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Spontaneously Reported Adverse Reactions for Herbal Medicinal Products and Natural Remedies in Sweden 2007–15: Report from the Medical Products Agency
BACKGROUND: In relation to the extensive use of herbal medicinal products in self-care, the safety information is limited and there is a need for improvement. This study describes spontaneously reported adverse reactions related to herbal medicinal products and natural remedies in Sweden. OBJECTIVES...
Autores principales: | , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Springer International Publishing
2017
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5457307/ https://www.ncbi.nlm.nih.gov/pubmed/28353157 http://dx.doi.org/10.1007/s40801-017-0104-y |
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author | Svedlund, Erika Larsson, Maria Hägerkvist, Robert |
author_facet | Svedlund, Erika Larsson, Maria Hägerkvist, Robert |
author_sort | Svedlund, Erika |
collection | PubMed |
description | BACKGROUND: In relation to the extensive use of herbal medicinal products in self-care, the safety information is limited and there is a need for improvement. This study describes spontaneously reported adverse reactions related to herbal medicinal products and natural remedies in Sweden. OBJECTIVES: To evaluate the characteristics and frequency of adverse events recorded by the Swedish Medical Products Agency, where herbal medicinal products and natural remedies were suspected as causative agents. METHODS: Adverse drug reactions reported to the Swedish Medical Product Agency during 2007–15 related to approved herbal medicinal products or natural remedies were included and analysed in the retrospective study. Reports had been assessed for causality when they were lodged and only reports that had been assessed as at least possible were included in the study. RESULTS: In total, 116 reports (concerning 259 adverse reactions) related to herbal medicinal products or natural remedies were found in the Swedish national pharmacovigilance database. The active ingredients most frequently suspected during the study period were black cohosh rhizome (15 reports), purple coneflower herb (14 reports) and a combination of extracts of pollen (13 reports). Adverse reactions related to skin and subcutaneous tissue were the most commonly reported reactions. CONCLUSIONS: No previously unknown safety problems have been discovered in the present study. This finding could be explained by a thorough pre-approval assessment of medicinal products and the fact that most herbal preparations in medicinal products have been in clinical use for many years (for traditional herbal medicinal products, the requirements are ≥30 years), i.e. adverse reactions are acknowledged and assessed before approval. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1007/s40801-017-0104-y) contains supplementary material, which is available to authorized users. |
format | Online Article Text |
id | pubmed-5457307 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2017 |
publisher | Springer International Publishing |
record_format | MEDLINE/PubMed |
spelling | pubmed-54573072017-06-16 Spontaneously Reported Adverse Reactions for Herbal Medicinal Products and Natural Remedies in Sweden 2007–15: Report from the Medical Products Agency Svedlund, Erika Larsson, Maria Hägerkvist, Robert Drugs Real World Outcomes Short Communication BACKGROUND: In relation to the extensive use of herbal medicinal products in self-care, the safety information is limited and there is a need for improvement. This study describes spontaneously reported adverse reactions related to herbal medicinal products and natural remedies in Sweden. OBJECTIVES: To evaluate the characteristics and frequency of adverse events recorded by the Swedish Medical Products Agency, where herbal medicinal products and natural remedies were suspected as causative agents. METHODS: Adverse drug reactions reported to the Swedish Medical Product Agency during 2007–15 related to approved herbal medicinal products or natural remedies were included and analysed in the retrospective study. Reports had been assessed for causality when they were lodged and only reports that had been assessed as at least possible were included in the study. RESULTS: In total, 116 reports (concerning 259 adverse reactions) related to herbal medicinal products or natural remedies were found in the Swedish national pharmacovigilance database. The active ingredients most frequently suspected during the study period were black cohosh rhizome (15 reports), purple coneflower herb (14 reports) and a combination of extracts of pollen (13 reports). Adverse reactions related to skin and subcutaneous tissue were the most commonly reported reactions. CONCLUSIONS: No previously unknown safety problems have been discovered in the present study. This finding could be explained by a thorough pre-approval assessment of medicinal products and the fact that most herbal preparations in medicinal products have been in clinical use for many years (for traditional herbal medicinal products, the requirements are ≥30 years), i.e. adverse reactions are acknowledged and assessed before approval. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1007/s40801-017-0104-y) contains supplementary material, which is available to authorized users. Springer International Publishing 2017-03-28 /pmc/articles/PMC5457307/ /pubmed/28353157 http://dx.doi.org/10.1007/s40801-017-0104-y Text en © The Author(s) 2017 Open AccessThis article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License (http://creativecommons.org/licenses/by-nc/4.0/), which permits any noncommercial use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. |
spellingShingle | Short Communication Svedlund, Erika Larsson, Maria Hägerkvist, Robert Spontaneously Reported Adverse Reactions for Herbal Medicinal Products and Natural Remedies in Sweden 2007–15: Report from the Medical Products Agency |
title | Spontaneously Reported Adverse Reactions for Herbal Medicinal Products and Natural Remedies in Sweden 2007–15: Report from the Medical Products Agency |
title_full | Spontaneously Reported Adverse Reactions for Herbal Medicinal Products and Natural Remedies in Sweden 2007–15: Report from the Medical Products Agency |
title_fullStr | Spontaneously Reported Adverse Reactions for Herbal Medicinal Products and Natural Remedies in Sweden 2007–15: Report from the Medical Products Agency |
title_full_unstemmed | Spontaneously Reported Adverse Reactions for Herbal Medicinal Products and Natural Remedies in Sweden 2007–15: Report from the Medical Products Agency |
title_short | Spontaneously Reported Adverse Reactions for Herbal Medicinal Products and Natural Remedies in Sweden 2007–15: Report from the Medical Products Agency |
title_sort | spontaneously reported adverse reactions for herbal medicinal products and natural remedies in sweden 2007–15: report from the medical products agency |
topic | Short Communication |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5457307/ https://www.ncbi.nlm.nih.gov/pubmed/28353157 http://dx.doi.org/10.1007/s40801-017-0104-y |
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