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Descriptive Analysis of Adverse Drug Reactions Reports of the Most Consumed Antibiotics in Portugal, Prescribed for Upper Airway Infections

Adverse drug reactions (ADR) significantly impact mortality and morbidity and lead to high healthcare costs. Reporting ADR to regulatory authorities allows for monitoring the safety and efficacy profile of medicines on the market and for assessing the benefit–risk ratio. This retrospective study aim...

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Autores principales: Ferreira, Joana, Placido, Ana Isabel, Afreixo, Vera, Ribeiro-Vaz, Inês, Roque, Fátima, Herdeiro, Maria Teresa
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9028170/
https://www.ncbi.nlm.nih.gov/pubmed/35453228
http://dx.doi.org/10.3390/antibiotics11040477
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author Ferreira, Joana
Placido, Ana Isabel
Afreixo, Vera
Ribeiro-Vaz, Inês
Roque, Fátima
Herdeiro, Maria Teresa
author_facet Ferreira, Joana
Placido, Ana Isabel
Afreixo, Vera
Ribeiro-Vaz, Inês
Roque, Fátima
Herdeiro, Maria Teresa
author_sort Ferreira, Joana
collection PubMed
description Adverse drug reactions (ADR) significantly impact mortality and morbidity and lead to high healthcare costs. Reporting ADR to regulatory authorities allows for monitoring the safety and efficacy profile of medicines on the market and for assessing the benefit–risk ratio. This retrospective study aims to characterize the ADR profile of the most consumed antibiotics in Portugal that are prescribed for upper airway infections and submitted to the EudraVigilance database. The variables were analyzed in an exploratory perspective, through absolute and relative frequencies, with emphasis on serious ADR. A total of 59,022 reports were analyzed of which 64.4% were classified as suspected serious ADR. According to serious ADR, the female sex (52.2%) and 18–64 age group (47.5%) prevail. Health professionals reported 87.8% of suspected serious ADR and European Economic Area (EEA) countries represented 50.8% of the reports. “Skin and subcutaneous tissue connections” (15.9%), “general disorders and administrations site conditions” (12%), and “gastrointestinal disorders” (9.8%) are the prevalent system organ classes. In 4.5% of the reports, patients had a fatal outcome. A periodic evaluation of the safety of the antibiotic should be performed to facilitate the development of guidelines and policies to reduce the frequency of serious ADR.
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spelling pubmed-90281702022-04-23 Descriptive Analysis of Adverse Drug Reactions Reports of the Most Consumed Antibiotics in Portugal, Prescribed for Upper Airway Infections Ferreira, Joana Placido, Ana Isabel Afreixo, Vera Ribeiro-Vaz, Inês Roque, Fátima Herdeiro, Maria Teresa Antibiotics (Basel) Article Adverse drug reactions (ADR) significantly impact mortality and morbidity and lead to high healthcare costs. Reporting ADR to regulatory authorities allows for monitoring the safety and efficacy profile of medicines on the market and for assessing the benefit–risk ratio. This retrospective study aims to characterize the ADR profile of the most consumed antibiotics in Portugal that are prescribed for upper airway infections and submitted to the EudraVigilance database. The variables were analyzed in an exploratory perspective, through absolute and relative frequencies, with emphasis on serious ADR. A total of 59,022 reports were analyzed of which 64.4% were classified as suspected serious ADR. According to serious ADR, the female sex (52.2%) and 18–64 age group (47.5%) prevail. Health professionals reported 87.8% of suspected serious ADR and European Economic Area (EEA) countries represented 50.8% of the reports. “Skin and subcutaneous tissue connections” (15.9%), “general disorders and administrations site conditions” (12%), and “gastrointestinal disorders” (9.8%) are the prevalent system organ classes. In 4.5% of the reports, patients had a fatal outcome. A periodic evaluation of the safety of the antibiotic should be performed to facilitate the development of guidelines and policies to reduce the frequency of serious ADR. MDPI 2022-04-02 /pmc/articles/PMC9028170/ /pubmed/35453228 http://dx.doi.org/10.3390/antibiotics11040477 Text en © 2022 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Ferreira, Joana
Placido, Ana Isabel
Afreixo, Vera
Ribeiro-Vaz, Inês
Roque, Fátima
Herdeiro, Maria Teresa
Descriptive Analysis of Adverse Drug Reactions Reports of the Most Consumed Antibiotics in Portugal, Prescribed for Upper Airway Infections
title Descriptive Analysis of Adverse Drug Reactions Reports of the Most Consumed Antibiotics in Portugal, Prescribed for Upper Airway Infections
title_full Descriptive Analysis of Adverse Drug Reactions Reports of the Most Consumed Antibiotics in Portugal, Prescribed for Upper Airway Infections
title_fullStr Descriptive Analysis of Adverse Drug Reactions Reports of the Most Consumed Antibiotics in Portugal, Prescribed for Upper Airway Infections
title_full_unstemmed Descriptive Analysis of Adverse Drug Reactions Reports of the Most Consumed Antibiotics in Portugal, Prescribed for Upper Airway Infections
title_short Descriptive Analysis of Adverse Drug Reactions Reports of the Most Consumed Antibiotics in Portugal, Prescribed for Upper Airway Infections
title_sort descriptive analysis of adverse drug reactions reports of the most consumed antibiotics in portugal, prescribed for upper airway infections
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9028170/
https://www.ncbi.nlm.nih.gov/pubmed/35453228
http://dx.doi.org/10.3390/antibiotics11040477
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