Safety signals for QT prolongation or Torsades de Pointes associated with azithromycin with or without chloroquine or hydroxychloroquine.
Identifieur interne : 001902 ( Main/Corpus ); précédent : 001901; suivant : 001903Safety signals for QT prolongation or Torsades de Pointes associated with azithromycin with or without chloroquine or hydroxychloroquine.
Auteurs : Amir Sarayani ; Brian Cicali ; Carl H. Henriksen ; Joshua D. BrownSource :
- Research in social & administrative pharmacy : RSAP [ 1934-8150 ] ; 2021.
English descriptors
- KwdEn :
- Antiviral Agents (adverse effects), Antiviral Agents (therapeutic use), Azithromycin (adverse effects), Azithromycin (therapeutic use), COVID-19 (complications), COVID-19 (drug therapy), Chloroquine (adverse effects), Chloroquine (therapeutic use), Drug Interactions (MeSH), Drug Therapy, Combination (MeSH), Humans (MeSH), Hydroxychloroquine (adverse effects), Hydroxychloroquine (therapeutic use), Long QT Syndrome (chemically induced), Long QT Syndrome (mortality), Pharmacovigilance (MeSH), Torsades de Pointes (chemically induced), Torsades de Pointes (mortality), United States (epidemiology).
- MESH :
- chemical , adverse effects : Antiviral Agents, Azithromycin, Chloroquine, Hydroxychloroquine.
- chemical , therapeutic use : Antiviral Agents, Azithromycin, Chloroquine, Hydroxychloroquine.
- geographic , epidemiology : United States.
- chemically induced : Long QT Syndrome, Torsades de Pointes.
- complications : COVID-19.
- drug therapy : COVID-19.
- mortality : Long QT Syndrome, Torsades de Pointes.
- Drug Interactions, Drug Therapy, Combination, Humans, Pharmacovigilance.
Abstract
Background
Combinations of hydroxychloroquine (HCQ) and azithromycin have been promoted as treatments for COVID-19 based on small, uncontrolled clinical trials that have not assessed potential risks. Risks of treatment include QT segment prolongation, Torsades de Pointes (TdP), and death. This comparative pharmacovigilance analysis evaluated the risk of these events.
Methods
Data from the U.S. Food and Drug Administration's Adverse Event Reporting System (FAERS) (>13 million total reports) were used. Queries extracted reports based on exposures of HCQ/chloroquine (CQ) alone, azithromycin alone, HCQ/CQ + azithromycin, amoxicillin alone, HCQ/CQ + amoxicillin alone. Amoxicillin served as a control. Events of interest included death and TdP/QT prolongation as well as accidents/injuries and depression as control events. Proportional Reporting Ratios (PRR) and 95% confidence intervals (CI) were calculated where a lower limit of the of 95% CI (Lower95CI) value of ≥2.0 is interpreted as a potential safety signal.
Results
Lower95CIs for HCQ/CQ alone showed no potential safety signals for TdP/QT prolongation, death, or any of the control events included. The PRRs and 95% CIs for TdP/QT prolongation was 1.43 (1.29-2.59) with HCQ/CQ use alone and 4.10 (3.80-4.42) for azithromycin alone. For the combined HCQ/CQ + azithromycin group, the PRR and 95% CI was 3.77 (1.80-7.87). For the control of amoxicillin, there were no safety signals when used alone or in combination with HCQ/CQ.
Conclusions
HCQ/CQ use was not associated with a safety signal in this analysis of FAERS data. However, azithromycin used alone was associated with TdP/QT prolongation events and should be used with caution.
