"Off-label" use of hydroxychloroquine, azithromycin, lopinavir-ritonavir and chloroquine in COVID-19: A survey of cardiac adverse drug reactions by the French Network of Pharmacovigilance Centers.
Identifieur interne : 000065 ( Main/Exploration ); précédent : 000064; suivant : 000066"Off-label" use of hydroxychloroquine, azithromycin, lopinavir-ritonavir and chloroquine in COVID-19: A survey of cardiac adverse drug reactions by the French Network of Pharmacovigilance Centers.
Auteurs : Alexandre Gérard [France] ; Serena Romani [France] ; Audrey Fresse [France] ; Delphine Viard [France] ; Nadège Parassol [France] ; Aurélie Granvuillemin [France] ; Laurent Chouchana [France] ; Fanny Rocher [France] ; Milou-Daniel Drici [France]Source :
- Therapie [ 1958-5578 ]
Descripteurs français
- KwdFr :
- Adulte d'âge moyen (MeSH), Association médicamenteuse (MeSH), Azithromycine (administration et posologie), Azithromycine (effets indésirables), Cardiopathies (induit chimiquement), Cardiopathies (épidémiologie), Chloroquine (administration et posologie), Chloroquine (effets indésirables), Facteurs de risque (MeSH), Femelle (MeSH), France (épidémiologie), Humains (MeSH), Hydroxychloroquine (administration et posologie), Hydroxychloroquine (effets indésirables), Infections à coronavirus (traitement médicamenteux), Lopinavir (administration et posologie), Lopinavir (effets indésirables), Mâle (MeSH), Pandémies (MeSH), Pharmacovigilance (MeSH), Pneumopathie virale (traitement médicamenteux), Ritonavir (administration et posologie), Ritonavir (effets indésirables), Sujet âgé (MeSH), Syndrome du QT long (induit chimiquement), Syndrome du QT long (épidémiologie), Systèmes de signalement des effets indésirables des médicaments (statistiques et données numériques), Utilisation hors indication (MeSH), Électrocardiographie (MeSH).
- MESH :
- administration et posologie : Azithromycine, Chloroquine, Hydroxychloroquine, Lopinavir, Ritonavir.
- effets indésirables : Azithromycine, Chloroquine, Hydroxychloroquine, Lopinavir, Ritonavir.
- induit chimiquement : Cardiopathies, Syndrome du QT long.
- statistiques et données numériques : Systèmes de signalement des effets indésirables des médicaments.
- traitement médicamenteux : Infections à coronavirus, Pneumopathie virale.
- épidémiologie : Cardiopathies, France, Syndrome du QT long.
- Adulte d'âge moyen, Association médicamenteuse, Facteurs de risque, Femelle, Humains, Mâle, Pandémies, Pharmacovigilance, Sujet âgé, Utilisation hors indication, Électrocardiographie.
- Wicri :
- geographic : France.
English descriptors
- KwdEn :
- Adverse Drug Reaction Reporting Systems (statistics & numerical data), Aged (MeSH), Azithromycin (administration & dosage), Azithromycin (adverse effects), Chloroquine (administration & dosage), Chloroquine (adverse effects), Coronavirus Infections (drug therapy), Drug Combinations (MeSH), Electrocardiography (MeSH), Female (MeSH), France (epidemiology), Heart Diseases (chemically induced), Heart Diseases (epidemiology), Humans (MeSH), Hydroxychloroquine (administration & dosage), Hydroxychloroquine (adverse effects), Long QT Syndrome (chemically induced), Long QT Syndrome (epidemiology), Lopinavir (administration & dosage), Lopinavir (adverse effects), Male (MeSH), Middle Aged (MeSH), Off-Label Use (MeSH), Pandemics (MeSH), Pharmacovigilance (MeSH), Pneumonia, Viral (drug therapy), Risk Factors (MeSH), Ritonavir (administration & dosage), Ritonavir (adverse effects).
- MESH :
- chemical , administration & dosage : Azithromycin, Chloroquine, Hydroxychloroquine, Lopinavir, Ritonavir.
- chemical , adverse effects : Azithromycin, Chloroquine, Hydroxychloroquine, Lopinavir, Ritonavir.
- geographic , epidemiology : France.
