Analysis of Hepatobiliary Disorder Reports Associated With the Use of Herbal Medicines in the Global Suspected ADR Database Vigibase
Introduction: Use of herbal medicines (HMs) is widespread across the world, with many people relying on HMs for their primary healthcare or using HMs in the context of a healthy life style. HMs originate from plant material and, as such, are often seen as “natural” and believed to be (relatively) sa...
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| Format: | Article |
| Language: | English |
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Frontiers Media S.A.
2019-11-01
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| Series: | Frontiers in Pharmacology |
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| Online Access: | https://www.frontiersin.org/article/10.3389/fphar.2019.01326/full |
| _version_ | 1798045950615224320 |
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| author | Florence van Hunsel Sonja van de Koppel Souad Skalli Andrea Kuemmerle Andrea Kuemmerle Lida Teng Jia-bo Wang Joanne Barnes |
| author_facet | Florence van Hunsel Sonja van de Koppel Souad Skalli Andrea Kuemmerle Andrea Kuemmerle Lida Teng Jia-bo Wang Joanne Barnes |
| author_sort | Florence van Hunsel |
| collection | DOAJ |
| description | Introduction: Use of herbal medicines (HMs) is widespread across the world, with many people relying on HMs for their primary healthcare or using HMs in the context of a healthy life style. HMs originate from plant material and, as such, are often seen as “natural” and believed to be (relatively) safe by patients. Hepatobiliary disorders have been associated with numerous HMs.Aim: This paper aims to analyze reporting patterns for hepatobiliary disorders associated with HMs use from reports submitted to the WHO global database of individual case safety reports (ICSRs) VigiBase.Methods: A data extraction in VigiBase, the WHO international database of ICSR reports, was performed by the Uppsala Monitoring Centre on 2019-01-16. The dataset contained all ICSRs where an HM was identified with the UMC-assigned ATC code “V90: unspecified herbal and traditional medicine” and where the HM was classified as being either the suspected drug or an interacting drug, and containing at least one adverse reaction in the MedDRA® System Organ Class (SOC) Hepatobiliary Disorders (HBD). Descriptive analyses in Excel 2013® were used to determine general characteristics of the reports in the broad data set, including total number of reports, reporting country and patient characteristics. For single suspect herbal reports, reports categorized as “serious” according to CIOMS criteria (CIOMS), 2001) were extracted.Results: In total, 2,483 reports describing with at least one ADR in the SOC HBD were extracted from VigiBase. In total, 780 (31.4%) reports concern only one suspect HM. However, for 188 reports of these reports (24.1%), the single suspect herbal preparation contains more than one herbal ingredient. The 592 reports for single suspect herbal preparations described a total of 764 ADRs in the SOC HBD. Jaundice was the most reported ADR for these reports.Conclusion: Almost 2,500 reports for HMs and with at least one ADR coded to the MedDRA® SOC HBD were retrieved from VigiBase. Of the HBD SOC HM reports, around 25% concerned a single herbal species as the suspect “drug.” Substantial issues with coding of the suspect herbal drugs were found. In-depth causality assessment of the cases is needed to draw conclusions on the strength of the relationships. |
| first_indexed | 2024-04-11T23:29:37Z |
| format | Article |
| id | doaj.art-f75a6943c68d4aa7a491d4c607beee5f |
| institution | Directory Open Access Journal |
| issn | 1663-9812 |
| language | English |
| last_indexed | 2024-04-11T23:29:37Z |
| publishDate | 2019-11-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Pharmacology |