DOI: 10.1016/j.sapharm.2020.04.016
PubMed: 32327397
PubMed Central: PMC7166303
Links to Exploration step
pubmed:32327397Le document en format XML
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Henriksen</name><affiliation><nlm:affiliation>Center for Drug Evaluation and Safety, Department of Pharmaceutical Outcomes & Policy, University of Florida College of Pharmacy, Gainesville, FL, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Brown, Joshua D" sort="Brown, Joshua D" uniqKey="Brown J" first="Joshua D" last="Brown">Joshua D. Brown</name><affiliation><nlm:affiliation>Center for Drug Evaluation and Safety, Department of Pharmaceutical Outcomes & Policy, University of Florida College of Pharmacy, Gainesville, FL, USA. Electronic address: joshua.brown@ufl.edu.</nlm:affiliation></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2021">2021</date><idno type="RBID">pubmed:32327397</idno><idno type="pmid">32327397</idno><idno type="doi">10.1016/j.sapharm.2020.04.016</idno><idno type="pmc">PMC7166303</idno><idno type="wicri:Area/Main/Corpus">001902</idno><idno type="wicri:explorRef" wicri:stream="Main" wicri:step="Corpus" wicri:corpus="PubMed">001902</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Safety signals for QT prolongation or Torsades de Pointes associated with azithromycin with or without chloroquine or hydroxychloroquine.</title><author><name sortKey="Sarayani, Amir" sort="Sarayani, Amir" uniqKey="Sarayani A" first="Amir" last="Sarayani">Amir Sarayani</name><affiliation><nlm:affiliation>Center for Drug Evaluation and Safety, Department of Pharmaceutical Outcomes & Policy, University of Florida College of Pharmacy, Gainesville, FL, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Cicali, Brian" sort="Cicali, Brian" uniqKey="Cicali B" first="Brian" last="Cicali">Brian Cicali</name><affiliation><nlm:affiliation>Center for Systems Pharmacology and Pharmacometrics, Department of Pharmaceutics, University of Florida College of Pharmacy, Orlando, FL, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Henriksen, Carl H" sort="Henriksen, Carl H" uniqKey="Henriksen C" first="Carl H" last="Henriksen">Carl H. Henriksen</name><affiliation><nlm:affiliation>Center for Drug Evaluation and Safety, Department of Pharmaceutical Outcomes & Policy, University of Florida College of Pharmacy, Gainesville, FL, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Brown, Joshua D" sort="Brown, Joshua D" uniqKey="Brown J" first="Joshua D" last="Brown">Joshua D. Brown</name><affiliation><nlm:affiliation>Center for Drug Evaluation and Safety, Department of Pharmaceutical Outcomes & Policy, University of Florida College of Pharmacy, Gainesville, FL, USA. Electronic address: joshua.brown@ufl.edu.</nlm:affiliation></affiliation></author></analytic><series><title level="j">Research in social & administrative pharmacy : RSAP</title><idno type="eISSN">1934-8150</idno><imprint><date when="2021" type="published">2021</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Antiviral Agents (adverse effects)</term><term>Antiviral Agents (therapeutic use)</term><term>Azithromycin (adverse effects)</term><term>Azithromycin (therapeutic use)</term><term>COVID-19 (complications)</term><term>COVID-19 (drug therapy)</term><term>Chloroquine (adverse effects)</term><term>Chloroquine (therapeutic use)</term><term>Drug Interactions (MeSH)</term><term>Drug Therapy, Combination (MeSH)</term><term>Humans (MeSH)</term><term>Hydroxychloroquine (adverse effects)</term><term>Hydroxychloroquine (therapeutic use)</term><term>Long QT Syndrome (chemically induced)</term><term>Long QT Syndrome (mortality)</term><term>Pharmacovigilance (MeSH)</term><term>Torsades de Pointes (chemically induced)</term><term>Torsades de Pointes (mortality)</term><term>United States (epidemiology)</term></keywords><keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en"><term>Antiviral Agents</term><term>Azithromycin</term><term>Chloroquine</term><term>Hydroxychloroquine</term></keywords><keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Antiviral Agents</term><term>Azithromycin</term><term>Chloroquine</term><term>Hydroxychloroquine</term></keywords><keywords scheme="MESH" type="geographic" qualifier="epidemiology" xml:lang="en"><term>United States</term></keywords><keywords scheme="MESH" qualifier="chemically induced" xml:lang="en"><term>Long QT Syndrome</term><term>Torsades de Pointes</term></keywords><keywords