- chemically induced : Heart Diseases, Long QT Syndrome.
- drug therapy : Coronavirus Infections, Pneumonia, Viral.
- epidemiology : Heart Diseases, Long QT Syndrome.
- statistics & numerical data : Adverse Drug Reaction Reporting Systems.
- Aged, Drug Combinations, Electrocardiography, Female, Humans, Male, Middle Aged, Off-Label Use, Pandemics, Pharmacovigilance, Risk Factors.
Abstract
INTRODUCTION
COVID-19 is an unprecedented challenge for physicians and scientists. Several publicized drugs are being used with not much evidence of their efficacy such as hydroxychloroquine, azithromycin or lopinavir-ritonavir. Yet, the cardiac safety of these drugs in COVID-19 deserves scrutiny as they are known to foster cardiac adverse ADRs, notably QTc interval prolongation on the electrocardiogram and its arrhythmogenic consequences.
METHODS
Since March 27th, 2020, the French Pharmacovigilance Network directed all cardiac adverse drug reactions associated with "off-label" use of hydroxychloroquine, azithromycin and lopinavir-ritonavir in COVID-19 to the Nice Regional Center of Pharmacovigilance. Each Regional Center of Pharmacovigilance first assessed causality of drugs. We performed a specific analysis of these cardiac adverse drug reactions amidst an array of risk factors, reassessed the electrocardiograms and estimated their incidence in coronavirus disease 2019.
RESULTS
In one month, 120 reports of cardiac adverse drug reactions have been notified, 103 of which associated with hydroxychloroquine alone (86%), or associated with azithromycin (60%). Their estimated incidence is 0.77% to 1.54% of all patients, notwithstanding strong underreporting. Lopinavir-ritonavir came third with 17 reports (14%) and chloroquine fourth with 3 reports (2.5%). There were 8 sudden, unexplained or aborted deaths (7%), 8 ventricular arrhythmias (7%), 90 reports of prolonged QTc (75%) most of them "serious" (64%), 48 of which proved ≥ 500ms, 20 reports of severe conduction disorders (17%) and 5 reports of other cardiac causes (4%). Six reports derived from automedication.
DISCUSSION AND CONCLUSION
"Off-label" use of treatments in COVID-19 increases the risk of cardiac ADRs, some of them avoidable. Even if these drugs are perceived as familiar, they are used in patients with added risk factors caused by infection. Precautions should be taken to mitigate the risk, even if they will be proven efficacious.
DOI: 10.1016/j.therap.2020.05.002
PubMed: 32418730
PubMed Central: PMC7204701
Affiliations:
- France
- Bourgogne, Bourgogne-Franche-Comté, Provence-Alpes-Côte d'Azur, Île-de-France
- Dijon, Nice, Paris
Links toward previous steps (curation, corpus...)
Le document en format XML
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type="city">Nice</settlement></placeName></affiliation></author><author><name sortKey="Romani, Serena" sort="Romani, Serena" uniqKey="Romani S" first="Serena" last="Romani">Serena Romani</name><affiliation wicri:level="3"><nlm:affiliation>Pharmacovigilance, department of pharmacology, Pasteur hospital, Bât J4, 30, avenue de la Voie-Romaine, CS51069, 06001 Nice Cedex 01, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Pharmacovigilance, department of pharmacology, Pasteur hospital, Bât J4, 30, avenue de la Voie-Romaine, CS51069, 06001 Nice Cedex 01</wicri:regionArea><placeName><region type="region" nuts="2">Provence-Alpes-Côte d'Azur</region><settlement type="city">Nice</settlement></placeName></affiliation></author><author><name sortKey="Fresse, Audrey" sort="Fresse, Audrey" uniqKey="Fresse A" first="Audrey" last="Fresse">Audrey Fresse</name><affiliation wicri:level="3"><nlm:affiliation>Pharmacovigilance, department of pharmacology, Pasteur hospital, Bât J4, 30, avenue de la Voie-Romaine, CS51069, 06001 Nice Cedex 01, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Pharmacovigilance, department of pharmacology, Pasteur hospital, Bât J4, 30, avenue de la Voie-Romaine, CS51069, 06001 Nice Cedex 01</wicri:regionArea><placeName><region type="region" nuts="2">Provence-Alpes-Côte d'Azur</region><settlement type="city">Nice</settlement></placeName></affiliation></author><author><name