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Regulatory causality evaluation methods applied in kava hepatotoxicity: are they appropriate?
Regul Toxicol Pharmacol 2011; 59(1):1-7RT

Abstract

Since 1998 liver injury has been assumed in some patients after the use of kava (Piper methysticum G. Forster) as an anxyolytic herbal extract, but the regulatory causality evaluation of these cases was a matter of international and scientific debate. This review critically analyzes the regulatory issues of causality assessments of patients with primarily suspected kava hepatotoxicity and suggests recommendations for minimizing regulatory risks when assessing causality in these and other related cases. The various regulatory causality approaches were based on liver unspecific assessments such as ad hoc evaluations, the WHO scale using the definitions of the WHO Collaborating Centre for International Drug Monitoring, and the Naranjo scale. Due to their liver unspecificity, however, these causality approaches are not suitable for assessing cases of primarily assumed liver related adverse reactions by drugs and herbs including kava. Major problems emerged trough the combination of regulatory inappropriate causality assessment methods with the poor data quality as presented by the regulatory agency when reassessment was done and the resulting data were heavily criticized worldwide within the scientific community. Conversely, causality of cases with primarily assumed kava hepatotoxicity is best assessed by structured, quantitative and liver specific causality algorithms such as the scale of the CIOMS (Council for International Organizations of Medical Sciences) or the main-test as its update. Future strategies should therefore focus on the implementation of structured, quantitative and liver specific causality assessment methods as regulatory standards to improve regulatory causality assessments for liver injury by drugs and herbs including kava.

Authors+Show Affiliations

Department of Internal Medicine II, Division of Gastroenterology and Hepatology, Klinikum Hanau, Teaching Hospital of the Johann Wolfgang Goethe-University of Frankfurt/Main, Germany. rolf.teschke@gmx.deNo affiliation info available

Pub Type(s)

Journal Article
Review

Language

eng

PubMed ID

20854865

Citation

Teschke, Rolf, and Albrecht Wolff. "Regulatory Causality Evaluation Methods Applied in Kava Hepatotoxicity: Are They Appropriate?" Regulatory Toxicology and Pharmacology : RTP, vol. 59, no. 1, 2011, pp. 1-7.
Teschke R, Wolff A. Regulatory causality evaluation methods applied in kava hepatotoxicity: are they appropriate? Regul Toxicol Pharmacol. 2011;59(1):1-7.
Teschke, R., & Wolff, A. (2011). Regulatory causality evaluation methods applied in kava hepatotoxicity: are they appropriate? Regulatory Toxicology and Pharmacology : RTP, 59(1), pp. 1-7. doi:10.1016/j.yrtph.2010.09.006.
Teschke R, Wolff A. Regulatory Causality Evaluation Methods Applied in Kava Hepatotoxicity: Are They Appropriate. Regul Toxicol Pharmacol. 2011;59(1):1-7. PubMed PMID: 20854865.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Regulatory causality evaluation methods applied in kava hepatotoxicity: are they appropriate? AU - Teschke,Rolf, AU - Wolff,Albrecht, Y1 - 2010/09/18/ PY - 2010/07/20/received PY - 2010/08/27/revised PY - 2010/09/10/accepted PY - 2010/9/22/entrez PY - 2010/9/22/pubmed PY - 2011/7/12/medline SP - 1 EP - 7 JF - Regulatory toxicology and pharmacology : RTP JO - Regul. Toxicol. Pharmacol. VL - 59 IS - 1 N2 - Since 1998 liver injury has been assumed in some patients after the use of kava (Piper methysticum G. Forster) as an anxyolytic herbal extract, but the regulatory causality evaluation of these cases was a matter of international and scientific debate. This review critically analyzes the regulatory issues of causality assessments of patients with primarily suspected kava hepatotoxicity and suggests recommendations for minimizing regulatory risks when assessing causality in these and other related cases. The various regulatory causality approaches were based on liver unspecific assessments such as ad hoc evaluations, the WHO scale using the definitions of the WHO Collaborating Centre for International Drug Monitoring, and the Naranjo scale. Due to their liver unspecificity, however, these causality approaches are not suitable for assessing cases of primarily assumed liver related adverse reactions by drugs and herbs including kava. Major problems emerged trough the combination of regulatory inappropriate causality assessment methods with the poor data quality as presented by the regulatory agency when reassessment was done and the resulting data were heavily criticized worldwide within the scientific community. Conversely, causality of cases with primarily assumed kava hepatotoxicity is best assessed by structured, quantitative and liver specific causality algorithms such as the scale of the CIOMS (Council for International Organizations of Medical Sciences) or the main-test as its update. Future strategies should therefore focus on the implementation of structured, quantitative and liver specific causality assessment methods as regulatory standards to improve regulatory causality assessments for liver injury by drugs and herbs including kava. SN - 1096-0295 UR - https://www.unboundmedicine.com/medline/citation/20854865/Regulatory_causality_evaluation_methods_applied_in_kava_hepatotoxicity:_are_they_appropriate L2 - https://linkinghub.elsevier.com/retrieve/pii/S0273-2300(10)00159-5 DB - PRIME DP - Unbound Medicine ER -