scheme="MESH" qualifier="complications" xml:lang="en"><term>COVID-19</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>COVID-19</term></keywords><keywords scheme="MESH" qualifier="mortality" xml:lang="en"><term>Long QT Syndrome</term><term>Torsades de Pointes</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Drug Interactions</term><term>Drug Therapy, Combination</term><term>Humans</term><term>Pharmacovigilance</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><p><b>Background</b></p><p>Combinations of hydroxychloroquine (HCQ) and azithromycin have been promoted as treatments for COVID-19 based on small, uncontrolled clinical trials that have not assessed potential risks. Risks of treatment include QT segment prolongation, Torsades de Pointes (TdP), and death. This comparative pharmacovigilance analysis evaluated the risk of these events.</p></div><div type="abstract" xml:lang="en"><p><b>Methods</b></p><p>Data from the U.S. Food and Drug Administration's Adverse Event Reporting System (FAERS) (>13 million total reports) were used. Queries extracted reports based on exposures of HCQ/chloroquine (CQ) alone, azithromycin alone, HCQ/CQ + azithromycin, amoxicillin alone, HCQ/CQ + amoxicillin alone. Amoxicillin served as a control. Events of interest included death and TdP/QT prolongation as well as accidents/injuries and depression as control events. Proportional Reporting Ratios (PRR) and 95% confidence intervals (CI) were calculated where a lower limit of the of 95% CI (Lower95CI) value of ≥2.0 is interpreted as a potential safety signal.</p></div><div type="abstract" xml:lang="en"><p><b>Results</b></p><p>Lower95CIs for HCQ/CQ alone showed no potential safety signals for TdP/QT prolongation, death, or any of the control events included. The PRRs and 95% CIs for TdP/QT prolongation was 1.43 (1.29-2.59) with HCQ/CQ use alone and 4.10 (3.80-4.42) for azithromycin alone. For the combined HCQ/CQ + azithromycin group, the PRR and 95% CI was 3.77 (1.80-7.87). For the control of amoxicillin, there were no safety signals when used alone or in combination with HCQ/CQ.</p></div><div type="abstract" xml:lang="en"><p><b>Conclusions</b></p><p>HCQ/CQ use was not associated with a safety signal in this analysis of FAERS data. However, azithromycin used alone was associated with TdP/QT prolongation events and should be used with caution.</p></div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">32327397</PMID><DateCompleted><Year>2021</Year><Month>01</Month><Day>07</Day></DateCompleted><DateRevised><Year>2021</Year><Month>01</Month><Day>29</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1934-8150</ISSN><JournalIssue CitedMedium="Internet"><Volume>17</Volume><Issue>2</Issue><PubDate><Year>2021</Year><Month>02</Month></PubDate></JournalIssue><Title>Research in social & administrative pharmacy : RSAP</Title><ISOAbbreviation>Res Social Adm Pharm</ISOAbbreviation></Journal><ArticleTitle>Safety signals for QT prolongation or Torsades de Pointes associated with azithromycin with or without chloroquine or hydroxychloroquine.</ArticleTitle><Pagination><MedlinePgn>483-486</MedlinePgn></Pagination><ELocationID EIdType="pii" ValidYN="Y">S1551-7411(20)30391-0</ELocationID><ELocationID EIdType="doi" ValidYN="Y">10.1016/j.sapharm.2020.04.016</ELocationID><Abstract><AbstractText Label="Background">Combinations of hydroxychloroquine (HCQ) and azithromycin have been promoted as treatments for COVID-19 based on small, uncontrolled clinical trials that have not assessed potential risks. Risks of treatment include QT segment prolongation, Torsades de Pointes (TdP), and death. This comparative pharmacovigilance analysis evaluated the risk of these events.</AbstractText><AbstractText Label="Methods">Data from the U.S. Food and Drug Administration's Adverse Event Reporting System (FAERS) (>13 million total reports) were used. Queries extracted reports based on exposures of HCQ/chloroquine (CQ) alone, azithromycin alone, HCQ/CQ + azithromycin, amoxicillin alone, HCQ/CQ + amoxicillin alone. Amoxicillin served as a control. Events of interest included death and TdP/QT prolongation as well as accidents/injuries and depression as control events. Proportional Reporting Ratios (PRR) and 95% confidence intervals (CI) were calculated where a lower limit of the of 95% CI (Lower95CI) value of ≥2.0 is interpreted as a potential safety signal.