Investigation of the Role of Chemical Analysis in Causality Assessment of Herbal and Dietary Supplement-Induced Liver Injury.

IF 4 2区医学 Q1 PHARMACOLOGY & PHARMACY Drug Safety Pub Date : 2024-10-01 DOI:10.1007/s40264-024-01484-8

Dina Halegoua-DeMarzio, Victor J Navarro, Ashley Davis, Jawad Ahmad, Bharathi Avula, Huiman Barnhart, A Sidney Barritt, Herbert L Bonkovsky, Vincent L Chen, Gina Choi, Robert J Fontana, Marwan S Ghabril, Ikhlas Khan, Christopher Koh, Joseph Odin, Don C Rockey, Hoss Rostami, Jose Serrano, Averell H Sherker, Andrew Stolz, Hans L Tillmann, Raj Vuppalanchi

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Abstract

Background: The attribution of drug-induced liver injury (DILI) to specific herbal and dietary supplements (HDS) is confounded by inaccurate labels and undisclosed ingredients. The US Drug-Induced Liver Injury Network (DILIN) determines the attribution of injury to an agent through its structured expert opinion causality assessment process, but without the use of chemical analysis data of HDS. We aimed to determine the impact of chemical analysis of HDS products on prior causality assessment scores.

Methods: Obtained samples of HDS consumed by DILIN-enrolled patients were analyzed by high-performance liquid chromatography-mass spectrometry (HPLC-MS). Chemical analysis data were compared to label accuracy and detect whether the product contained botanical and non-botanical compounds. A comparison of the causality scores reassessed with chemical analysis was compared with the original scores.

Results: A total of 54 previously adjudicated cases with chemical analysis available were reassessed for causality with chemical analysis data; reviewers were blinded to original causality scores. Using the chemical analysis data, 37% (n = 20) of the 54 cases were scored with a higher likelihood of DILI compared with the original causality scores; 14 of the 20 (70%) moved from probable to highly likely; 52% had no change in causality score; and 11% of cases were scored as a lower likelihood of DILI.

Conclusions: Our study demonstrates that there is value in using HDS chemical analysis data in the causality assessment process for DILI. In more than a third of cases, chemical analysis of products led to an increased confidence in DILI attribution to HDS. These findings suggest that chemical analysis is an important tool in causality assessment for HDS agents, specifically in challenging situations, and further studies are needed to confirm its applicability in clinical practice.

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调查化学分析在草药和膳食补充剂诱发肝损伤的因果关系评估中的作用

背景：药物性肝损伤（DILI）与特定草药和膳食补充剂（HDS）的归属问题因标签不准确和成分未披露而受到混淆。美国药物性肝损伤网络（DILIN）通过其结构化的专家意见因果关系评估程序来确定损伤是否归因于某种药物，但不使用 HDS 的化学分析数据。我们旨在确定 HDS 产品的化学分析对先前因果关系评估得分的影响：通过高效液相色谱-质谱法（HPLC-MS）对加入 DILIN 的患者所食用的 HDS 样品进行分析。将化学分析数据与标签准确性进行比较，并检测产品是否含有植物和非植物化合物。通过化学分析重新评估的因果关系得分与原始得分进行了比较：利用化学分析数据重新评估了 54 个先前已裁定但有化学分析数据的病例的因果关系；审查人员对最初的因果关系评分是盲法。使用化学分析数据后，与原始因果关系评分相比，54 个病例中有 37% （n = 20）的 DILI 可能性更高；20 个病例中有 14 个病例（70%）的因果关系评分从可能变为极有可能；52% 的病例因果关系评分没有变化；11% 的病例 DILI 可能性较低：我们的研究表明，在 DILI 的因果关系评估过程中使用 HDS 化学分析数据是有价值的。在超过三分之一的案例中，对产品的化学分析提高了将 DILI 归因于 HDS 的可信度。这些研究结果表明，化学分析是对 HDS 制剂进行因果关系评估的重要工具，特别是在具有挑战性的情况下。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Drug Safety 医学-毒理学

CiteScore

7.60

自引率

7.10%

发文量

112

审稿时长

6-12 weeks

期刊介绍： Drug Safety is the official journal of the International Society of Pharmacovigilance. The journal includes: Overviews of contentious or emerging issues. Comprehensive narrative reviews that provide an authoritative source of information on epidemiology, clinical features, prevention and management of adverse effects of individual drugs and drug classes. In-depth benefit-risk assessment of adverse effect and efficacy data for a drug in a defined therapeutic area. Systematic reviews (with or without meta-analyses) that collate empirical evidence to answer a specific research question, using explicit, systematic methods as outlined by the PRISMA statement. Original research articles reporting the results of well-designed studies in disciplines such as pharmacoepidemiology, pharmacovigilance, pharmacology and toxicology, and pharmacogenomics. Editorials and commentaries on topical issues. Additional digital features (including animated abstracts, video abstracts, slide decks, audio slides, instructional videos, infographics, podcasts and animations) can be published with articles; these are designed to increase the visibility, readership and educational value of the journal’s content. In addition, articles published in Drug Safety Drugs may be accompanied by plain language summaries to assist readers who have some knowledge of, but not in-depth expertise in, the area to understand important medical advances.