sortKey="Viard, Delphine" sort="Viard, Delphine" uniqKey="Viard D" first="Delphine" last="Viard">Delphine Viard</name><affiliation wicri:level="3"><nlm:affiliation>Pharmacovigilance, department of pharmacology, Pasteur hospital, Bât J4, 30, avenue de la Voie-Romaine, CS51069, 06001 Nice Cedex 01, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Pharmacovigilance, department of pharmacology, Pasteur hospital, Bât J4, 30, avenue de la Voie-Romaine, CS51069, 06001 Nice Cedex 01</wicri:regionArea><placeName><region type="region" nuts="2">Provence-Alpes-Côte d'Azur</region><settlement type="city">Nice</settlement></placeName></affiliation></author><author><name sortKey="Parassol, Nadege" sort="Parassol, Nadege" uniqKey="Parassol N" first="Nadège" last="Parassol">Nadège Parassol</name><affiliation wicri:level="3"><nlm:affiliation>Pharmacovigilance, department of pharmacology, Pasteur hospital, Bât J4, 30, avenue de la Voie-Romaine, CS51069, 06001 Nice Cedex 01, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Pharmacovigilance, department of pharmacology, Pasteur hospital, Bât J4, 30, avenue de la Voie-Romaine, CS51069, 06001 Nice Cedex 01</wicri:regionArea><placeName><region type="region" nuts="2">Provence-Alpes-Côte d'Azur</region><settlement type="city">Nice</settlement></placeName></affiliation></author><author><name sortKey="Granvuillemin, Aurelie" sort="Granvuillemin, Aurelie" uniqKey="Granvuillemin A" first="Aurélie" last="Granvuillemin">Aurélie Granvuillemin</name><affiliation wicri:level="3"><nlm:affiliation>Centre régional de pharmacovigilance, 21079 Dijon, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Centre régional de pharmacovigilance, 21079 Dijon</wicri:regionArea><placeName><region type="region" nuts="2">Bourgogne-Franche-Comté</region><region type="old region" nuts="2">Bourgogne</region><settlement type="city">Dijon</settlement></placeName></affiliation></author><author><name sortKey="Chouchana, Laurent" sort="Chouchana, Laurent" uniqKey="Chouchana L" first="Laurent" last="Chouchana">Laurent Chouchana</name><affiliation wicri:level="3"><nlm:affiliation>Centre régional de pharmacovigilance Paris-Cochin, 75014 Paris, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Centre régional de pharmacovigilance Paris-Cochin, 75014 Paris</wicri:regionArea><placeName><region type="region" nuts="2">Île-de-France</region><settlement type="city">Paris</settlement></placeName></affiliation></author><author><name sortKey="Rocher, Fanny" sort="Rocher, Fanny" uniqKey="Rocher F" first="Fanny" last="Rocher">Fanny Rocher</name><affiliation wicri:level="3"><nlm:affiliation>Pharmacovigilance, department of pharmacology, Pasteur hospital, Bât J4, 30, avenue de la Voie-Romaine, CS51069, 06001 Nice Cedex 01, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Pharmacovigilance, department of pharmacology, Pasteur hospital, Bât J4, 30, avenue de la Voie-Romaine, CS51069, 06001 Nice Cedex 01</wicri:regionArea><placeName><region type="region" nuts="2">Provence-Alpes-Côte d'Azur</region><settlement type="city">Nice</settlement></placeName></affiliation></author><author><name sortKey="Drici, Milou Daniel" sort="Drici, Milou Daniel" uniqKey="Drici M" first="Milou-Daniel" last="Drici">Milou-Daniel Drici</name><affiliation wicri:level="3"><nlm:affiliation>Pharmacovigilance, department of pharmacology, Pasteur hospital, Bât J4, 30, avenue de la Voie-Romaine, CS51069, 06001 Nice Cedex 01, France. Electronic address: pharmacovigilance@chu-nice.fr.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Pharmacovigilance, department of pharmacology, Pasteur hospital, Bât J4, 30, avenue de la Voie-Romaine, CS51069, 06001 Nice Cedex 01</wicri:regionArea><placeName><region type="region" nuts="2">Provence-Alpes-Côte d'Azur</region><settlement type="city">Nice</settlement></placeName></affiliation></author></analytic><series><title level="j">Therapie</title><idno type="eISSN">1958-5578</idno></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adverse Drug Reaction Reporting Systems (statistics & numerical data)</term><term>Aged (MeSH)</term><term>Azithromycin (administration & dosage)</term><term>Azithromycin (adverse effects)</term><term>Chloroquine (administration & dosage)</term><term>Chloroquine (adverse effects)</term><term>Coronavirus Infections (drug therapy)</term><term>Drug Combinations (MeSH)</term><term>Electrocardiography (MeSH)</term><term>Female (MeSH)</term><term>France (epidemiology)</term><term>Heart Diseases (chemically induced)</term><term>Heart Diseases (epidemiology)</term><term>Humans (MeSH)</term><term>Hydroxychloroquine (administration & dosage)</term><term>Hydroxychloroquine (adverse effects)</term><term>Long QT Syndrome (chemically induced)</term><term>Long QT Syndrome (epidemiology)</term><term>Lopinavir (administration & dosage)</term><term>Lopinavir (adverse effects)</term><term>Male (MeSH)</term><term>Middle Aged (MeSH)</term><term>Off-Label Use (MeSH)</term><term>Pandemics (MeSH)</term><term>Pharmacovigilance (MeSH)</term><term>Pneumonia, Viral (drug therapy)</term><term>Risk Factors (MeSH)</term><term>Ritonavir (administration & dosage)</term><term>Ritonavir (adverse effects)</term></keywords><keywords scheme="KwdFr" xml:lang="fr"><term>Adulte d'âge moyen (MeSH)</term><term>Association médicamenteuse (MeSH)</term><term>Azithromycine (administration et posologie)</term><term>Azithromycine (effets indésirables)</term><term>Cardiopathies (induit chimiquement)</term><term>Cardiopathies (épidémiologie)</term><term>Chloroquine (administration et posologie)</term><term>Chloroquine (effets indésirables)</term><term>Facteurs de risque (MeSH)</term><term>Femelle (MeSH)</term><term>France (épidémiologie)</term><term>Humains (MeSH)</term><term>Hydroxychloroquine (administration et posologie)</term><term>Hydroxychloroquine (effets indésirables)</term><term>Infections à coronavirus (traitement médicamenteux)</term><term>Lopinavir (administration et posologie)</term><term>Lopinavir (effets indésirables)</term><term>Mâle (MeSH)</term><term>Pandémies (MeSH)</term><term>Pharmacovigilance (MeSH)</term><term>Pneumopathie virale (traitement médicamenteux)</term><term>Ritonavir (administration et posologie)</term><term>Ritonavir (effets indésirables)</term><term>Sujet âgé (MeSH)</term><term>Syndrome du QT long (induit chimiquement)</term><term>Syndrome du QT long (épidémiologie)</term><term>Systèmes de signalement des effets indésirables des médicaments (statistiques et données numériques)</term><term>Utilisation hors indication (MeSH)</term><term>Électrocardiographie (MeSH)</term></keywords><keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en"><term>Azithromycin</term><term>Chloroquine</term><term>Hydroxychloroquine</term><term>Lopinavir</term><term>Ritonavir</term></keywords><keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en"><term>Azithromycin</term><term>Chloroquine</term><term>Hydroxychloroquine</term><term>Lopinavir</term><term>Ritonavir</term></keywords><keywords scheme="MESH" type="geographic" qualifier="epidemiology" xml:lang="en"><term>France</term></keywords><keywords scheme="MESH" qualifier="administration et posologie" xml:lang="fr"><term>Azithromycine</term><term>Chloroquine</term><term>Hydroxychloroquine</term><term>Lopinavir</term><term>Ritonavir</term></keywords><keywords scheme="MESH" qualifier="chemically induced" xml:lang="en"><term>Heart Diseases</term><term>Long QT Syndrome</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Coronavirus Infections</term><term>Pneumonia, Viral</term></keywords><keywords scheme="MESH" qualifier="effets indésirables" xml:lang="fr"><term>Azithromycine</term><term>Chloroquine</term><term>Hydroxychloroquine</term><term>Lopinavir</term><term>Ritonavir</term></keywords><keywords scheme="MESH" qualifier="epidemiology" xml:lang="en"><term>Heart Diseases</term><term>Long QT Syndrome</term></keywords><keywords scheme="MESH" qualifier="induit chimiquement" xml:lang="fr"><term>Cardiopathies</term><term>Syndrome du QT long</term></keywords><keywords scheme="MESH" qualifier="statistics & numerical data" xml:lang="en"><term>Adverse Drug Reaction Reporting Systems</term></keywords><keywords scheme="MESH" qualifier="statistiques et données numériques" xml:lang="fr"><term>Systèmes de