Reports of Symptoms Associated with Supraventricular Arrhythmias as a Serious Adverse Drug Reaction in the Spanish Pharmacovigilance Database

This study aimed to determine the type of drugs reported as suspected of causing severe supraventricular arrhythmias from the Spanish Human Pharmacovigilance System database. A total of 1053 reports were analysed, of which 526 (50%) were on men and 516 (49%) were on women. The most affected age grou...

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Autores principales: Pueyo-Val, Javier, Avedillo-Salas, Ana, Berdún-Viñegra, Pablo, Pueyo-Val, Olga María, Fanlo-Villacampa, Ana, Navarro-Pemán, Cristina, Lanuza-Giménez, Francisco Javier, Ioakeim-Skoufa, Ignatios, Vicente-Romero, Jorge
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10457936/
https://www.ncbi.nlm.nih.gov/pubmed/37631076
http://dx.doi.org/10.3390/ph16081161
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author Pueyo-Val, Javier
Avedillo-Salas, Ana
Berdún-Viñegra, Pablo
Pueyo-Val, Olga María
Fanlo-Villacampa, Ana
Navarro-Pemán, Cristina
Lanuza-Giménez, Francisco Javier
Ioakeim-Skoufa, Ignatios
Vicente-Romero, Jorge
author_facet Pueyo-Val, Javier
Avedillo-Salas, Ana
Berdún-Viñegra, Pablo
Pueyo-Val, Olga María
Fanlo-Villacampa, Ana
Navarro-Pemán, Cristina
Lanuza-Giménez, Francisco Javier
Ioakeim-Skoufa, Ignatios
Vicente-Romero, Jorge
author_sort Pueyo-Val, Javier
collection PubMed
description This study aimed to determine the type of drugs reported as suspected of causing severe supraventricular arrhythmias from the Spanish Human Pharmacovigilance System database. A total of 1053 reports were analysed, of which 526 (50%) were on men and 516 (49%) were on women. The most affected age group was the over-65s, with 593 reports (56%). Of the 1613 drugs, those belonging to the cardiovascular system (ATC Group C) were the most numerous (414 reports, 26%), with digoxin being the most frequent drug (49 reports, 12%). Other common groups were antiinfectives for systemic use (ATC Group J; 306 reports, 19%), antineoplastic and immunomodulating agents (ATC Group L; 198 reports, 12%), and nervous system drugs (ATC Group N; 185 reports, 11%). The most common supraventricular arrhythmia was atrial fibrillation (561 reports, 51%). Regarding outcomes, 730 (66%) patients recovered, 76 (7%) did not recover, 25 (3%) recovered but with sequelae, and 23 (2%) resulted in death. This study revealed that certain drugs have reported to be associated more frequently to supraventricular arrhythmias as serious adverse reactions, especially in the older population. Proper clinical management and effective strategies to ensure medication appropriateness should always be considered to improve patient safety when prescribing drugs.
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spelling pubmed-104579362023-08-27 Reports of Symptoms Associated with Supraventricular Arrhythmias as a Serious Adverse Drug Reaction in the Spanish Pharmacovigilance Database Pueyo-Val, Javier Avedillo-Salas, Ana Berdún-Viñegra, Pablo Pueyo-Val, Olga María Fanlo-Villacampa, Ana Navarro-Pemán, Cristina Lanuza-Giménez, Francisco Javier Ioakeim-Skoufa, Ignatios Vicente-Romero, Jorge Pharmaceuticals (Basel) Article This study aimed to determine the type of drugs reported as suspected of causing severe supraventricular arrhythmias from the Spanish Human Pharmacovigilance System database. A total of 1053 reports were analysed, of which 526 (50%) were on men and 516 (49%) were on women. The most affected age group was the over-65s, with 593 reports (56%). Of the 1613 drugs, those belonging to the cardiovascular system (ATC Group C) were the most numerous (414 reports, 26%), with digoxin being the most frequent drug (49 reports, 12%). Other common groups were antiinfectives for systemic use (ATC Group J; 306 reports, 19%), antineoplastic and immunomodulating agents (ATC Group L; 198 reports, 12%), and nervous system drugs (ATC Group N; 185 reports, 11%). The most common supraventricular arrhythmia was atrial fibrillation (561 reports, 51%). Regarding outcomes, 730 (66%) patients recovered, 76 (7%) did not recover, 25 (3%) recovered but with sequelae, and 23 (2%) resulted in death. This study revealed that certain drugs have reported to be associated more frequently to supraventricular arrhythmias as serious adverse reactions, especially in the older population. Proper clinical management and effective strategies to ensure medication appropriateness should always be considered to improve patient safety when prescribing drugs. MDPI 2023-08-15 /pmc/articles/PMC10457936/ /pubmed/37631076 http://dx.doi.org/10.3390/ph16081161 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
Pueyo-Val, Javier
Avedillo-Salas, Ana
Berdún-Viñegra, Pablo
Pueyo-Val, Olga María
Fanlo-Villacampa, Ana
Navarro-Pemán, Cristina
Lanuza-Giménez, Francisco Javier
Ioakeim-Skoufa, Ignatios
Vicente-Romero, Jorge
Reports of Symptoms Associated with Supraventricular Arrhythmias as a Serious Adverse Drug Reaction in the Spanish Pharmacovigilance Database
title Reports of Symptoms Associated with Supraventricular Arrhythmias as a Serious Adverse Drug Reaction in the Spanish Pharmacovigilance Database
title_full Reports of Symptoms Associated with Supraventricular Arrhythmias as a Serious Adverse Drug Reaction in the Spanish Pharmacovigilance Database
title_fullStr Reports of Symptoms Associated with Supraventricular Arrhythmias as a Serious Adverse Drug Reaction in the Spanish Pharmacovigilance Database
title_full_unstemmed Reports of Symptoms Associated with Supraventricular Arrhythmias as a Serious Adverse Drug Reaction in the Spanish Pharmacovigilance Database
title_short Reports of Symptoms Associated with Supraventricular Arrhythmias as a Serious Adverse Drug Reaction in the Spanish Pharmacovigilance Database
title_sort reports of symptoms associated with supraventricular arrhythmias as a serious adverse drug reaction in the spanish pharmacovigilance database
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10457936/
https://www.ncbi.nlm.nih.gov/pubmed/37631076
http://dx.doi.org/10.3390/ph16081161
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