Safety of Anthroposophic Medicinal Products: An Analysis of Adverse Drug Reactions from German Pharmacovigilance Databases.

ABSTRACT:

Background

Anthroposophic medicinal products (AMPs) are widely used in Europe and world-wide.

Objective

To determine the frequency of reported adverse drug reactions (ADRs) from all AMPs on the market, in absolute numbers and relative to the maximum daily administration doses (MDADs).

Patients and methods

Retrolective safety analysis of AMP-related ADRs in pharmacovigilance databases of four AMP Marketing Authorisation Holders in Germany. For each ADR, information about the patient, outcome, causality and AMP was retrieved. Primary outcome was the frequency of reported ADRs relative to MDADs sold.

Results

In the period 2010-2017, a total of 5506 ADRs were reported that had occurred in 2765 different patients, comprising 370 different AMPs. A total of 104 ADRs (

SUBMITTER: Jong MC 

PROVIDER: S-EPMC8605942 | biostudies-literature | 2021 Dec

REPOSITORIES: biostudies-literature