signalement des effets indésirables des médicaments</term></keywords><keywords scheme="MESH" qualifier="traitement médicamenteux" xml:lang="fr"><term>Infections à coronavirus</term><term>Pneumopathie virale</term></keywords><keywords scheme="MESH" qualifier="épidémiologie" xml:lang="fr"><term>Cardiopathies</term><term>France</term><term>Syndrome du QT long</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Aged</term><term>Drug Combinations</term><term>Electrocardiography</term><term>Female</term><term>Humans</term><term>Male</term><term>Middle Aged</term><term>Off-Label Use</term><term>Pandemics</term><term>Pharmacovigilance</term><term>Risk Factors</term></keywords><keywords scheme="MESH" xml:lang="fr"><term>Adulte d'âge moyen</term><term>Association médicamenteuse</term><term>Facteurs de risque</term><term>Femelle</term><term>Humains</term><term>Mâle</term><term>Pandémies</term><term>Pharmacovigilance</term><term>Sujet âgé</term><term>Utilisation hors indication</term><term>Électrocardiographie</term></keywords><keywords scheme="Wicri" type="geographic" xml:lang="fr"><term>France</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><p><b>INTRODUCTION</b></p><p>COVID-19 is an unprecedented challenge for physicians and scientists. Several publicized drugs are being used with not much evidence of their efficacy such as hydroxychloroquine, azithromycin or lopinavir-ritonavir. Yet, the cardiac safety of these drugs in COVID-19 deserves scrutiny as they are known to foster cardiac adverse ADRs, notably QTc interval prolongation on the electrocardiogram and its arrhythmogenic consequences.</p></div><div type="abstract" xml:lang="en"><p><b>METHODS</b></p><p>Since March 27th, 2020, the French Pharmacovigilance Network directed all cardiac adverse drug reactions associated with "off-label" use of hydroxychloroquine, azithromycin and lopinavir-ritonavir in COVID-19 to the Nice Regional Center of Pharmacovigilance. Each Regional Center of Pharmacovigilance first assessed causality of drugs. We performed a specific analysis of these cardiac adverse drug reactions amidst an array of risk factors, reassessed the electrocardiograms and estimated their incidence in coronavirus disease 2019.</p></div><div type="abstract" xml:lang="en"><p><b>RESULTS</b></p><p>In one month, 120 reports of cardiac adverse drug reactions have been notified, 103 of which associated with hydroxychloroquine alone (86%), or associated with azithromycin (60%). Their estimated incidence is 0.77% to 1.54% of all patients, notwithstanding strong underreporting. Lopinavir-ritonavir came third with 17 reports (14%) and chloroquine fourth with 3 reports (2.5%). There were 8 sudden, unexplained or aborted deaths (7%), 8 ventricular arrhythmias (7%), 90 reports of prolonged QTc (75%) most of them "serious" (64%), 48 of which proved ≥ 500ms, 20 reports of severe conduction disorders (17%) and 5 reports of other cardiac causes (4%). Six reports derived from automedication.</p></div><div type="abstract" xml:lang="en"><p><b>DISCUSSION AND CONCLUSION</b></p><p>"Off-label" use of treatments in COVID-19 increases the risk of cardiac ADRs, some of them avoidable. Even if these drugs are perceived as familiar, they are used in patients with added risk factors caused by infection. Precautions should be taken to mitigate the risk, even if they will be proven efficacious.</p></div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">32418730</PMID><DateCompleted><Year>2020</Year><Month>09</Month><Day>01</Day></DateCompleted><DateRevised><Year>2020</Year><Month>09</Month><Day>01</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1958-5578</ISSN><JournalIssue CitedMedium="Internet"><Volume>75</Volume><Issue>4</Issue><PubDate><MedlineDate>2020 Jul - Aug</MedlineDate></PubDate></JournalIssue><Title>Therapie</Title><ISOAbbreviation>Therapie</ISOAbbreviation></Journal><ArticleTitle>"Off-label" use of hydroxychloroquine, azithromycin, lopinavir-ritonavir and chloroquine in COVID-19: A survey of cardiac adverse drug reactions by the French Network of Pharmacovigilance Centers.