| spelling | doaj.art-f75a6943c68d4aa7a491d4c607beee5f2022-12-22T03:57:11ZengFrontiers Media S.A.Frontiers in Pharmacology1663-98122019-11-011010.3389/fphar.2019.01326481230Analysis of Hepatobiliary Disorder Reports Associated With the Use of Herbal Medicines in the Global Suspected ADR Database VigibaseFlorence van Hunsel0Sonja van de Koppel1Souad Skalli2Andrea Kuemmerle3Andrea Kuemmerle4Lida Teng5Jia-bo Wang6Joanne Barnes7The Netherlands Pharmacovigilance Centre Lareb, ‘s-Hertogenbosch, NetherlandsThe Netherlands Pharmacovigilance Centre Lareb, ‘s-Hertogenbosch, NetherlandsMicrobiology and Molecular Biology Team, Center of Plant and Microbial Biotechnology, Biodiversity and Environment, Faculty of Sciences, Mohammed V University in Rabat, Rabat, MoroccoDepartment of Medicine, Swiss Tropical and Public Health Institute, Basel, SwitzerlandUniversity of Basel, Basel, SwitzerlandDepartment of Health Economics and Outcomes Research, Graduate School of Pharmaceutical Sciences, The University of Tokyo, Tokyo, JapanInstitute of Chinese Herbal Medicine, Beijing Integrative Medical Center for Liver Diseases, Beijing 302 Hospital of China, Beijing, ChinaSchool of Pharmacy, The University of Auckland, Auckland, New ZealandIntroduction: Use of herbal medicines (HMs) is widespread across the world, with many people relying on HMs for their primary healthcare or using HMs in the context of a healthy life style. HMs originate from plant material and, as such, are often seen as “natural” and believed to be (relatively) safe by patients. Hepatobiliary disorders have been associated with numerous HMs.Aim: This paper aims to analyze reporting patterns for hepatobiliary disorders associated with HMs use from reports submitted to the WHO global database of individual case safety reports (ICSRs) VigiBase.Methods: A data extraction in VigiBase, the WHO international database of ICSR reports, was performed by the Uppsala Monitoring Centre on 2019-01-16. The dataset contained all ICSRs where an HM was identified with the UMC-assigned ATC code “V90: unspecified herbal and traditional medicine” and where the HM was classified as being either the suspected drug or an interacting drug, and containing at least one adverse reaction in the MedDRA® System Organ Class (SOC) Hepatobiliary Disorders (HBD). Descriptive analyses in Excel 2013® were used to determine general characteristics of the reports in the broad data set, including total number of reports, reporting country and patient characteristics. For single suspect herbal reports, reports categorized as “serious” according to CIOMS criteria (CIOMS), 2001) were extracted.Results: In total, 2,483 reports describing with at least one ADR in the SOC HBD were extracted from VigiBase. In total, 780 (31.4%) reports concern only one suspect HM. However, for 188 reports of these reports (24.1%), the single suspect herbal preparation contains more than one herbal ingredient. The 592 reports for single suspect herbal preparations described a total of 764 ADRs in the SOC HBD. Jaundice was the most reported ADR for these reports.Conclusion: Almost 2,500 reports for HMs and with at least one ADR coded to the MedDRA® SOC HBD were retrieved from VigiBase. Of the HBD SOC HM reports, around 25% concerned a single herbal species as the suspect “drug.” Substantial issues with coding of the suspect herbal drugs were found. In-depth causality assessment of the cases is needed to draw conclusions on the strength of the relationships.https://www.frontiersin.org/article/10.3389/fphar.2019.01326/fullherbal medicineshepatobiliary disordersadverse drug reactionsVigiBasepharmacovigilance |
| spellingShingle | Florence van Hunsel Sonja van de Koppel Souad Skalli Andrea Kuemmerle Andrea Kuemmerle Lida Teng Jia-bo Wang Joanne Barnes Analysis of Hepatobiliary Disorder Reports Associated With the Use of Herbal Medicines in the Global Suspected ADR Database Vigibase Frontiers in Pharmacology herbal medicines hepatobiliary disorders adverse drug reactions VigiBase pharmacovigilance |
| title | Analysis of Hepatobiliary Disorder Reports Associated With the Use of Herbal Medicines in the Global Suspected ADR Database Vigibase |
| title_full | Analysis of Hepatobiliary Disorder Reports Associated With the Use of Herbal Medicines in the Global Suspected ADR Database Vigibase |
| title_fullStr | Analysis of Hepatobiliary Disorder Reports Associated With the Use of Herbal Medicines in the Global Suspected ADR Database Vigibase |
| title_full_unstemmed | Analysis of Hepatobiliary Disorder Reports Associated With the Use of Herbal Medicines in the Global Suspected ADR Database Vigibase |
| title_short | Analysis of Hepatobiliary Disorder Reports Associated With the Use of Herbal Medicines in the Global Suspected ADR Database Vigibase |
| title_sort | analysis of hepatobiliary disorder reports associated with the use of herbal medicines in the global suspected adr database vigibase |
| topic | herbal medicines hepatobiliary disorders adverse drug reactions VigiBase pharmacovigilance |
| url | https://www.frontiersin.org/article/10.3389/fphar.2019.01326/full |
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