A critical analysis of the hepatotoxicity cases described in the literature related to Herbalife® products

Brazilian Journal of Pharmaceutical Sciences

Volumn 51, Issue 4, 2015, Pages 785-796

  Zambrone, Flávio Ailton Duque ^a   Corrêa, Cristiana Leslie ^a   do Amaral, Ligia Mesquita Sampaio ^a  

^a Planitox The Science based Toxicology Company   (Brazil)

Author keywords

Causality assessment; Dietary supplements; Hepatotoxicity; Herbalife products consumption hepatotoxicity; Herbalife

Indexed keywords

AUTOANTIBODY; HERBACEOUS AGENT;

ARTICLE; DRUG REEXPOSURE; DRUG USE; FULMINANT HEPATIC FAILURE; HUMAN; LIVER INJURY; LIVER TOXICITY; MEDICAL HISTORY; QUESTIONNAIRE; SEROLOGY; TOXIC HEPATITIS; WORLD HEALTH ORGANIZATION;

EID: 84962749823     PISSN: 19848250     EISSN: 21759790     Source Type: Journal    
DOI: 10.1590/S1984-82502015000400004     Document Type: Article

References (41)

1. ABDEL-RAHMAN, A.; ANYANGWE, N.; CARLACCI, L.; CASPER, S.; DANAM, R., ENONGERE, E.; ERIVES, G., FABRICANT, D.; GUDI, R.; HILMAS, C.; HINES, F.; HOWARD, P.; LEVY, D.; LIN, Y.; MOORE, R.J.; PFEILER, E.; THURMOND, T.; TURUJMAN, S.; WALKER, N. The safety and regulatory of natural products used as food and food ingredients. Toxicol. Sci., v.123, n.2, p.333-348, 2011.
2. APPELHANS K., FRANKOS V., SHAO A. Misconceptions regarding the association between Herbalife products and liver-related case reports in Spain. Pharmacoepidemiol. Drug Saf., v.21, n.3, p.333-334, 2012.
3. APPELHANS, K.; SMITH, C; BEJAR, E; HENIG, Y.S. Revisiting acute liver injury associated with herbalife products. World J. Hepatol., v.3, n.10, p.275-277, 2011.
4. APPELHANS K., GOLDSTEIN, L. Revisiting liver injury associated with dietary supplements. Liver Int., v.31, n.8, p.1239-1241, 2011.
5. APPELHANS K., FRANKOS V. Herbal medicine hepatotoxicity revisited. J. Hepatol. v.56, n.2, p.504-505, 2012.
6. APPELHANS, K.; NAJEEULLAH, R; FRANKOS, V. Letter: a correction of misinformation regarding Herbalife. World J. Hepatol., v.5, n.10, p.601-602, 2013a.
7. APPELHANS, K., NAJEEULLAH, R., FRANKOS, V. Letter: retrospective reviews of liver-related case reports allegedly associated with Herbalife present insufficient and inaccurate data. Aliment. Pharmacol. Ther., v.37, n.7, p.73-74, 2013b.
8. APPELHANS, K., NAJEEULLAH, R., FRANKOS, V. Considerations regarding the alleged association between Herbalife products and cases of hepatotoxicity. Intern. Emerg. Med., v.9, n.5, p.599-600, 2014a.
9. APPELHANS, K., NAJEEULLAH, R., FRANKOS, V., SHAO, A. Outdated perspectives potentially biased conclusory statements regarding Herbalife products. J. Appl. Pharm., Sci., v.4, n.2, p.133-134, 2014b.
10. BEJAR E, SMITH CR, APPELHANS K, HENIG YS. Correcting a misrepresentation of hypervitaminosis A attributed to Herbalife product consumption. Exp. Mol. Pathol.; v.90, n.3, p.320-321, 2011.
11. BUNCHORNTAVAKUL, C.; REDDY, K.R. Review article: herbal and dietary supplement hepatotoxicity. Aliment. Pharm. Ther., v.37, n.1, p.3-17, 2013.
