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

Abstract

IntroductionThe 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.

Association of Drinking Herbal Tea with Activities of Daily Living among Elderly: A Latent Class Analysis

“…However, it is worth noting that these teas may also present health hazards. Studies have shown that drinking green tea might cause liver damage [ 54 ], and nutritional supplements mixed with herbal ingredients might also cause kidney toxicity or other adverse drug reactions [ 55 ]. Therefore, before taking herbal supplements and tea products, the possible health hazards should be fully evaluated, especially in vulnerable groups such as pregnant women, the elderly, and children.…”

Safety assessment and adverse drug reaction reporting of tea tree oil (Melaleuca aetheroleum)

“…This can be explained by the assumptions that herbal medicinal products are more frequently used by women, and that women are more apt to report an ADR than men (Stjernberg et al, 2006; Zhang et al, 2015). Moreover, women may be more likely to experience side effects than men, since the dosage in relation to their body weight is relatively higher (Van Hunsel, Van der Kooi, et al, 2022). Noteworthy in the age distribution of ADRs, is that the age group of 2–11 years has a large share for both single and multiple ingredient tea tree oil products.…”