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Adverse drug reactions reported by consumers for nervous system medications in Europe 2007 to 2011

BACKGROUND: Reporting of adverse drug reactions (ADRs) has traditionally been the sole province of healthcare professionals. In the European Union, more countries have allowed consumers to report ADRs directly to the regulatory agencies. The aim of this study was to characterize ADRs reported by Eur...

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Autores principales: Aagaard, Lise, Hansen, Ebba Holme
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2013
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3685574/
https://www.ncbi.nlm.nih.gov/pubmed/23763896
http://dx.doi.org/10.1186/2050-6511-14-30
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author Aagaard, Lise
Hansen, Ebba Holme
author_facet Aagaard, Lise
Hansen, Ebba Holme
author_sort Aagaard, Lise
collection PubMed
description BACKGROUND: Reporting of adverse drug reactions (ADRs) has traditionally been the sole province of healthcare professionals. In the European Union, more countries have allowed consumers to report ADRs directly to the regulatory agencies. The aim of this study was to characterize ADRs reported by European consumer for nervous system medications. METHODS: ADRs reported by consumers for nervous system medications (ATC group N) from 2007 to 2011 and located in the European ADR database, EudraVigilance, were analysed. Data were categorized with respect to age and sex, category and seriousness of reported ADRs and medications. The unit of analysis was one ADR. RESULTS: We located 4766 ADRs reported for nervous system medications, and one half of these were serious including 19 deaths. Less than 5% of ADRs were reported in children. Totally, 58% of ADRs were reported for women, 42% for men. The majority of reported ADRs were of the types “nervous system disorders” (18% of total ADRs) followed by “psychiatric disorders” (18% of total ADRs) and “general disorders” (15% of total ADRs) which also were the system organ classes in which the majority of serious ADRs were found. ADR reports encompassed medicines from the therapeutic groups: antiepileptics (ATC group N03) (36% of total ADRs), parasympathomimetics (ATC group N07) (22% of total ADRs) and antidepressants ATC group N06A (9% of total ADRs). Antiepileptics were the therapeutic group with the highest share of serious ADRs (60%) followed by antidepressants (15%). Many serious ADRs were reported for pregabalin and varenicline. CONCLUSIONS: The majority of ADRs from nervous system mediations reported by consumers that were identified from the EudraVigilance database were serious. The value of consumer reports in pharmacovigilance still remains unclarified.
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spelling pubmed-36855742013-06-19 Adverse drug reactions reported by consumers for nervous system medications in Europe 2007 to 2011 Aagaard, Lise Hansen, Ebba Holme BMC Pharmacol Toxicol Research Article BACKGROUND: Reporting of adverse drug reactions (ADRs) has traditionally been the sole province of healthcare professionals. In the European Union, more countries have allowed consumers to report ADRs directly to the regulatory agencies. The aim of this study was to characterize ADRs reported by European consumer for nervous system medications. METHODS: ADRs reported by consumers for nervous system medications (ATC group N) from 2007 to 2011 and located in the European ADR database, EudraVigilance, were analysed. Data were categorized with respect to age and sex, category and seriousness of reported ADRs and medications. The unit of analysis was one ADR. RESULTS: We located 4766 ADRs reported for nervous system medications, and one half of these were serious including 19 deaths. Less than 5% of ADRs were reported in children. Totally, 58% of ADRs were reported for women, 42% for men. The majority of reported ADRs were of the types “nervous system disorders” (18% of total ADRs) followed by “psychiatric disorders” (18% of total ADRs) and “general disorders” (15% of total ADRs) which also were the system organ classes in which the majority of serious ADRs were found. ADR reports encompassed medicines from the therapeutic groups: antiepileptics (ATC group N03) (36% of total ADRs), parasympathomimetics (ATC group N07) (22% of total ADRs) and antidepressants ATC group N06A (9% of total ADRs). Antiepileptics were the therapeutic group with the highest share of serious ADRs (60%) followed by antidepressants (15%). Many serious ADRs were reported for pregabalin and varenicline. CONCLUSIONS: The majority of ADRs from nervous system mediations reported by consumers that were identified from the EudraVigilance database were serious. The value of consumer reports in pharmacovigilance still remains unclarified. BioMed Central 2013-06-13 /pmc/articles/PMC3685574/ /pubmed/23763896 http://dx.doi.org/10.1186/2050-6511-14-30 Text en Copyright © 2013 Aagaard and Hansen; licensee BioMed Central Ltd. http://www.creativecommons.org/licenses/by/2.0 This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://www.creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Research Article
Aagaard, Lise
Hansen, Ebba Holme
Adverse drug reactions reported by consumers for nervous system medications in Europe 2007 to 2011
title Adverse drug reactions reported by consumers for nervous system medications in Europe 2007 to 2011
title_full Adverse drug reactions reported by consumers for nervous system medications in Europe 2007 to 2011
title_fullStr Adverse drug reactions reported by consumers for nervous system medications in Europe 2007 to 2011
title_full_unstemmed Adverse drug reactions reported by consumers for nervous system medications in Europe 2007 to 2011
title_short Adverse drug reactions reported by consumers for nervous system medications in Europe 2007 to 2011
title_sort adverse drug reactions reported by consumers for nervous system medications in europe 2007 to 2011
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3685574/
https://www.ncbi.nlm.nih.gov/pubmed/23763896
http://dx.doi.org/10.1186/2050-6511-14-30
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