Identifying Herbal Adverse Events From Spontaneous Reporting Systems Using Taxonomic Name Resolution Approach

Abstract

The efficacy and safety of herbal supplements suffer from challenges due to non-uniform representation of ingredient terms within biomedical and observational health data sources. The nature of how supplement data are reported within Spontaneous Reporting Systems (SRS) can limit analyses of supplement-associated adverse events due to the use of incorrect nomenclature or failing to identify herbs. This study aimed to extract, standardize, and summarize supplement-relevant reports from two SRSs: (1) Food and Drug Administration Adverse Event Reporting System (FAERS) and (2) Canada Vigilance Adverse Reaction (CVAR) database. A thesaurus of plant names was developed and integrated with a mapping and normalization approach that accommodated misspellings and variants. The reports gathered from FAERS between the years 2004 and 2016 show 185,915 herbal and 7,235,330 non-herbal accounting for 2.51%. The data from CVAR found 36,940 reports of herbal and 503,580 non-herbal reports between the years 1965 and 2017 for a total of 6.83%. Although not all cases were actual adverse events due to numerous variables and incomplete reporting, it is interesting to note that the herbs most frequently reported and significantly associated with adverse events were as follows: Avena sativa (Oats), Cannabis sativa (marijuana), Digitalis purpurea (foxglove), Humulus lupulus (hops), Hypericum perforatum (St John’s Wort), Paullinia cupana (guarana), Phleum pretense (timothy-grass), Silybum marianum (milk thistle), Taraxacum officinale (Dandelion), and Valeriana officinalis (valerian). Using a scalable approach for mapping and resolution of herb names allowed data-driven exploration of potential adverse events from sources that have remained isolated in this specific area of research. The results from this study highlight several herb-associated safety issues providing motivation for subsequent in-depth analyses, including those that focus on the scope and severity of potential safety issues with supplement use.

An overview of global monitoring systems for the side effects and adverse events associated with medicinal cannabis use: A scoping review using a systematic approach

“…The Quebec Cannabis Registry, established in 2015, ceased data collection in 2018. Serious adverse events were reported to the Canada Vigilance Database for evaluation (37-40). The Registry collected data in the UK from 2012 until 2015, however data collection in Germany and Switzerland remains ongoing (31,43,44).…”

Clinical Implications of Herbal Supplements in Conventional Medical Practice: A US Perspective

“…Information about potential herb-related adverse reactions is very limited [101]. Estimates of adverse events related to dietary supplements (including herbs) suggest that only 1% of cases are reported to the FDA [102].…”

“…Due to poor regulation of herbal products, impurities like allergens, pollen, and spores and batch-to-batch variability could contribute to some of the reported herb-related adverse effects and drug interactions [ 100 ]. Information about potential herb-related adverse reactions is very limited [ 101 ]. Estimates of adverse events related to dietary supplements (including herbs) suggest that only 1% of cases are reported to the FDA [ 102 ].…”

“…Estimates of adverse events related to dietary supplements (including herbs) suggest that only 1% of cases are reported to the FDA [ 102 ]. A manual review of case reports from PubMed identified approximately 21, seven, and seven herbs as being risks for liver, kidney, and heart toxicity, respectively [ 101 ]. Currently, advancement in modern technology is continually improving how ADRs are predicted, prevented, detected, and managed [ 95 ].…”

Nephrotoxicity of Herbal Products in Europe—A Review of an Underestimated Problem

“…The detection of potential adverse signals of herbal adverse reactions, especially the serious ones that result in death, hospitalization, or significant disability, is challenging, but we should remember that plant-based remedies are not risk-free. Everybody needs to be informed about the possible adverse events, including undesirable effects or interactions with other herbs or synthetic medications [ 72 , 73 ]. Both pharmacokinetic and pharmacodynamic interactions are distinguishable, but identification is difficult because herbal medicines can contain even more than 150 ingredients, and, additionally, they are poorly reported and documented, which is also affected by the lack of information provided by patients to doctors.…”