Article Text

Download PDFPDF

5PSQ-026 The potential of pharmacovigilance databases to assess toxicological risk of dietary supplements and other unsupervised health products used by patients
  1. B Orsolya,
  2. BM Domián,
  3. AR Ashraf,
  4. AT Fittler,
  5. RG Vida
  1. University of Pécs Faculty of Pharmacy, Department of Pharmaceutics and Central Clinical Pharmacy, Pécs, Hungary


Background and Importance When executing the medication use review or medication reconciliation, and if there is a sudden new symptom or sign of toxicity, the potential role of health products taken by patients without the supervision of the health care professionals should not be forgotten. However, there is no standardised approach to assess toxicity of these products in everyday practice.

Aim and Objectives Our aim was to search for and evaluate methods that can be added or standardised to assess illegal or unsupervised health products from toxicological perspective. We wanted to know whether there any databases that can be used and if they are eligible for this role based on information content or applicability.

Material and Methods In addition to the literature search, we identified and reviewed four Open Access databases: EudraVigilance; US FDA Adverse Events Reporting System (FAERS); US FDA CFSAN Adverse Event Reporting System (CAERS); Health Fraud Product Database. For the initial screening we chose as a model substance cannabidiol (CBD) (excluding authorised medicines) due to its popularity and potential adverse effects.

Results We identified 371 cases in the EudraVigilance database from 2021 to 2023 (2021: 126, 2022: 196, 2023: 49). Fatal cases were 7.55% of all cases (n=28). From the concomitant medications used with CBD, clobazam was the most frequent (n=16). In the FAERS database there 276 cases were registered from 2015 to 2023, with 67.4% (n=186) being severe and 2.5% (n=7) fatal. The three most common reactions identified were: General disorders and administration site conditions (n=117), Nervous system disorders (n=103) and Psychiatric disorders (n=85). In the CAERS database 163 cases were found (2016–2023) with one fatal. The most common reactions with MedDRA preferred terms were related to gastrointestinal disorders (e.g.: diarrhoea, vomiting, nausea). In the Health Fraud Product Database CBD related cases were 33 in the period of 2019–2021.

Conclusion and Relevance The application of open access databases containing pharmacovigilance and toxicovigilance data are suitable for assessing the real-world toxicity of dietary supplements and identifying high risk products. The incorporation of our results into the clinical practice can be a competency of a clinical pharmacist.

Conflict of Interest No conflict of interest.

Statistics from

Request Permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.