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Adverse Drug Reactions Relevant to Drug Resistance and Ineffectiveness Associated with Meropenem, Linezolid, and Colistin: An Analysis Based on Spontaneous Reports from the European Pharmacovigilance Database

Antimicrobial resistance is considered one of the major threats to public health and is an important factor that influences the patient’s outcome in the intensive care unit. Pharmacovigilance can help raise awareness of potential drug resistance (DR) or ineffectiveness (DI) through adverse drug reac...

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Autores principales: Vintila, Bogdan Ioan, Arseniu, Anca Maria, Butuca, Anca, Sava, Mihai, Bîrluțiu, Victoria, Rus, Luca Liviu, Axente, Dan Damian, Morgovan, Claudiu, Gligor, Felicia Gabriela
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10215571/
https://www.ncbi.nlm.nih.gov/pubmed/37237821
http://dx.doi.org/10.3390/antibiotics12050918
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author Vintila, Bogdan Ioan
Arseniu, Anca Maria
Butuca, Anca
Sava, Mihai
Bîrluțiu, Victoria
Rus, Luca Liviu
Axente, Dan Damian
Morgovan, Claudiu
Gligor, Felicia Gabriela
author_facet Vintila, Bogdan Ioan
Arseniu, Anca Maria
Butuca, Anca
Sava, Mihai
Bîrluțiu, Victoria
Rus, Luca Liviu
Axente, Dan Damian
Morgovan, Claudiu
Gligor, Felicia Gabriela
author_sort Vintila, Bogdan Ioan
collection PubMed
description Antimicrobial resistance is considered one of the major threats to public health and is an important factor that influences the patient’s outcome in the intensive care unit. Pharmacovigilance can help raise awareness of potential drug resistance (DR) or ineffectiveness (DI) through adverse drug reaction reports that are submitted to different spontaneous reporting systems. Based on spontaneous Individual Case Safety Reports from EudraVigilance, we conducted a descriptive analysis of adverse drug reactions associated with meropenem, colistin, and linezolid, with a focus on DR and DI. Of the total adverse drug reactions (ADRs) reported for each analyzed antibiotic by 31 December 2022, between 2.38–8.42% and 4.15–10.14% of the reports were related to DR and DI, respectively. A disproportionality analysis was conducted to evaluate the frequency of reporting adverse drug reactions relevant to the DR and DI of the analyzed antibiotics compared to other antimicrobials. Based on the analysis of the collected data, this study underlines the importance of post-marketing drug safety monitoring in raising a warning signal regarding antimicrobial resistance, thereby potentially contributing to the reduction in antibiotic treatment failure in an intensive care setting.
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spelling pubmed-102155712023-05-27 Adverse Drug Reactions Relevant to Drug Resistance and Ineffectiveness Associated with Meropenem, Linezolid, and Colistin: An Analysis Based on Spontaneous Reports from the European Pharmacovigilance Database Vintila, Bogdan Ioan Arseniu, Anca Maria Butuca, Anca Sava, Mihai Bîrluțiu, Victoria Rus, Luca Liviu Axente, Dan Damian Morgovan, Claudiu Gligor, Felicia Gabriela Antibiotics (Basel) Article Antimicrobial resistance is considered one of the major threats to public health and is an important factor that influences the patient’s outcome in the intensive care unit. Pharmacovigilance can help raise awareness of potential drug resistance (DR) or ineffectiveness (DI) through adverse drug reaction reports that are submitted to different spontaneous reporting systems. Based on spontaneous Individual Case Safety Reports from EudraVigilance, we conducted a descriptive analysis of adverse drug reactions associated with meropenem, colistin, and linezolid, with a focus on DR and DI. Of the total adverse drug reactions (ADRs) reported for each analyzed antibiotic by 31 December 2022, between 2.38–8.42% and 4.15–10.14% of the reports were related to DR and DI, respectively. A disproportionality analysis was conducted to evaluate the frequency of reporting adverse drug reactions relevant to the DR and DI of the analyzed antibiotics compared to other antimicrobials. Based on the analysis of the collected data, this study underlines the importance of post-marketing drug safety monitoring in raising a warning signal regarding antimicrobial resistance, thereby potentially contributing to the reduction in antibiotic treatment failure in an intensive care setting. MDPI 2023-05-16 /pmc/articles/PMC10215571/ /pubmed/37237821 http://dx.doi.org/10.3390/antibiotics12050918 Text en © 2023 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
Vintila, Bogdan Ioan
Arseniu, Anca Maria
Butuca, Anca
Sava, Mihai
Bîrluțiu, Victoria
Rus, Luca Liviu
Axente, Dan Damian
Morgovan, Claudiu
Gligor, Felicia Gabriela
Adverse Drug Reactions Relevant to Drug Resistance and Ineffectiveness Associated with Meropenem, Linezolid, and Colistin: An Analysis Based on Spontaneous Reports from the European Pharmacovigilance Database
title Adverse Drug Reactions Relevant to Drug Resistance and Ineffectiveness Associated with Meropenem, Linezolid, and Colistin: An Analysis Based on Spontaneous Reports from the European Pharmacovigilance Database
title_full Adverse Drug Reactions Relevant to Drug Resistance and Ineffectiveness Associated with Meropenem, Linezolid, and Colistin: An Analysis Based on Spontaneous Reports from the European Pharmacovigilance Database
title_fullStr Adverse Drug Reactions Relevant to Drug Resistance and Ineffectiveness Associated with Meropenem, Linezolid, and Colistin: An Analysis Based on Spontaneous Reports from the European Pharmacovigilance Database
title_full_unstemmed Adverse Drug Reactions Relevant to Drug Resistance and Ineffectiveness Associated with Meropenem, Linezolid, and Colistin: An Analysis Based on Spontaneous Reports from the European Pharmacovigilance Database
title_short Adverse Drug Reactions Relevant to Drug Resistance and Ineffectiveness Associated with Meropenem, Linezolid, and Colistin: An Analysis Based on Spontaneous Reports from the European Pharmacovigilance Database
title_sort adverse drug reactions relevant to drug resistance and ineffectiveness associated with meropenem, linezolid, and colistin: an analysis based on spontaneous reports from the european pharmacovigilance database
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10215571/
https://www.ncbi.nlm.nih.gov/pubmed/37237821
http://dx.doi.org/10.3390/antibiotics12050918
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