12. CHAO, S.; ANDERS, M.; TURBAY, M.; OLAIZ, E.; CORMACK, L.; MASTAI, R. Hepatitis aguda asociada al consumo de Herbalife® a propósito de un caso. Acta Gastroenterol. Latinoam., v.38, n.4, p.274-277, 2008.
13. CHEN, G.C.; RAMANATHAN, V.S.; LAW, D.; FUNCHAIN, P.; CHEN, G.C.; FRENCH, S.; SHLOPOV, B.; EYSSELEIN, V.; CHUNG, D.; REICHER, S.; PHAM, B.V. Acute liver injury induced by weight-loss herbal supplements. World J. Hepatol., v.2, n.11, p.410-415, 2010.
14. COPPENS, P.; DELMULLE, L.; GULATI, O.; RICHARDSON, D; RUTHSATZ, M.; SIEVERS, H.; SIDANI, S.; EUROPEAN BOTANICAL FORUM. Use of botanicals in food supplements. Ann. Nutr. Metab., v.50, p.538-554, 2006.
15. ELINAV, E.; PINSKER, G.; SAFADI, R.; PAPPO, O.; BROMBERG, M.; ANIS, E.; KEINAN-BOKER, L.; BROIDE, E.; ACKERMAN, Z.,KALUSKU, D.; LEV, B.; SHOUVAL, D. Association between consumption of Herbalife® nutritional supplements and acute hepatotoxicity. J. Hepatol., v.47, n.4, p.514-520, 2007.
16. EUROPEAN COMMISSION. EC. Technical guidance document on risk assessment: Part I. European Communities: [S.n.], 2003.
17. FENKEL, J.M.; NAVARRO, V.J. Review: herbal and dietary supplement-induced liver injury. Gastroenterol. Hepatol., v.7, n.10, p.695-696, 2011.
18. IGNARRO, L., HEBER, D., HENIG, Y.S. Herbalife nutritional products and liver injury revisited. J. Hepatol., v.49, n.2, p.291-293, 2008.
19. INTERNATIONAL LIFE SCIENCES INSTITUTE. ILSI. Guidance for the safety assessment of botanicals and botanicals preparations for use in food and food supplements. Brussels,: ILSI Europe, 2003. 47 p.
20. INTERNATIONAL PROGRAMME ON CHEMICAL SAFETY. IPCS. Environmental health criteria 170: assessing human health risks of chemicals: derivation of guidance values for health-based exposure limits. Geneva, Switzerland: World Health Organization, 1994. Available at: . Accessed on: 11 Sep. 2014.
21. INTERNATIONAL PROGRAMME ON CHEMICAL SAFETY. IPCS. Environmental health criteria 210: principles for the assessment of risks to human health from exposure to chemicals. Geneva, Switzerland: World Health Organization, 1999. Available at: . Accessed on: 11 Sep. 2014.
22. INTERNATIONAL PROGRAMME ON CHEMICAL SAFETY. IPCS. IPCS risk assessment terminology. Geneva, Switzerland: World Health Organization, 2004. Harmonization Project Document no.1. Available at: . Accessed on: 11 Sep. 2014.
23. INTERNATIONAL PROGRAMME ON CHEMICAL SAFETY. IPCS. Training module no.4: general scientific principles of chemical safety. Geneva, Switzerland: World Health Organization, 2000. Available at: . Accessed on: 11 Sep. 2014.
24. INTERNATIONAL PROGRAMME ON CHEMICAL SAFETY. IPCS. WHO human health risk assessment toolkit: chemical hazards. Geneva, Switzerland: World Health Organization, 2010. (Harmonization Project Document n.8). Available at: . Accessed on: 11 Sep. 2014.
25. JÓHANNSSON, M.; ORMARSDÓTTIR, S; OLAFSSON, S. Hepatotoxicity associated with the use of Herbalife. Laeknabladid, v.96, n.3, p.167-172, 2010. [Abstract].
26. KROES, R.; WALKER. R. Safety issues of botanicals and botanical preparations in functional foods. Toxicology, v.198, n.1-3, p.213-220, 2004.
