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New study: Safety of Anthroposophic Medicinal Products

25 Aug 2021

A new study provides another important dataset analysis to further confirm the high safety profile of anthroposophic medicinal products.

The study, ‘Safety of Anthroposophic Medicinal Products: An Analysis of Adverse Drug Reactions from German Pharmacovigilance Databases’, published in July 2021 as an Open Access document, finds that adverse drug reactions (ADRs) from anthroposophic medicinal products were “very rare and, as in previously published studies, mostly reversible and non-serious in nature”.

This was a retrolective study, the objective of which was to determine the frequency of reported ADRs from all anthroposophic medicinal products on the market, in absolute numbers and relative to the maximum daily administration doses. The researchers carried out an analysis of ADRs in pharmacovigilance databases of four Marketing Authorisation Holders for anthroposophic medicinal products in Germany. The dataset covered over 99% of all anthroposophic medicinal products marketed in Germany from 2010 to 2017. Retrolective analysis of pharmacovigilance data from spontaneous reporting systems is an important method to investigate and monitor the safety of anthroposophic medicinal products therapy in everyday practice.

In the period 2010–2017, a total of 5506 ADRs were reported that had occurred in 2765 different patients, comprising 370 different anthroposophic medicinal products. The frequency of ADRs for all anthroposophic medicinal products was 1.5 per million maximum daily administration doses. Less than 2% of ADRs were classified as serious. The frequency of serious ADRs was 0.03 per million. ADRs were more frequently reported with injections than with oral or local administration. At least two-thirds of ADRs were resolved upon reporting, and there were no reports of ADRs related to anthroposophic medicinal product with a fatal outcome.

Further information

Jong, M.C., van Wietmarschen, H., Glockmann, A. et al. Safety of Anthroposophic Medicinal Products: An Analysis of Adverse Drug Reactions from German Pharmacovigilance Databases. Drugs - Real World Outcomes (2021). https://doi.org/10.1007/s40801-021-00262-7

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