Severe hepatotoxicity following ingestion of Herbalife® nutritional supplements contaminated with Bacillus subtilis

Stickel, Felix; Droz, Sara; Patsenker, E.; Bögli-Stuber, Katja; Aebi, Beat; Leib, Stephen L.

doi:10.1016/j.jhep.2008.08.017

Cited by 107 publications

(94 citation statements)

References 41 publications

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“…They also stressed the importance of health professionals being aware that not all of these products (plant-based food supplements) are safe, that cases of severe hepatotoxicity after their consumption have been reported, and that diagnosis and causality assessment in these cases are extremely difficult (Chao et al, 2008). Stickel et al (2009) Both patients, a man (78 years old) and a woman (50 years old), presented with cholestatic hepatitis and high levels of hepatic enzymes. The man reported the consumption of alcohol as well as prescription medication while medical exams revealed an underlying disease.…”

Section: Resultsmentioning

confidence: 99%

“…The authors also warned of the need for regulatory measures applying stricter control over food supplements, and of the need to increase awareness amongst consumers and health professionals regarding the potential for health damage caused by the use of food supplements (Stickel et al, 2009). Chen et al (2010) described three cases of liver injury induced by weight-loss herbal supplements reported in the United States of America, with two cases involving Herbalife ® products.…”

Section: Resultsmentioning

confidence: 99%

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A critical analysis of the hepatotoxicity cases described in the literature related to Herbalife (r) products

Zambrone¹,

Corrêa²,

Amaral³

2015

Braz. J. Pharm. Sci.

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The aim of this study was to assess the hepatotoxicity cases described in the literature, attributed to the consumption of Herbalife ® products, and to determine whether a causal relationship exists between the reported cases of liver injury and the use of these products. A literature search was performed on the PubMed, LILACS and PAHO databases. Seven publications reporting a total of 53 cases of hepatotoxicity linked to the use of Herbalife ® products were retrieved. All of the studies lacked sufficient information to some degree, whether related to patients' history, concomitant use of medication and/or other compounds (including alcohol), observations on interrupted use (dechallenge), results found with markers, viral serology and autoantibodies or observations concerning re-exposure to the products. In addition to these items, the lack of clear information on the type of products evaluated and their respective composition is an important factor to be considered. Furthermore, data quality was also questionable due to the presence of confounding factors, absence of proper exclusion of alternative explanations, and the use of questionable methods for attributing causality. Hence, an association between hepatotoxicity and consumption of these products cannot be proven based on the data collected and rigorous scientific analysis.Uniterms: Hepatotoxicity. Herbalife ® . Herbalife products ®/ consumption/hepatotoxicity. Dietary supplements. Causality assessment.Este estudo teve como objetivo avaliar os casos de hepatotoxicidade descritos em literatura, atribuídos ao consumo de produtos Herbalife ® , e verificar se é possível ou não estabelecer uma relação de causalidade entre eles. Realizou-se levantamento bibliográfico nas bases de dados PubMed, LILACS e PAHO e foram encontrados 7 manuscritos reportando 53 casos de hepatotoxicidade, relacionados ao uso de produtos Herbalife. Observou-se que todos trazem, de alguma forma, quantidade insuficiente de informações em relação ao histórico dos pacientes, ao uso concomitante de medicamentos e/ou outros compostos (incluindo álcool), às observações após a interrupção do uso (dechallenge), aos resultados referentes a marcadores e sorologia virais e autoanticorpos e às observações quanto à reexposição aos produtos. Some-se a estes fatos a falta de identificação clara e comprovada do tipo de produto envolvido, assim como sua composição. Além disso, a qualidade dos dados também é questionável devido à presença de variáveis de confundimento, ausência de exclusão adequada de explicações alternativas e ao uso de métodos discutíveis de atribuição de causalidade. Desta forma, a associação entre hepatotoxicidade e o consumo destes produtos não pode ser comprovada, após observar o conjunto dos dados coletados, utilizando-se rigor técnico-cientifico.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

A critical analysis of the hepatotoxicity cases described in the literature related to Herbalife (r) products

Zambrone¹,

Corrêa²,

Amaral³

2015

Braz. J. Pharm. Sci.

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“…Considerable interest focused on the question whether few Herbalife products are potentially hepatotoxic like some other herbal products and dietary supplements [1][2][3][4][5][6][7][8][9][10] . These reports created safety concerns and led to editorials [11][12][13] , commentaries [14][15][16] , and critical Letters to the Editor [17][18][19][20][21][22][23][24][25][26][27] , all addressing relevant issues [11][12][13][14][15][16][17][18][19][20][21][22][23][24][25][26][27] .…”

Section: Introductionmentioning

confidence: 99%

“…These reports created safety concerns and led to editorials [11][12][13] , commentaries [14][15][16] , and critical Letters to the Editor [17][18][19][20][21][22][23][24][25][26][27] , all addressing relevant issues [11][12][13][14][15][16][17][18][19][20][21][22][23][24][25][26][27] . Speculations about bacterial contamination with Bacillus subtilis in Herbalife products emerged [8,12] , and potentially hepatotoxic ingredients such as green tea extracts, ephedra sinica, aloe, or vitamin A overdose have been proposed as culprits [2][3][4]10] . In addition, overall case data quality was mixed due to confounding variables, missing firm exclusion of alternative explanations, and the use of problematic causality attribution methods [1][2][3][4][5][6][7]…”