27. MANSO, G.; LOPEZ-RIVAS, L.; SALGUEIRO, M; DUQUE J.; JIMENO, F.; ANDRADE R., LUCENA, M. Continuous reporting of new cases in Spain supports the relationship between Herbalife® products and liver injury. Pharmacoepidemiol. Dr. S., v.20, n.10, p.1080-1087, 2011.
28. SCHOEPFER, A.M.; ELGEL, A.; FATTINGER, K.; MARBET, U.; CRIBLEZ, D.; REICHEN, J.; ZIMMERMANN, A.; ONETA, C. Herbal does not mean innocuous: Ten cases of severe hepatotoxicity associated with dietary supplements from Herbalife® products. J. Hepatol., v.47, n.4, p.521-526, 2007.
29. SEEF, L.B. Are herbals as safe as their advocates believe? J. Hepatol., v.50, n.1, p.13-16, 2009.
30. SCHILTER, B.; ANDERSSON, C.; ANTON, R.; CONSTABLE, A.; KLEINER, J.; O'BRIEN, J.; RENWICK A.; KORVER, O.; SMIT; F.; WALKER, R. Guidance for the safety assessment of botanicals and botanicals preparations for use in food and food suplements. Food Chem. Toxicol., v.41, n.12, p.1625-1649, 2003.
31. SCHMITZ, S.; LOPEZ, H.; MACKAY, D. Nutravigilance: principles and practices to enhance adverse event reporting in the dietary supplement and natural products industry. Int. J. Food Sci. Nutr., v.65, n.2, p.129-34, 2014.
32. SPEIJERS, G., BOTTEX, B.; DUSEMUND, B.; LUGASI, A.; TÓTH, J.; AMBERG-MULLER, J.; GALLI, C.; SILANO, V.; RIETJENS, I. Safety assessment of botanicals and botanical preparations used as ingredients in food supplements: testing an european food safety authority tiered approach. Mol. Nutr. Food Res., v.54, n.2, p.175-185, 2010.
33. STICKEL, F.; KESSEBOHM, K.; WEIMANN, R.; SEITZ, H.K. Review of liver injury associated with dietary supplements. Liver Int., v.31, n.5, p.595-605, 2011.
34. STICKEL, F.; DROZ, S.; PATSENKER, E.; BOGLI-STUBER, K.; AEBI, B.; LEIB., S. Severe hepatotoxicity following ingestion of Herbalife® nutritional supplements contaminated with Bacillus subtilis. J. Hepatol., v.50, n.1, p.111-117, 2009.
35. STICKEL, F.; SHOUVAL, D. Hepatotoxicity of herbal and dietary supplements: an update. Arch. Toxicol., v.89, n.6, p.851-865, 2015.
36. TESCHKE, R.; FRENZEL, C.; GLASS, X.; SCHULZE, J.; EICKHOFF, A. Herbal hepatotoxicity: a critical review. Br. J. Clin. Pharmacol., v.75, n.3, p.630-636, 2012a.
37. TESCHKE, R.; WOLFF, A.; FRENZEL, C.; SCHULZE, J. EICKHOFF, A. Herbal hepatotoxicity: a tabular compilation of reported cases. Liver Int., v.32, n.10, p.1543-1556, 2012b.
38. TESCHKE, R.; Herbal hepatotoxicity and WHO global introspection method. Ann. Hepatol., v.12, n.1, p.11-21, 2013a.
39. TESCHKE, R.; SCHULZE, J.; SCHWARZENBOECK, A.; EICKHOFF, A.; FRENZEL, C. Herbal hepatotoxicity: suspected cases assessed for alternative causes. Eur. J. Gastroen. Hepatol., v.25, n.9, p.1093-1098, 2013b.
40. TESCHKE, R.; FRENZEL, C.; SCHULZE, J.; SCHWARZENBOECK, A.; EICKHOFF, A. Herbalife hepatotoxicity: Evaluation of cases with positive reexposure tests. World J. Hepatol., v.5, n.7, p.353-363, 2013c.
41. VAN BREEMAN, R.B.; FONG, H.H.S.; FARNSWORTH, N.R. Ensuring the safety of botanical dietary supplements. Am. J. Clin. Nutr, v.87, Suppl., p.509S-513S, 2008.