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Spontaneous Reports of Serious Adverse Drug Reactions Resulting From Drug–Drug Interactions: An Analysis From the French Pharmacovigilance Database

Few data are available on the clinical impact of drug–drug interactions (DDIs). Most of the studies are limited to the analysis of exposure to potential DDI or the targeted impact of the combination of a few drugs or therapeutic classes. The analysis of adverse drug reaction (ADR) reports could be a...

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Autores principales: Létinier, Louis, Ferreira, Amandine, Marceron, Alexandre, Babin, Marina, Micallef, Joëlle, Miremont-Salamé, Ghada, Pariente, Antoine
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8024557/
https://www.ncbi.nlm.nih.gov/pubmed/33841134
http://dx.doi.org/10.3389/fphar.2020.624562
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author Létinier, Louis
Ferreira, Amandine
Marceron, Alexandre
Babin, Marina
Micallef, Joëlle
Miremont-Salamé, Ghada
Pariente, Antoine
author_facet Létinier, Louis
Ferreira, Amandine
Marceron, Alexandre
Babin, Marina
Micallef, Joëlle
Miremont-Salamé, Ghada
Pariente, Antoine
author_sort Létinier, Louis
collection PubMed
description Few data are available on the clinical impact of drug–drug interactions (DDIs). Most of the studies are limited to the analysis of exposure to potential DDI or the targeted impact of the combination of a few drugs or therapeutic classes. The analysis of adverse drug reaction (ADR) reports could be a mean to study generally the adverse effects identified due to a DDI. Our objective was to describe the characteristics of ADRs resulting from DDIs reported to the French Pharmacovigilance system and to identify the drugs most often implicated in these ADRs. Considering all ADR reports from January 01, 2012, to December 31, 2016, we identified all cases of ADR resulting from a DDI (DDI-ADRs). We then described these in terms of patients’ characteristics, ADR seriousness, drugs involved (two or more per case), and ADR type. Of the 4,027 reports relating to DDI-ADRs, 3,303 were related to serious ADRs. Patients with serious DDI-ADRs had a median age of 76 years (interquartile range: 63–84); 53% were male. Of all serious DDI-ADRs, 11% were life-threatening and 8% fatal. In 36% of cases, the DDI causing the ADR involved at least three drugs. Overall, 8,424 different drugs were mentioned in the 3,303 serious DDI-ADRs considered. Altogether, drugs from the “antithrombotic agents” subgroup were incriminated in 34% of serious DDI-ADRs. Antidepressants were the second most represented therapeutic/pharmacological subgroup (5% of serious DDI-ADRs). Among the 3,843 ADR types reported in the 3,303 serious DDI-ADRs considered, the most frequently represented were hemorrhage (40% clinical hemorrhage; 6% biological hemorrhage), renal failure (8%), pharmacokinetic alteration (5%), and cardiac arrhythmias (4%). Hemorrhagic accidents are still an important part of serious ADRs resulting from DDIs reported in France. The other clinical consequences of DDIs seem less well identified by pharmacovigilance. Moreover, more than one-third of serious DDI-ADRs involved at least three drugs.
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spelling pubmed-80245572021-04-08 Spontaneous Reports of Serious Adverse Drug Reactions Resulting From Drug–Drug Interactions: An Analysis From the French Pharmacovigilance Database Létinier, Louis Ferreira, Amandine Marceron, Alexandre Babin, Marina Micallef, Joëlle Miremont-Salamé, Ghada Pariente, Antoine Front Pharmacol Pharmacology Few data are available on the clinical impact of drug–drug interactions (DDIs). Most of the studies are limited to the analysis of exposure to potential DDI or the targeted impact of the combination of a few drugs or therapeutic classes. The analysis of adverse drug reaction (ADR) reports could be a mean to study generally the adverse effects identified due to a DDI. Our objective was to describe the characteristics of ADRs resulting from DDIs reported to the French Pharmacovigilance system and to identify the drugs most often implicated in these ADRs. Considering all ADR reports from January 01, 2012, to December 31, 2016, we identified all cases of ADR resulting from a DDI (DDI-ADRs). We then described these in terms of patients’ characteristics, ADR seriousness, drugs involved (two or more per case), and ADR type. Of the 4,027 reports relating to DDI-ADRs, 3,303 were related to serious ADRs. Patients with serious DDI-ADRs had a median age of 76 years (interquartile range: 63–84); 53% were male. Of all serious DDI-ADRs, 11% were life-threatening and 8% fatal. In 36% of cases, the DDI causing the ADR involved at least three drugs. Overall, 8,424 different drugs were mentioned in the 3,303 serious DDI-ADRs considered. Altogether, drugs from the “antithrombotic agents” subgroup were incriminated in 34% of serious DDI-ADRs. Antidepressants were the second most represented therapeutic/pharmacological subgroup (5% of serious DDI-ADRs). Among the 3,843 ADR types reported in the 3,303 serious DDI-ADRs considered, the most frequently represented were hemorrhage (40% clinical hemorrhage; 6% biological hemorrhage), renal failure (8%), pharmacokinetic alteration (5%), and cardiac arrhythmias (4%). Hemorrhagic accidents are still an important part of serious ADRs resulting from DDIs reported in France. The other clinical consequences of DDIs seem less well identified by pharmacovigilance. Moreover, more than one-third of serious DDI-ADRs involved at least three drugs. Frontiers Media S.A. 2021-03-24 /pmc/articles/PMC8024557/ /pubmed/33841134 http://dx.doi.org/10.3389/fphar.2020.624562 Text en Copyright © 2021 Létinier, Ferreira, Marceron, Babin, Micallef, Miremont-Salamé and Pariente. http://creativecommons.org/licenses/by/4.0/ This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
spellingShingle Pharmacology
Létinier, Louis
Ferreira, Amandine
Marceron, Alexandre
Babin, Marina
Micallef, Joëlle
Miremont-Salamé, Ghada
Pariente, Antoine
Spontaneous Reports of Serious Adverse Drug Reactions Resulting From Drug–Drug Interactions: An Analysis From the French Pharmacovigilance Database
title Spontaneous Reports of Serious Adverse Drug Reactions Resulting From Drug–Drug Interactions: An Analysis From the French Pharmacovigilance Database
title_full Spontaneous Reports of Serious Adverse Drug Reactions Resulting From Drug–Drug Interactions: An Analysis From the French Pharmacovigilance Database
title_fullStr Spontaneous Reports of Serious Adverse Drug Reactions Resulting From Drug–Drug Interactions: An Analysis From the French Pharmacovigilance Database
title_full_unstemmed Spontaneous Reports of Serious Adverse Drug Reactions Resulting From Drug–Drug Interactions: An Analysis From the French Pharmacovigilance Database
title_short Spontaneous Reports of Serious Adverse Drug Reactions Resulting From Drug–Drug Interactions: An Analysis From the French Pharmacovigilance Database
title_sort spontaneous reports of serious adverse drug reactions resulting from drug–drug interactions: an analysis from the french pharmacovigilance database
topic Pharmacology
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8024557/
https://www.ncbi.nlm.nih.gov/pubmed/33841134
http://dx.doi.org/10.3389/fphar.2020.624562
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