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Analysis of Reports on Adverse Drug Reactions Related to Herbal Medicinal Products and Herbal Supplements in the Netherlands Received by the National Pharmacovigilance Centre Lareb

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Abstract

Introduction

The inclusion of herbal medicinal products and herbal supplements in pharmacovigilance systems is important because a systematic approach of collecting and analyzing adverse drug reactions related to these products will help practitioners, patients, and regulators to gain more knowledge and prevent harm.

Objective

We aimed to categorize the adverse drug reaction reports on herbal medicinal products and herbal supplements submitted to the Pharmacovigilance Centre Lareb between 1991 and February 2021 on the basis of their regulatory status, herbs included, and adverse drug reactions involved.

Methods

We categorized products on the basis of their registration status and herbal ingredients. The products were then categorized according to the Herbal Anatomical Therapeutic Chemical Classification System. We used descriptive statistics in Microsoft Excel 2019. Pivot tables were used for the analysis and presentation of the data.

Results

Until February 2021, a total of 789 reports of herbal medicinal products and herbal supplements were received by Lareb. In these reports, a total of 823 herbal products were labeled as suspect. These products caused a total of 1727 adverse drug reactions. Of the 823 products, 229 were registered as a medicine, and 594 were on the market as a herbal supplement. Of the 823 herbal products, 522 reports concerned single-herb products, 256 reports concerned combination products, 27 reports concerned vitamin products containing herbal ingredients, and 18 reports concerned product issues. Approximately 15% of reports concerned serious adverse drug reactions, and adulterated products harbored a high risk of causing serious adverse drug reactions.

Conclusions

Analysis of the herbal medicinal products and herbal supplements in the Dutch pharmacovigilance database revealed a variety of suspected herbal ingredients. The reports provide insight into the variety of herbal products used in the Netherlands and the adverse reactions associated with their use. Pharmacovigilance of herbal products is essential to ensure their safe use.

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Author information

Authors and Affiliations

  1. Netherlands Pharmacovigilance Centre Lareb, ’s-Hertogenbosch, The Netherlands

    Florence P. A. M. van Hunsel, Djurre van der Kooi, Sonja van de Koppel & Herman J. Woerdenbag

  2. Department of Pharmaceutical Technology and Biopharmacy, University of Groningen, Groningen, The Netherlands

    Djurre van der Kooi

  3. Dutch Medicines Evaluation Board, Utrecht, The Netherlands

    Burt H. Kroes

Authors
  1. Florence P. A. M. van Hunsel
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  2. Djurre van der Kooi
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  4. Burt H. Kroes
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  5. Herman J. Woerdenbag
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Corresponding author

Correspondence to Florence P. A. M. van Hunsel.

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Funding

No funding was received for the preparation of this study.

Conflict of interest

The authors declare no conflicts of interest that are directly relevant to the content of this study. Florence P.A.M. van Hunsel is a member of the ISoP Special Interest Group on Herbal and Traditional Medicines. This study was presented as a poster at the Annual ISoP Meeting 2021.

Ethics approval

Ethics approval was not needed for this study.

Consent to participate

No approval or consent was needed for this study.

Consent for publication

No approval or consent was needed for this study.

Availability of data and material

The datasets for this manuscript are not publicly available because of the Lareb data-protection policy. Requests to access the datasets should be directed to the first author and will be granted on reasonable request.

Code availability

The SQL statements for the data used in this article are not publicly available because of the Lareb data-protection policy. Requests to access the datasets should be directed to the first author and will be granted on reasonable request.

Author contributions

The original study protocol was designed by all authors. The dataset was established by DK with the help of SK. Data analysis was performed by DK with input from the other authors. The design of the manuscript was determined by all authors. All authors contributed to the final data analysis and to manuscript drafting and revision. All authors approved the final version to be published and agree to be accountable for all aspects of the work.

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van Hunsel, F.P.A.M., van der Kooi, D., van de Koppel, S. et al. Analysis of Reports on Adverse Drug Reactions Related to Herbal Medicinal Products and Herbal Supplements in the Netherlands Received by the National Pharmacovigilance Centre Lareb. Drug Saf 45, 651–661 (2022). https://doi.org/10.1007/s40264-022-01180-5

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