Article type
Abstract
"Background: Systematic collection and dissemination of adverse event data linked to herbal medicine products play a pivotal role in bolstering patient safety and guiding clinical practice. This study employs a thorough approach to examine adverse event reports associated with herbal medicine products in Korea, drawing insights from the Korea Adverse Event Reporting System (KAERS) database spanning from 2012 to 2021. The data used in this study were sourced from the KAERS database, which is generated by both public and consumer reports.
Objectives: This study aims to offer a comprehensive overview utilizing Korea’s pharmacovigilance system, with a specific focus on extracting and analyzing adverse event data related to herbal medicine products from the KAERS database between 2012 and 2021.
Methods: Individual case safety reports (ICSRs) of herbal medicine products were extracted from the KAERS database and systematically analyzed. Descriptive statistics were utilized to categorize and analyze adverse event data based on the MedDRA System Organ Class (SOC) and preferred term classification. Furthermore, we identified hepatobiliary adverse drug reactions, pulmonary adverse drug reactions, anaphylactic responses, and pseudoaldosteronism as adverse reactions requiring careful observation specifically related to herbal medicine products.
Results: Analysis of 1,054 ICSRs yielded 1,629 extracted adverse events. The most frequently reported System Organ Class (SOC) categories included gastrointestinal disorders (28.7%), skin and subcutaneous tissue disorders (20.1%), and nervous system disorders (11.4%). Notably, gastrointestinal disorders commonly featured diarrhea, abdominal discomfort, and dyspepsia, while skin and subcutaneous tissue disorders predominantly presented urticaria, pruritus, and rash. Specifically examining critical adverse events, 53 cases of hepatobiliary adverse events, characterized by elevated liver enzyme levels, were identified. Pulmonary adverse events, primarily dyspnea and cough, were reported in 44 cases. Anaphylactic responses were documented in 9 cases, while no instances of pseudoaldosteronism were observed.
Conclusion: This study underscores the critical importance of systematically collecting and disseminating real-world data on adverse events linked to herbal medicine products. By systematically analyzing and sharing this information, stakeholders can make informed decisions to enhance patient safety and elevate the standard of clinical care in the herbal medicine field."
Objectives: This study aims to offer a comprehensive overview utilizing Korea’s pharmacovigilance system, with a specific focus on extracting and analyzing adverse event data related to herbal medicine products from the KAERS database between 2012 and 2021.
Methods: Individual case safety reports (ICSRs) of herbal medicine products were extracted from the KAERS database and systematically analyzed. Descriptive statistics were utilized to categorize and analyze adverse event data based on the MedDRA System Organ Class (SOC) and preferred term classification. Furthermore, we identified hepatobiliary adverse drug reactions, pulmonary adverse drug reactions, anaphylactic responses, and pseudoaldosteronism as adverse reactions requiring careful observation specifically related to herbal medicine products.
Results: Analysis of 1,054 ICSRs yielded 1,629 extracted adverse events. The most frequently reported System Organ Class (SOC) categories included gastrointestinal disorders (28.7%), skin and subcutaneous tissue disorders (20.1%), and nervous system disorders (11.4%). Notably, gastrointestinal disorders commonly featured diarrhea, abdominal discomfort, and dyspepsia, while skin and subcutaneous tissue disorders predominantly presented urticaria, pruritus, and rash. Specifically examining critical adverse events, 53 cases of hepatobiliary adverse events, characterized by elevated liver enzyme levels, were identified. Pulmonary adverse events, primarily dyspnea and cough, were reported in 44 cases. Anaphylactic responses were documented in 9 cases, while no instances of pseudoaldosteronism were observed.
Conclusion: This study underscores the critical importance of systematically collecting and disseminating real-world data on adverse events linked to herbal medicine products. By systematically analyzing and sharing this information, stakeholders can make informed decisions to enhance patient safety and elevate the standard of clinical care in the herbal medicine field."