</AbstractText><AbstractText Label="Results">Lower95CIs for HCQ/CQ alone showed no potential safety signals for TdP/QT prolongation, death, or any of the control events included. The PRRs and 95% CIs for TdP/QT prolongation was 1.43 (1.29-2.59) with HCQ/CQ use alone and 4.10 (3.80-4.42) for azithromycin alone. For the combined HCQ/CQ + azithromycin group, the PRR and 95% CI was 3.77 (1.80-7.87). For the control of amoxicillin, there were no safety signals when used alone or in combination with HCQ/CQ.</AbstractText><AbstractText Label="Conclusions">HCQ/CQ use was not associated with a safety signal in this analysis of FAERS data. However, azithromycin used alone was associated with TdP/QT prolongation events and should be used with caution.</AbstractText><CopyrightInformation>© 2020 Elsevier Inc. All rights reserved.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Sarayani</LastName><ForeName>Amir</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>Center for Drug Evaluation and Safety, Department of Pharmaceutical Outcomes & Policy, University of Florida College of Pharmacy, Gainesville, FL, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Cicali</LastName><ForeName>Brian</ForeName><Initials>B</Initials><AffiliationInfo><Affiliation>Center for Systems Pharmacology and Pharmacometrics, Department of Pharmaceutics, University of Florida College of Pharmacy, Orlando, FL, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Henriksen</LastName><ForeName>Carl H</ForeName><Initials>CH</Initials><AffiliationInfo><Affiliation>Center for Drug Evaluation and Safety, Department of Pharmaceutical Outcomes & Policy, University of Florida College of Pharmacy, Gainesville, FL, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Brown</LastName><ForeName>Joshua D</ForeName><Initials>JD</Initials><AffiliationInfo><Affiliation>Center for Drug Evaluation and Safety, Department of Pharmaceutical Outcomes & Policy, University of Florida College of Pharmacy, Gainesville, FL, USA. Electronic address: joshua.brown@ufl.edu.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><GrantList CompleteYN="Y"><Grant><GrantID>P30 AG028740</GrantID><Acronym>AG</Acronym><Agency>NIA NIH HHS</Agency><Country>United States</Country></Grant></GrantList><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2020</Year><Month>04</Month><Day>19</Day></ArticleDate></Article><MedlineJournalInfo><Country>United States</Country><MedlineTA>Res Social Adm Pharm</MedlineTA><NlmUniqueID>101231974</NlmUniqueID><ISSNLinking>1551-7411</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D000998">Antiviral Agents</NameOfSubstance></Chemical><Chemical><RegistryNumber>4QWG6N8QKH</RegistryNumber><NameOfSubstance 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MajorTopicYN="N">complications</QualifierName><QualifierName UI="Q000188" MajorTopicYN="N">drug therapy</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D002738" MajorTopicYN="N">Chloroquine</DescriptorName><QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName><QualifierName UI="Q000627" MajorTopicYN="Y">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D004347" MajorTopicYN="N">Drug Interactions</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D004359" MajorTopicYN="N">Drug Therapy, Combination</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D006886" MajorTopicYN="N">Hydroxychloroquine</DescriptorName><QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName><QualifierName UI="Q000627" MajorTopicYN="Y">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D008133" MajorTopicYN="N">Long QT Syndrome</DescriptorName><QualifierName UI="Q000139" MajorTopicYN="Y">chemically induced</QualifierName><QualifierName UI="Q000401" MajorTopicYN="N">mortality</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D060735" MajorTopicYN="N">Pharmacovigilance</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D016171" MajorTopicYN="N">Torsades de Pointes</DescriptorName><QualifierName UI="Q000139" MajorTopicYN="Y">chemically induced</QualifierName><QualifierName UI="Q000401" MajorTopicYN="N">mortality</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D014481" MajorTopicYN="N" Type="Geographic">United States</DescriptorName><QualifierName UI="Q000453" MajorTopicYN="N">epidemiology</QualifierName></MeshHeading></MeshHeadingList><KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="Y">Azithromycin</Keyword><Keyword MajorTopicYN="Y">COVID-19</Keyword><Keyword MajorTopicYN="Y">Hydroxychloroquine</Keyword><Keyword 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