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Causality Assessment of Olfactory and Gustatory Dysfunction Associated with Intranasal Fluticasone Propionate: Application of the Bradford Hill Criteria
Causality assessment is crucial to post-marketing pharmacovigilance and helps optimize safe and appropriate use of medicines by patients in the real world. Self-reported olfactory and gustatory dysfunction are common in the general population as well as in patients with allergic rhinitis and nasal p...
Autores principales: | , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Springer Healthcare
2018
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5818548/ https://www.ncbi.nlm.nih.gov/pubmed/29396682 http://dx.doi.org/10.1007/s12325-018-0665-5 |
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author | Muganurmath, Chandrashekhar S. Curry, Amy L. Schindzielorz, Andrew H. |
author_facet | Muganurmath, Chandrashekhar S. Curry, Amy L. Schindzielorz, Andrew H. |
author_sort | Muganurmath, Chandrashekhar S. |
collection | PubMed |
description | Causality assessment is crucial to post-marketing pharmacovigilance and helps optimize safe and appropriate use of medicines by patients in the real world. Self-reported olfactory and gustatory dysfunction are common in the general population as well as in patients with allergic rhinitis and nasal polyposis. Intranasal corticosteroids, including intranasal fluticasone propionate (INFP), are amongst the most effective drugs indicated in the treatment of allergic rhinitis and nasal polyposis. While intranasal corticosteroids are associated with olfactory and gustatory dysfunction and are currently labeled for these adverse events, causality assessment has not been performed to date. Although there is no single widely accepted method to assess causality in pharmacovigilance, the Bradford Hill criteria offer a robust and comprehensive approach because nine distinct aspects of an observed potential drug–event association are assessed. In this literature-based narrative review, Hill’s criteria were applied to determine causal inference between INFP and olfactory and gustatory dysfunction. |
format | Online Article Text |
id | pubmed-5818548 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2018 |
publisher | Springer Healthcare |
record_format | MEDLINE/PubMed |
spelling | pubmed-58185482018-02-27 Causality Assessment of Olfactory and Gustatory Dysfunction Associated with Intranasal Fluticasone Propionate: Application of the Bradford Hill Criteria Muganurmath, Chandrashekhar S. Curry, Amy L. Schindzielorz, Andrew H. Adv Ther Review Causality assessment is crucial to post-marketing pharmacovigilance and helps optimize safe and appropriate use of medicines by patients in the real world. Self-reported olfactory and gustatory dysfunction are common in the general population as well as in patients with allergic rhinitis and nasal polyposis. Intranasal corticosteroids, including intranasal fluticasone propionate (INFP), are amongst the most effective drugs indicated in the treatment of allergic rhinitis and nasal polyposis. While intranasal corticosteroids are associated with olfactory and gustatory dysfunction and are currently labeled for these adverse events, causality assessment has not been performed to date. Although there is no single widely accepted method to assess causality in pharmacovigilance, the Bradford Hill criteria offer a robust and comprehensive approach because nine distinct aspects of an observed potential drug–event association are assessed. In this literature-based narrative review, Hill’s criteria were applied to determine causal inference between INFP and olfactory and gustatory dysfunction. Springer Healthcare 2018-02-02 2018 /pmc/articles/PMC5818548/ /pubmed/29396682 http://dx.doi.org/10.1007/s12325-018-0665-5 Text en © The Author(s) 2018 https://creativecommons.org/licenses/by-nc/4.0/This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License (http://creativecommons.org/licenses/by-nc/4.0/ (https://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 | Review Muganurmath, Chandrashekhar S. Curry, Amy L. Schindzielorz, Andrew H. Causality Assessment of Olfactory and Gustatory Dysfunction Associated with Intranasal Fluticasone Propionate: Application of the Bradford Hill Criteria |
title | Causality Assessment of Olfactory and Gustatory Dysfunction Associated with Intranasal Fluticasone Propionate: Application of the Bradford Hill Criteria |
title_full | Causality Assessment of Olfactory and Gustatory Dysfunction Associated with Intranasal Fluticasone Propionate: Application of the Bradford Hill Criteria |
title_fullStr | Causality Assessment of Olfactory and Gustatory Dysfunction Associated with Intranasal Fluticasone Propionate: Application of the Bradford Hill Criteria |
title_full_unstemmed | Causality Assessment of Olfactory and Gustatory Dysfunction Associated with Intranasal Fluticasone Propionate: Application of the Bradford Hill Criteria |
title_short | Causality Assessment of Olfactory and Gustatory Dysfunction Associated with Intranasal Fluticasone Propionate: Application of the Bradford Hill Criteria |
title_sort | causality assessment of olfactory and gustatory dysfunction associated with intranasal fluticasone propionate: application of the bradford hill criteria |
topic | Review |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5818548/ https://www.ncbi.nlm.nih.gov/pubmed/29396682 http://dx.doi.org/10.1007/s12325-018-0665-5 |
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