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Suspected herbal hepatotoxicity: requirements for appropriate causality assessment by the US Pharmacopeia.
Drug Saf 2012; 35(12):1091-7DS

Abstract

The aim of this current opinion report is to discuss relevant issues of regulatory causality assessment methods related to initially suspected herb-induced liver injury (HILI). Herbal hepatotoxicity represents a major clinical, regulatory and public challenge since its diagnosis may be difficult to be established, requiring a sophisticated approach that includes a liver-specific and validated causality assessment method. In cases of primarily suspected HILI, however, problems emerged when the US Pharmacopeia (USP) published results with causality assessments of liver disease cases. In these studies, herbal drugs and herbal dietary supplements were considered as causative products based on causality attribution by a shortened version of the Naranjo scale. However, the Naranjo scale is not liver specific and not validated for liver toxicity, and these shortcomings also apply to its shortened and thereby modified version. Consequently, these results were questioned and considered invalid, requiring re-evaluation with a liver-specific causality assessment method validated for hepatotoxicity, such as the scale of the Council for International Organizations of Medical Sciences (CIOMS) or its validated update. In essence, the USP and other regulatory agencies should apply validated liver-specific causality assessment methods rather than liver unspecific and not validated assessment methods in suspected HILI cases.

Authors+Show Affiliations

Department of Internal Medicine II, Division of Gastroenterology and Hepatology, Klinikum Hanau, Academic Teaching Hospital of the Medical Faculty of the Goethe University, FrankfurtMain, Germany.No affiliation info available

Pub Type(s)

Journal Article

Language

eng

PubMed ID

22897137

Citation

Teschke, Rolf, and Johannes Schulze. "Suspected Herbal Hepatotoxicity: Requirements for Appropriate Causality Assessment By the US Pharmacopeia." Drug Safety, vol. 35, no. 12, 2012, pp. 1091-7.
Teschke R, Schulze J. Suspected herbal hepatotoxicity: requirements for appropriate causality assessment by the US Pharmacopeia. Drug Saf. 2012;35(12):1091-7.
Teschke, R., & Schulze, J. (2012). Suspected herbal hepatotoxicity: requirements for appropriate causality assessment by the US Pharmacopeia. Drug Safety, 35(12), pp. 1091-7. doi:10.2165/11631960-000000000-00000.
Teschke R, Schulze J. Suspected Herbal Hepatotoxicity: Requirements for Appropriate Causality Assessment By the US Pharmacopeia. Drug Saf. 2012 Dec 1;35(12):1091-7. PubMed PMID: 22897137.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Suspected herbal hepatotoxicity: requirements for appropriate causality assessment by the US Pharmacopeia. AU - Teschke,Rolf, AU - Schulze,Johannes, PY - 2012/8/18/entrez PY - 2012/8/18/pubmed PY - 2013/4/17/medline SP - 1091 EP - 7 JF - Drug safety JO - Drug Saf VL - 35 IS - 12 N2 - The aim of this current opinion report is to discuss relevant issues of regulatory causality assessment methods related to initially suspected herb-induced liver injury (HILI). Herbal hepatotoxicity represents a major clinical, regulatory and public challenge since its diagnosis may be difficult to be established, requiring a sophisticated approach that includes a liver-specific and validated causality assessment method. In cases of primarily suspected HILI, however, problems emerged when the US Pharmacopeia (USP) published results with causality assessments of liver disease cases. In these studies, herbal drugs and herbal dietary supplements were considered as causative products based on causality attribution by a shortened version of the Naranjo scale. However, the Naranjo scale is not liver specific and not validated for liver toxicity, and these shortcomings also apply to its shortened and thereby modified version. Consequently, these results were questioned and considered invalid, requiring re-evaluation with a liver-specific causality assessment method validated for hepatotoxicity, such as the scale of the Council for International Organizations of Medical Sciences (CIOMS) or its validated update. In essence, the USP and other regulatory agencies should apply validated liver-specific causality assessment methods rather than liver unspecific and not validated assessment methods in suspected HILI cases. SN - 1179-1942 UR - https://www.unboundmedicine.com/medline/citation/22897137/Suspected_herbal_hepatotoxicity:_requirements_for_appropriate_causality_assessment_by_the_US_Pharmacopeia_ L2 - https://dx.doi.org/10.2165/11631960-000000000-00000 DB - PRIME DP - Unbound Medicine ER -