] , named for the first three authors Takikawa, Takamori, Kumagi et al [74] , is a modification of the CIOMS scale [21] with different evaluations of the chronology, exclusion of comedication, inclusion of the drug lymphocyte stimulation test (DLST) and of eosinophilia in their assessment system [74,75] . The TTK scale is widely used in Japan [74] , as recently reviewed [75] . In other countries, this scale is not or rarely [59] Kava 20 Teschke et al [60] Kava 36 Stickel et al [61] Kava 80 Schmidt et al [62] Greater Celandine 23 BfArM [63] Black cohosh 31 EMA [54] Herbalife products 12 Elinav et al [64] Herbalife products 12 Schoepfer et al [65] Kava 26 Teschke et al [12] Black cohosh 30 Mahady et al [42] Green tea 34 Sarma et al [43] Black cohosh 4 Teschke et al [47] Black cohosh 9 Teschke et al [48] Kava 31 Teschke [34] Hydroxycut 17 Fong et al [66] Black cohosh 22 Teschke et al [36] Greater Celandine 22 Teschke et al [37] Herbalife products 20 Manso et al [67] Various herbs 45 Chau et al [57] Greater Celandine 21 Teschke et al [32] Pelargonium sidoides 15 Teschke et al [38] Pelargonium sidoides 13 Teschke et al [39] Sum ( The data are derived from a study evaluating alternative causes in suspected HILI cases (n = 573) comprising the study cohort [5] .…”

Section: Other Liver Specific Methodsmentioning

confidence: 99%

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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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“…For DILI, groups of skilled hepatologists exists without any doubt in most countries including Japan [108,109] and in expert projects like the international DILI Expert Working Group [90] , the United States DILIN group [73,80,86,102,103] , the Spanish Group for the Study of Drug-Induced Liver Disease [59,85,87,95,101] , and the Spanish-Latin American network on drug induced liver injury [110] . For HILI, the Hong Kong Herb-Induced Liver Injury Network is of importance [75] .…”

Section: Expert Opinionmentioning

confidence: 99%

Herbal hepatotoxicity: Challenges and pitfalls of causality assessment methods

Teschke¹,

Frenzel²,

Schulze³

et al. 2013

WJG

156

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totoxicity cases, compared to numerous other causality assessment methods, which are inferior on various grounds. Among these disputed methods are the Maria and Victorino scale, an insufficiently qualified, shortened version of the CIOMS scale, as well as various liver unspecific methods such as the ad hoc causality approach, the Naranjo scale, the World Health Organization (WHO) method, and the Karch and Lasagna method. An expert panel is required for the Drug Induced Liver Injury Network method, the WHO method, and other approaches based on expert opinion, which provide retrospective analyses with a long delay and thereby prevent a timely assessment of the illness in question by the physician. In conclusion, HILI causality assessment is challenging and is best achieved by the liver specific CIOMS scale, avoiding pitfalls commonly observed with other approaches.© 2013 Baishideng. All rights reserved.Key words: Herbal hepatotoxicity; Herb induced liver injury; Herbs; Drug hepatotoxicity; Drug induced liver injury; Causality assessment Core tip: This review focuses on diagnostic causality assessment algorithms that have been used so far in herb induced liver injury (HILI) cases. Detailed information of the various methods with their strengths and weaknesses is provided including their challenges and pitfalls that emerged during the assessing course. For the physician caring for a patient with suspected HILI, the Council for International Organizations of Medical Sciences (CIOMS) scale is the preferred tool for assessing causality compared to numerous other causality assessment methods, which are inferior on various grounds. CIOMS based assessment should start at the day HILI is suspected to ensure completeness of clinical data. AbstractThe diagnosis of herbal hepatotoxicity or herb induced liver injury (HILI) represents a particular clinical and regulatory challenge with major pitfalls for the causality evaluation. At the day HILI is suspected in a patient, physicians should start assessing the quality of the used herbal product, optimizing the clinical data for completeness, and applying the Council for International Organizations of Medical Sciences (CIOMS) scale for initial causality assessment. This scale is structured, quantitative, liver specific, and validated for hepatotoxicity cases. Its items provide individual scores, which together yield causality levels of highly probable, probable, possible, unlikely, and excluded. After completion by additional information including raw data, this scale with all items should be reported to regulatory agencies and manufacturers for further evaluation. The CIOMS scale is preferred as tool for assessing causality in hepa-

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Recent status of drug‐induced liver injury

Cited by 46 publications

References 58 publications

Drug-induced Liver Injury with Serious Multiform Exudative Erythema following the Use of an Over-the-counter Medication Containing Ibuprofen

Drug-induced Liver Injury with Serious Multiform Exudative Erythema following the Use of an Over-the-counter Medication Containing Ibuprofen

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

Herbal hepatotoxicity: Challenges and pitfalls of causality assessment methods

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