ORIGINAL REPORT Adverse drug reactions to anthroposophic and homeopathic solutions for injection: a systematic evaluation of German pharmacovigilance databases Miek C. Jong 1,2 *, Mats U. Jong 2 and Erik W. Baars 1 1 Department Healthcare and Nutrition, Louis Bolk Institute, Driebergen, The Netherlands 2 Department Health Sciences, Mid Sweden University, Sundsvall, Sweden ABSTRACT Purpose Medicinal solutions for injection are frequently applied in anthroposophic medicine and homeopathy. Despite their extensive use, there is little data published on the safety of these products. Therefore, we investigated the safety of anthroposophic and homeopathic solutions for injection through a systematic evaluation of adverse drug reactions (ADRs). Methods ADRs were extracted from the pharmacovigilance databases of eight German manufacturers. Analysed ADRs included case reports in humans only, (spontaneous) case reports from post-marketing surveillance, literature and clinical/safety trials. Results Between 2000 and 2009, in total, 303 million ampoules for injection were sold, and 486 case reports were identified, corresponding to a total number of 1180 ADRs. Of all case reports, 71.8% (349/486) included ADRs that were listed (e.g. stated in package leaflet), and 9.5% (46/486) of the reports were classified as serious. The most frequently reported ADRs were pruritus, followed by angioe- dema, diarrhoea and erythema. A total of 27.3% (322/1180) were localized reactions for example; application or injection site erythema, pain, swelling and inflammation. The overall reporting rate of ADRs associated with injections was less than 4 per 1 million sold ampoules and classified as very rare. Conclusions Our systematic evaluation demonstrated that the reporting rate of ADRs associated with anthroposophic and homeopathic solutions for injection is very low. Most reported ADRs were listed, and one quarter consisted of local reactions. These findings suggest a low risk profile for solutions for injection as therapeutically applied in anthroposophic medicine and homeopathy. Copyright © 2012 John Wiley & Sons, Ltd. key words—pharmacovigilance; adverse drug reactions; solutions for injection; homeopathy; anthroposophy; pharmacoepidemiology Received 5 July 2011; Revised 16 April 2012; Accepted 24 April 2012 INTRODUCTION Medicinal solutions for injection, manufactured in accordance with the German Homoeopathic Pharma- copoeia, 1 are therapeutically applied in homeopathy and anthroposophic medicine for a wide range of conditions. Homeopathy was developed more than 200 years ago by Samuel Hahnemann. It is based on the principles of similars, meaning that a disease can be cured by a substance that produces similar symp- toms in healthy people. The therapeutic use of paren- teral administration forms in homeopathy was first described in the 19 th century. 2 Anthroposophic medicine is a system of medicine based on the spiritual science that was developed by Rudolf Steiner and Ita Wegman. In 1923/24, Steiner 3,4 recommended injec- tions as one of the main routes of administration for anthroposophic medication. Nowadays, more than 90 million medicinal ampoules are sold per year world- wide. German anthroposophic and homeopathic man- ufacturers produce over 90% of these ampoules. 5 Previous studies have shown that anthroposophic and homeopathic practitioners often favor the paren- teral dosage form as their first choice in the treatment of acute and chronic diseases. 6,7 Reasons for this pref- erence are the anticipated better clinical effect of injec- tions, the possibility to control compliance and that the exact location of administration can be chosen. Other *Correspondence to: M. C. Jong, Louis Bolk Institute, Department Healthcare & Nutrition, Hoofdstraat 24, 3972 LA Driebergen, The Netherlands. E-mail: m.jong@louisbolk.nl Copyright © 2012 John Wiley & Sons, Ltd. pharmacoepidemiology and drug safety (2012) Published online in Wiley Online Library (wileyonlinelibrary.com) DOI: 10.1002/pds.3298