Journal Title
Title of Journal: Drug Saf
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Publisher
Springer International Publishing
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Authors: Jitka Pokladnikova Ronald H B Meyboom Ricarda Meincke David Niedrig Stefan Russmann
Publish Date: 2016/03/02
Volume: 39, Issue: 5, Pages: 455-464
Abstract
Herbal medicines are used worldwide and with an increasing popularity in Western countries Although often perceived as ‘naturally safe’ herbals may cause severe adverse drug reactions ADRs with immediate allergic reactions being particularly life threateningThe documentation of all suspected ADRs in association with herbal exposure reported to VigiBase® from 1969 to August 2014 was retrieved Among all reports in which WHOART reaction terms were indicative of acute allergic reactions those classified as ‘suspect’ with a documented causality assessment and latency time of ≤1 day were selected For the most frequent specific herbal–ADR combinations the information component IC as a measure of disproportionality based on Bayesian statistics was calculatedWe identified 757 reports out of 1039 ADRs Products with mixed herbals 360 as well as those administered orally 632 were predominant The most frequent reactions were urticaria and rash 492 Anaphylactic reactions accounted for 95 Disproportionally frequent reporting of mouth edema IC = 181 and anaphylactic reactions IC = 124 to Phleum pretense were notedOur findings indicate that herbal medicines for oral use carry a risk of causing immediate allergylike ADRs Studies using the Vigibase® database can identify specific combinations of particular herbs and adverse reactions Healthcare professionals and patients should be aware of these risks and report any serious adverse experiencesWe would like to thank Niklas Norén PhD Chief Science Officer and other colleagues at the UMC especially Marie Lindguist MSc PhD Hon FRCP Pia CaduffJanosa MD Anders Viklund MSc Pharm Monica Ploën BSc Pharm and Mohamed Farah Pharm D for their support as well as the WHO National Pharmacovigilance Centers for providing additional information
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