Analysis of suspected serious adverse drug reactions reported with traditional medicines from the United Nations Asia region in WHO vigibase.

BACKGROUND: Traditional medicines (TMs) are not regulated like conventional drugs in many countries, and they are often perceived as safe, which leads to large-scale self-medication. There is limited safety information available for TMs. Thus, including them in pharmacovigilance systems is crucial for systematically gathering and evaluating adverse drug reactions (ADRs) to enhance safety and prevent harm with their use. Therefore, this study analyzed the pattern of serious suspected ADRs reported with TMs to the WHO Uppsala Monitoring Center. METHODS: Individual Case Safety Reports (ICSRs) from January 1, 2016, to June 30, 2021, from the UN Asia region were included, which reported events suspected to be associated with TMs. ADRs resulting in hospital admission/prolongation of hospital stay, disability, life-threatening conditions, congenital abnormality, or death were considered serious ADRs. Demographic details, patterns of reported ADRs, and suspected TMs were analyzed along with the outcome of events. RESULTS: There were 713 suspected serious ICSRs with at least one TM as a suspected drug reported, which accounted for 2.5% of the total reports. Skin and subcutaneous tissue disorders (19.8%), hepatobiliary disorders (15.3%), and gastrointestinal disorders (12.9%) were commonly reported system organ classes. Asymptomatic elevation of liver markers (8.8%) was the most common reaction, followed by vomiting (4.1%), dyspnoea (3.1%), drug-induced liver injury (3%), diarrhoea (3%), rash (2.8%), and urticaria (2.6%). Artemisia argyi (4.9%), Vitis vinifera (3.6%), Andrographis paniculata (2%), Ginkgo biloba (1.7%), Silybum marianum (1.5%), and Tinospora cordifolia (1.5%) were the most frequently suspected TMs. Seventeen (2.4%) ICSRs had a fatal outcome. CONCLUSIONS: The present analysis revealed that various TMs have the potential to cause serious ADRs, particularly affecting the skin and subcutaneous tissue, the hepatobiliary system, and the gastrointestinal system. Their comprehensive list presented in the study will be valuable for promoting the safe use of TMs.