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Adverse drug reactions to anthroposophic and homeopathic solutions for injection: a systematic evaluation of German pharmacovigilance databases
Mid Sweden University, Faculty of Human Sciences, Department of Health Sciences.
Mid Sweden University, Faculty of Human Sciences, Department of Health Sciences.ORCID iD: 0000-0002-3907-2197
Louis Bolk Institute, Dep Health & Nutrition.
2012 (English)In: Pharmacoepidemiology and Drug Safety, ISSN 1053-8569, E-ISSN 1099-1557, Vol. 21, no 12, 1295-1301 p.Article in journal (Refereed) Published
Abstract [en]

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 angioedema, 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

Place, publisher, year, edition, pages
2012. Vol. 21, no 12, 1295-1301 p.
Keyword [en]
Adverse drug reactions; Anthroposophy; Homeopathy; Pharmacoepidemiology; Pharmacovigilance; Solutions for injection
National Category
Medical and Health Sciences
Identifiers
URN: urn:nbn:se:miun:diva-15497DOI: 10.1002/pds.3298ISI: 000312146900006Scopus ID: 2-s2.0-84870682349OAI: oai:DiVA.org:miun-15497DiVA: diva2:467990
Available from: 2011-12-20 Created: 2011-12-20 Last updated: 2014-08-31Bibliographically approved

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Citation style
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