Section: Introductionmentioning

confidence: 99%

“…Speculations about bacterial contamination with Bacillus subtilis in Herbalife products emerged [8,12] , and potentially hepatotoxic ingredients such as green tea extracts, ephedra sinica, aloe, or vitamin A overdose have been proposed as culprits [2][3][4]10] . In addition, overall case data quality was mixed due to confounding variables, missing firm exclusion of alternative explanations, and the use of problematic causality attribution methods [1][2][3][4][5][6][7][8][9][10] . For hepatotoxicity cases, even with stringent causality assessment the culprits remain undetected in up to 38% of severe liver disease [28] , and alternative causes are frequently found [16,29,30] , with up to 47% in initially assumed drug induced liver injury (DILI) cases [16,29] and with an average of 49% in initially suspected herb induced liver injury (HILI) cases [30] .…”

Section: Introductionmentioning

confidence: 99%

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Herbalife hepatotoxicity: Evaluation of cases with positive reexposure tests

Teschke¹,

Frenzel²,

Schulze³

et al. 2013

WJH

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AIM:To analyze the validity of applied test criteria and causality assessment methods in assumed Herbalife hepatotoxicity with positive reexposure tests. METHODS:We searched the Medline database for suspected cases of Herbalife hepatotoxicity and retrieved 53 cases including eight cases with a positive unintentional reexposure and a high causality level for Herbalife. First, analysis of these eight cases focused on the data quality of the positive reexposure cases, requiring a baseline value of alanine aminotransferase (ALT) < 5 upper limit of normal (N) before reexposure, with N as the upper limit of normal, and a doubling of the ALT value at reexposure as compared to the ALT value at baseline prior to reexposure. Second, reported methods to assess causality in the eight cases were evaluated, and then the liver specific Council for International Organizations of Medical Sciences (CIOMS) scale validated for hepatotoxicity cases was used for quantitative causality reevaluation. This scale consists of various specific elements with scores provided through the respective case data, and the sum of the scores yields a causality grading for each individual case of initially suspected hepatotoxicity. RESULTS:Details of positive reexposure test conditions and their individual results were scattered in virtually all cases, since reexposures were unintentional and allowed only retrospective rather than prospective assessments. In 1/8 cases, criteria for a positive reexposure were fulfilled, whereas in the remaining cases the reexposure test was classified as negative (n = 1), or the data were considered as uninterpretable due to missing information to comply adequately with the criteria (n = 6). In virtually all assessed cases, liver unspecific causality assessment methods were applied rather than a liver specific method such as the CIOMS scale. Using this scale, causality gradings for Herbalife in these eight cases were probable (n = 1), unlikely (n = 4), and excluded (n = 3). Confounding variables included low data quality, alternative diagnoses, poor exclusion of important other causes, and comedication by drugs and herbs in 6/8 cases. More specifically, problems were evident in some cases regarding temporal association, daily doses, exact start and end dates of product use, actual data of laboratory parameters such as ALT, and exact dechallenge characteristics. Shortcomings included scattered exclusion of hepatitis A-C, cytomegalovirus and Epstein Barr virus infection with only globally presented or lacking parameters. Hepatitis E virus infection was considered in one single patient and found positive, infections by herpes simplex ORIGINAL ARTICLE

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Liver injury from herbals and dietary supplements in the U.S. Drug-Induced Liver Injury Network

et al. 2014

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Background The Drug-Induced Liver Injury Network (DILIN) studies hepatotoxicity due to conventional medications as well as herbals and dietary supplements (HDS). Rationale To characterize hepatotoxicity and its outcomes from HDS versus medications, patients with hepatotoxicity attributed to medications or HDS were enrolled prospectively between 2004 and 2013. The study took place among eight US referral centers that are part of the DILIN. Consecutive patients with liver injury referred to a DILIN center were eligible. The final sample comprised 130 (15.5%) of all subjects enrolled (839) who were judged to have experienced liver injury due to HDS. Hepatotoxicity due to HDS was evaluated by expert opinion. Demographic and clinical characteristics and outcome assessments including death and liver transplantation were ascertained. Cases were stratified and compared according to the type of agent implicated in liver injury; 45 had injury due to bodybuilding HDS, 85 due to non-bodybuilding HDS, and 709 due to medications. Main Results Liver injury due to HDS increased from 7% to 20% (p < 0.001) during the study period. Bodybuilding HDS caused prolonged jaundice (median 91 days) in young men but did not result in any fatalities or liver transplantation. The remaining HDS cases presented as hepatocellular injury, predominantly in middle-aged women and more frequently led to death or transplantation compared to injury from medications (13% vs. 3%, p < 0.05). Conclusions The proportion of liver injury cases attributed to HDS in DILIN has increased significantly. Liver injury from non-bodybuilding HDS is more severe than from bodybuilding HDS or medications, as evidenced by differences in unfavorable outcomes; death and transplantation.

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Severe hepatotoxicity following ingestion of Herbalife® nutritional supplements contaminated with Bacillus subtilis

Cited by 107 publications

References 41 publications

A critical analysis of the hepatotoxicity cases described in the literature related to Herbalife (r) products

A critical analysis of the hepatotoxicity cases described in the literature related to Herbalife (r) products

Herbalife hepatotoxicity: Evaluation of cases with positive reexposure tests

Liver injury from herbals and dietary supplements in the U.S. Drug-Induced Liver Injury Network

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