</ArticleTitle><Pagination><MedlinePgn>371-379</MedlinePgn></Pagination><ELocationID EIdType="pii" ValidYN="Y">S0040-5957(20)30091-3</ELocationID><ELocationID EIdType="doi" ValidYN="Y">10.1016/j.therap.2020.05.002</ELocationID><Abstract><AbstractText Label="INTRODUCTION" NlmCategory="BACKGROUND">COVID-19 is an unprecedented challenge for physicians and scientists. Several publicized drugs are being used with not much evidence of their efficacy such as hydroxychloroquine, azithromycin or lopinavir-ritonavir. Yet, the cardiac safety of these drugs in COVID-19 deserves scrutiny as they are known to foster cardiac adverse ADRs, notably QTc interval prolongation on the electrocardiogram and its arrhythmogenic consequences.</AbstractText><AbstractText Label="METHODS" NlmCategory="METHODS">Since March 27th, 2020, the French Pharmacovigilance Network directed all cardiac adverse drug reactions associated with "off-label" use of hydroxychloroquine, azithromycin and lopinavir-ritonavir in COVID-19 to the Nice Regional Center of Pharmacovigilance. Each Regional Center of Pharmacovigilance first assessed causality of drugs. We performed a specific analysis of these cardiac adverse drug reactions amidst an array of risk factors, reassessed the electrocardiograms and estimated their incidence in coronavirus disease 2019.</AbstractText><AbstractText Label="RESULTS" NlmCategory="RESULTS">In one month, 120 reports of cardiac adverse drug reactions have been notified, 103 of which associated with hydroxychloroquine alone (86%), or associated with azithromycin (60%). Their estimated incidence is 0.77% to 1.54% of all patients, notwithstanding strong underreporting. Lopinavir-ritonavir came third with 17 reports (14%) and chloroquine fourth with 3 reports (2.5%). There were 8 sudden, unexplained or aborted deaths (7%), 8 ventricular arrhythmias (7%), 90 reports of prolonged QTc (75%) most of them "serious" (64%), 48 of which proved ≥ 500ms, 20 reports of severe conduction disorders (17%) and 5 reports of other cardiac causes (4%). Six reports derived from automedication.</AbstractText><AbstractText Label="DISCUSSION AND CONCLUSION" NlmCategory="CONCLUSIONS">"Off-label" use of treatments in COVID-19 increases the risk of cardiac ADRs, some of them avoidable. Even if these drugs are perceived as familiar, they are used in patients with added risk factors caused by infection. Precautions should be taken to mitigate the risk, even if they will be proven efficacious.</AbstractText><CopyrightInformation>Copyright © 2020 Société française de pharmacologie et de thérapeutique. Published by Elsevier Masson SAS. All rights reserved.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Gérard</LastName><ForeName>Alexandre</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>Pharmacovigilance, department of pharmacology, Pasteur hospital, Bât J4, 30, avenue de la Voie-Romaine, CS51069, 06001 Nice Cedex 01, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Romani</LastName><ForeName>Serena</ForeName><Initials>S</Initials><AffiliationInfo><Affiliation>Pharmacovigilance, department of pharmacology, Pasteur hospital, Bât J4, 30, avenue de la Voie-Romaine, CS51069, 06001 Nice Cedex 01, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Fresse</LastName><ForeName>Audrey</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>Pharmacovigilance, department of pharmacology, Pasteur hospital, Bât J4, 30, avenue de la Voie-Romaine, CS51069, 06001 Nice Cedex 01, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Viard</LastName><ForeName>Delphine</ForeName><Initials>D</Initials><AffiliationInfo><Affiliation>Pharmacovigilance, department of pharmacology, Pasteur hospital, Bât J4, 30, avenue de la Voie-Romaine, CS51069, 06001 Nice Cedex 01, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Parassol</LastName><ForeName>Nadège</ForeName><Initials>N</Initials><AffiliationInfo><Affiliation>Pharmacovigilance, department of pharmacology, Pasteur hospital, Bât J4, 30, avenue de la Voie-Romaine, CS51069, 06001 Nice Cedex 01, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Granvuillemin</LastName><ForeName>Aurélie</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>Centre