Hepatotoxicidad secundaria a "productos naturales": análisis de los casos notificados al Registro Español de Hepatotoxicidad

García‐Cortés, Miren; Borraz, Y.; Lucena, M. Isabel; Peláez, Gloria Isabel Carvajal; Salmerón, J F Martínez; Diago, M.; Martínez-Sierra, M. Carmen; Navarro, José María; Planas, Ramón; Soria, M. J.; Bruguera, Miquel; Andrade, Raúl J.

doi:10.4321/s1130-01082008001100004

Cited by 62 publications

(39 citation statements)

References 71 publications

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“…Subjective judgement is needed for many steps, making this method more prone to bias [87] . Though commonly applied by the Spanish Pharmacovigilance Centres [74] , the KL method is not used by the Spanish Group for the Study of Druginduced Liver Disease [59,85,87,95] , which applies the CIOMS scale as the preferred assessment tool. The KL method should not be used for assessment of hepatotoxicity cases.…”

Section: Kl Methodsmentioning

confidence: 99%

“…Regarding risk factor of alcohol use, 1 drink commonly contains about 10 g ethanol [2,3,90] . Total score and resulting causality grad- ity assessment in hepatotoxicity cases [1][2][3][4]13,14,17,[21][22][23][24][25][26][34][35][36][37][38][39][59][60][61][62][63][64] . HILI case series reported in 23 publications with 573 HILI cases used various causality assessment methods [12][13][14]23,25,[34][35][36]38,39,53,54,[65][66][67][68][69][70][71][72][73][74][75] .…”

Section: Methods Categoriesmentioning

confidence: 99%

“…For reexposure assessments of the cholestatic (± hepatocellular) type of liver injury, ALT has to be replaced by ALP. Criteria for positive reexposure tests are included in the updated CIOMS scale (Tables 5 and 6) and were not previously applied in cases with reported positive reexposure tests [40][41][42][43][44][45][46][47][48][49][50][51][52][53][54][55][56][57]59,91] . When these cases were submitted to retrospective analysis using the reexposure test criteria, a positive reexposure test could be confirmed in only 13/30 cases, the test was negative in 5/30 cases and uninterpretable in 12/30 cases [91] .…”

Section: Cioms Scalementioning

confidence: 99%

“…In 8 cases of initially assumed Herbalife hepatotoxicity with a previously reported positive reexposure test result, retrospective evaluation applying the test criteria revealed that criteria for a positive reexposure were fulfilled in only 1/8 cases, whereas the reexposure test was classified as negative in another case or the data were considered as uninterpretable due to missing information to comply adequately with the criteria in the remaining six cases [94] . The CIOMS scale was widely used for hepatotoxicity assessments in epidemiological studies, clinical trials, case reports, case series, regulatory analyses, and genotyping studies [13,14,24,25,35,36,38,39,58,59,61,64,72,79,84,86,87,90,[95][96][97][98] . Proposals for refinement and strengthening of the CIOMS scale focused on the weight of individual parameters and risk factors such as alcohol and age, and other shortcomings were addressed [24,87,89,90,98] .…”

Section: Cioms Scalementioning

confidence: 99%

“…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%

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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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Section: Kl Methodsmentioning

confidence: 99%

Section: Methods Categoriesmentioning

confidence: 99%

Section: Cioms Scalementioning

confidence: 99%

Section: Cioms Scalementioning

confidence: 99%

Section: Expert Opinionmentioning

confidence: 99%

See 3 more Smart Citations

Herbal hepatotoxicity: Challenges and pitfalls of causality assessment methods

Teschke¹,

Frenzel²,

Schulze³

et al. 2013

WJG

156

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Estimated Exposure to 6 Potentially Hepatotoxic Botanicals in US Adults

Likhitsup,

Chen,

Fontana

2024

JAMA Netw Open

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ImportanceUse of herbal and dietary supplements (HDSs) accounts for an increasing proportion of drug hepatotoxicity cases. Turmeric or curcumin, green tea extract, Garcinia cambogia, black cohosh, red yeast rice, and ashwagandha are the most frequently reported hepatoxic botanicals, but their prevalence and reasons for use in the general population are unknown.ObjectiveTo assess the prevalence and clinical characteristics of adult consumers of 6 potentially hepatoxic botanicals.Design, Setting, and ParticipantsThis survey study analyzed nationally representative data from the National Health and Nutrition Examination Survey (NHANES), a nationally representative, cross-sectional survey of the general US population. Prescription drug and HDS exposure data in the past 30 days were analyzed, and 2020 US Census data were used for population estimates. Data were analyzed July 1, 2023, to February 1, 2024.ExposuresAdult NHANES participants enrolled between January 2017 and March 2020.Main Outcomes and MeasuresBaseline weighted characteristics of HDS users and users of 6 potentially hepatotoxic botanical products were compared with non–HDS users. Multivariable analysis was undertaken to identify factors associated with HDS use or at-risk botanical use.ResultsAmong 9685 adults enrolled in this NHANES cohort, the mean (SE) age was 47.5 (0.5) years, and 51.8% (95% CI, 50.2%-53.4%) were female. The overall prevalence of HDS product use was 57.6% (95% CI, 55.9%-59.4%), while the prevalence of using the 6 botanicals of interest was 4.7% (95% CI, 3.9%-5.7%). Turmeric-containing botanicals were most commonly used (n = 236), followed by products containing green tea (n = 92), ashwagandha (n = 28), Garcinia cambogia (n = 20), red yeast rice (n = 20), and black cohosh (n = 19). Consumers of these 6 botanicals were significantly older (adjusted odds ratio [AOR], 2.36 [95% CI, 1.06-5.25]; P = .04 for 40-59 years of age and AOR, 3.96 [95% CI, 1.93-8.11]; P = .001 for ≥60 years of age), had a higher educational level (AOR, 4.78 [95% CI, 2.62-8.75]; P &lt; .001), and were more likely to have arthritis (AOR, 2.27 [95% CI, 1.62-3.29]; P &lt; .001) compared with non–HDS users. An estimated 15 584 599 (95% CI, 13 047 571-18 648 801) US adults used at least 1 of the 6 botanical products within the past 30 days, which was similar to the estimated number of patients prescribed potentially hepatotoxic drugs, including simvastatin (14 036 024 [95% CI, 11 202 460-17 594 452]) and nonsteroidal anti-inflammatory drugs (14 793 837 [95% CI, 13 014 623-16 671 897]). The most common reason for consuming turmeric and green tea was to improve or maintain health.Conclusions and RelevanceIn this survey study, an estimated 15.6 million US adults consumed at least 1 botanical product with liver liability within the past 30 days, comparable with the number of people who consumed nonsteroidal anti-inflammatory drugs and a commonly prescribed hypolipidemic drug. Given a lack of regulatory oversight on the manufacturing and testing of botanical products, clinicians should be aware of possible adverse events from consumption of these largely unregulated products.

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Drug-Induced Liver Injury in Children: A Structured Approach to Diagnosis and Management

López

Bilhartz

2013

Diseases of the Liver in Children

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Hepatotoxicidad secundaria a "productos naturales": análisis de los casos notificados al Registro Español de Hepatotoxicidad

Cited by 62 publications

References 71 publications

Herbal hepatotoxicity: Challenges and pitfalls of causality assessment methods

Herbal hepatotoxicity: Challenges and pitfalls of causality assessment methods

Estimated Exposure to 6 Potentially Hepatotoxic Botanicals in US Adults

Drug-Induced Liver Injury in Children: A Structured Approach to Diagnosis and Management

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