Reporting of adverse reactions from plant-based products in Norway from 2003 to 2012

Purpose

Since 2003 the Regional Medicines Information and Pharmacovigilance centre (RELIS) has handled reports on adverse reactions from medicines and dietary supplements from health care professionals. This is the first review of the data concerning the plant-based products, and highlights the trends related to the reporting frequency, categories of health care professionals that are reporting, the side effects most frequently reported, the severity of the reactions and patient characteristics.

Materials and methods

The data includes all reports of plant-based products in the Norwegian safety database from 2003 to 2012.

Fig. 1: Characteristics of adverse event reports for plant-based products for the period 2003 – 2012 in the Norwegian database for adverse drug reactions.

Results and conclusion

Since 2003 RELIS has received 260 reports on adverse reactions associated with plant-based products. Of these, 96% concern plant-based dietary supplements. Of the 10 reports on plant-based medicines, all were reported by pharmacists, and none were classified as severe. In the last three years, the reporting rate has decreased. In 2012, pharmacists did not report any adverse reactions from plant-based products. Hypersensitivity reactions, hepatic events and interactions with anticoagulants are the most commonly reported adverse effects for plant-based products (Fig. 1). Increased focus on adverse reactions reporting can generate important knowledge about such products.