régional de pharmacovigilance, 21079 Dijon, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Chouchana</LastName><ForeName>Laurent</ForeName><Initials>L</Initials><AffiliationInfo><Affiliation>Centre régional de pharmacovigilance Paris-Cochin, 75014 Paris, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Rocher</LastName><ForeName>Fanny</ForeName><Initials>F</Initials><AffiliationInfo><Affiliation>Pharmacovigilance, department of pharmacology, Pasteur hospital, Bât J4, 30, avenue de la Voie-Romaine, CS51069, 06001 Nice Cedex 01, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Drici</LastName><ForeName>Milou-Daniel</ForeName><Initials>MD</Initials><AffiliationInfo><Affiliation>Pharmacovigilance, department of pharmacology, Pasteur hospital, Bât J4, 30, avenue de la Voie-Romaine, CS51069, 06001 Nice Cedex 01, France. Electronic address: pharmacovigilance@chu-nice.fr.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><CollectiveName>French Network of Pharmacovigilance Centers</CollectiveName></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2020</Year><Month>05</Month><Day>07</Day></ArticleDate></Article><MedlineJournalInfo><Country>France</Country><MedlineTA>Therapie</MedlineTA><NlmUniqueID>0420544</NlmUniqueID><ISSNLinking>0040-5957</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D004338">Drug Combinations</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="C558899">lopinavir-ritonavir drug combination</NameOfSubstance></Chemical><Chemical><RegistryNumber>2494G1JF75</RegistryNumber><NameOfSubstance UI="D061466">Lopinavir</NameOfSubstance></Chemical><Chemical><RegistryNumber>4QWG6N8QKH</RegistryNumber><NameOfSubstance UI="D006886">Hydroxychloroquine</NameOfSubstance></Chemical><Chemical><RegistryNumber>83905-01-5</RegistryNumber><NameOfSubstance UI="D017963">Azithromycin</NameOfSubstance></Chemical><Chemical><RegistryNumber>886U3H6UFF</RegistryNumber><NameOfSubstance UI="D002738">Chloroquine</NameOfSubstance></Chemical><Chemical><RegistryNumber>O3J8G9O825</RegistryNumber><NameOfSubstance UI="D019438">Ritonavir</NameOfSubstance></Chemical></ChemicalList><SupplMeshList><SupplMeshName Type="Disease" UI="C000657245">COVID-19</SupplMeshName><SupplMeshName Type="Protocol" UI="C000705127">COVID-19 drug treatment</SupplMeshName></SupplMeshList><CitationSubset>IM</CitationSubset><MeshHeadingList><MeshHeading><DescriptorName UI="D016907" MajorTopicYN="N">Adverse Drug Reaction Reporting Systems</DescriptorName><QualifierName UI="Q000706" MajorTopicYN="N">statistics & numerical data</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D000368" MajorTopicYN="N">Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D017963" MajorTopicYN="N">Azithromycin</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="N">administration & dosage</QualifierName><QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D002738" MajorTopicYN="N">Chloroquine</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="N">administration & dosage</QualifierName><QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D018352" MajorTopicYN="N">Coronavirus Infections</DescriptorName><QualifierName UI="Q000188" MajorTopicYN="Y">drug therapy</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D004338" MajorTopicYN="N">Drug Combinations</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D004562" MajorTopicYN="N">Electrocardiography</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D005260" MajorTopicYN="N">Female</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D005602" MajorTopicYN="N" Type="Geographic">France</DescriptorName><QualifierName UI="Q000453" MajorTopicYN="N">epidemiology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D006331" MajorTopicYN="N">Heart Diseases</DescriptorName><QualifierName UI="Q000139" MajorTopicYN="Y">chemically induced</QualifierName><QualifierName UI="Q000453" MajorTopicYN="N">epidemiology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D006886" MajorTopicYN="N">Hydroxychloroquine</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="N">administration & dosage</QualifierName><QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D008133" MajorTopicYN="N">Long QT Syndrome</DescriptorName><QualifierName UI="Q000139" MajorTopicYN="N">chemically induced</QualifierName><QualifierName UI="Q000453" MajorTopicYN="N">epidemiology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D061466" MajorTopicYN="N">Lopinavir</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="N">administration & dosage</QualifierName><QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D008297" MajorTopicYN="N">Male</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D008875" MajorTopicYN="N">Middle Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D056687" MajorTopicYN="Y">Off-Label Use</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D058873" MajorTopicYN="N">Pandemics</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D060735" MajorTopicYN="Y">Pharmacovigilance</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D011024" MajorTopicYN="N">Pneumonia, Viral</DescriptorName><QualifierName UI="Q000188" MajorTopicYN="Y">drug therapy</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D012307" MajorTopicYN="N">Risk Factors</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D019438" MajorTopicYN="N">Ritonavir</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="N">administration & dosage</QualifierName><QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName></MeshHeading></MeshHeadingList><KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="N">Arrhythmia</Keyword><Keyword MajorTopicYN="N">Azithromycin</Keyword><Keyword MajorTopicYN="N">COVID-19</Keyword><Keyword MajorTopicYN="N">Cardiac adverse effects</Keyword><Keyword MajorTopicYN="N">Hydroxychloroquine</Keyword><Keyword MajorTopicYN="N">Lopinavir</Keyword><Keyword MajorTopicYN="N">QTc prolongation</Keyword></KeywordList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="received"><Year>2020</Year><Month>04</Month><Day>30</Day></PubMedPubDate><PubMedPubDate PubStatus="accepted"><Year>2020</Year><Month>05</Month><Day>05</Day></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2020</Year><Month>5</Month><Day>19</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2020</Year><Month>9</Month><Day>2</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2020</Year><Month>5</Month><Day>19</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">32418730</ArticleId><ArticleId IdType="pii">S0040-5957(20)30091-3</ArticleId><ArticleId IdType="doi">10.1016/j.therap.2020.05.002</ArticleId><ArticleId IdType="pmc">PMC7204701</ArticleId></ArticleIdList></PubmedData></pubmed><affiliations><list><country><li>France</li></country><region><li>Bourgogne</li><li>Bourgogne-Franche-Comté</li><li>Provence-Alpes-Côte d'Azur</li><li>Île-de-France</li></region><settlement><li>Dijon</li><li>Nice</li><li>Paris</li></settlement></list><tree><country name="France"><region name="Provence-Alpes-Côte d'Azur"><name sortKey="Gerard, Alexandre" sort="Gerard, Alexandre" uniqKey="Gerard A" first="Alexandre" last="Gérard">Alexandre Gérard</name></region><name sortKey="Chouchana, Laurent" sort="Chouchana, Laurent" uniqKey="Chouchana L" first="Laurent" last="Chouchana">Laurent Chouchana</name><name sortKey="Drici, Milou Daniel" sort="Drici, Milou Daniel" uniqKey="Drici M" first="Milou-Daniel" last="Drici">Milou-Daniel Drici</name><name sortKey="Fresse, Audrey" sort="Fresse, Audrey" uniqKey="Fresse A" first="Audrey" last="Fresse">Audrey Fresse</name><name sortKey="Granvuillemin, Aurelie" sort="Granvuillemin, Aurelie" uniqKey="Granvuillemin A" first="Aurélie" last="Granvuillemin">Aurélie Granvuillemin</name><name sortKey="Parassol, Nadege" sort="Parassol, Nadege" uniqKey="Parassol N" first="Nadège" last="Parassol">Nadège Parassol</name><name sortKey="Rocher, Fanny" sort="Rocher, Fanny" uniqKey="Rocher F" first="Fanny" last="Rocher">Fanny Rocher</name><name sortKey="Romani, Serena" sort="Romani, Serena" uniqKey="Romani S" first="Serena" last="Romani">Serena Romani</name><name sortKey="Viard, Delphine" sort="Viard, Delphine" uniqKey="Viard D" first="Delphine" last="Viard">Delphine Viard</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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