Pharmacotherapy Management for COVID-19 and Cardiac Safety: A Data Mining Approach for Pharmacovigilance Evidence from the FDA Adverse Event Reporting System (FAERS).
Identifieur interne : 000274 ( Main/Exploration ); précédent : 000273; suivant : 000275Pharmacotherapy Management for COVID-19 and Cardiac Safety: A Data Mining Approach for Pharmacovigilance Evidence from the FDA Adverse Event Reporting System (FAERS).
Auteurs : Jing Yuan [République populaire de Chine] ; Minghui Li [États-Unis] ; Yiqun Yu [République populaire de Chine] ; Tai-Ying Lee [États-Unis] ; Gang Lv [République populaire de Chine] ; Bing Han [République populaire de Chine] ; Xiaoqiang Xiang [République populaire de Chine] ; Z Kevin Lu [États-Unis]Source :
- Drugs - real world outcomes [ 2199-1154 ] ; 2021.
Abstract
BACKGROUND
Several pharmacological agents, such as chloroquine/hydroxychloroquine, have been promoted for COVID-19 treatment or pre-exposure prophylaxis. However, no comprehensive evaluation of the safety of these possible agents is available, and is urgently needed.
OBJECTIVE
The purpose of this study was to investigate the risks of cardiac adverse events associated with the possible pharmacotherapies for COVID-19, including certain antimalarial, antiviral, and antibiotic drugs.
PATIENTS AND METHODS
We conduced retrospective pharmacovigilance analyses of the US Food and Drug Administration Adverse Event Reporting System database. The reporting odds ratio (ROR), a data mining algorithm commonly used in pharmacovigilance assessment, was generated to quantify the detection signal of adverse events.
RESULTS
Among individuals without coronavirus infection from 2015 Q1 to 2020 Q1, increased risks for cardiac disorders were found for antiviral agents such as chloroquine/hydroxychloroquine (ROR: 1.68; 95% confidence interval [CI] 1.66-1.70), lopinavir/ritonavir (ROR: 1.52; 95% CI 1.39-1.66), and antibiotics such as azithromycin (ROR: 1.37; 95% CI 1.30-1.44) and ceftriaxone (ROR: 1.92; 95% CI 1.80-2.05). Increased serious cardiac adverse events, including myocardial infarction, arrhythmia, and cardiac arrest, were also reported for these drugs. Further analyses of individuals with coronavirus infections revealed that 40% of individuals receiving chloroquine/hydroxychloroquine reported serious cardiac adverse events. Two cases resulted in QT prolongations and one case resulted in cardiac arrest. Chloroquine/hydroxychloroquine and azithromycin contributed to all the QT prolongation and cardiac arrest cases.
CONCLUSIONS
The current pharmacotherapies for COVID-19 are associated with increased risks of cardiac adverse events. Variations in the cardiac safety profiles of these pharmacotherapies were also observed. Clinicians should closely monitor patients with COVID-19, especially those at high risk, using chloroquine/hydroxychloroquine and azithromycin.
DOI: 10.1007/s40801-021-00229-8
PubMed: 33569736
PubMed Central: PMC7875167
Affiliations:
- République populaire de Chine, États-Unis
- Caroline du Sud, Tennessee
- Columbia (Caroline du Sud), Pékin
- Université de Caroline du Sud
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wicri:level="2"><nlm:affiliation>University of Tennessee Health Science Center, Memphis, TN, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>University of Tennessee Health Science Center, Memphis, TN</wicri:regionArea><placeName><region type="state">Tennessee</region></placeName></affiliation></author><author><name sortKey="Yu, Yiqun" sort="Yu, Yiqun" uniqKey="Yu Y" first="Yiqun" last="Yu">Yiqun Yu</name><affiliation wicri:level="1"><nlm:affiliation>Department of Pharmacy, Minhang Hospital, Fudan University, Shanghai, People's Republic of China.</nlm:affiliation><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>Department of Pharmacy, Minhang Hospital, Fudan University, Shanghai</wicri:regionArea><wicri:noRegion>Shanghai</wicri:noRegion></affiliation></author><author><name sortKey="Lee, Tai Ying" sort="Lee, Tai Ying" uniqKey="Lee T" first="Tai-Ying" last="Lee">Tai-Ying Lee</name><affiliation wicri:level="4"><nlm:affiliation>University of South Carolina, 715 Sumter Street, CLS Building 311, Columbia, SC, 29208, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>University of South Carolina, 715 Sumter Street, CLS Building 311, Columbia, SC, 29208</wicri:regionArea><orgName type="university">Université de Caroline du Sud</orgName><placeName><settlement type="city">Columbia (Caroline du Sud)</settlement><region type="state">Caroline du Sud</region></placeName></affiliation></author><author><name sortKey="Lv, Gang" sort="Lv, Gang" uniqKey="Lv G" first="Gang" last="Lv">Gang Lv</name><affiliation wicri:level="3"><nlm:affiliation>General Surgery Department, 1st Medical Center of PLA General Hospital, Beijing, China.</nlm:affiliation><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>General Surgery Department, 1st Medical Center of PLA General Hospital, Beijing</wicri:regionArea><placeName><settlement type="city">Pékin</settlement></placeName></affiliation></author><author><name sortKey="Han, Bing" sort="Han, Bing" uniqKey="Han B" first="Bing" last="Han">Bing Han</name><affiliation wicri:level="1"><nlm:affiliation>Department of Pharmacy, Minhang Hospital, Fudan University, Shanghai, People's Republic of China.</nlm:affiliation><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>Department of Pharmacy, Minhang Hospital, Fudan University, Shanghai</wicri:regionArea><wicri:noRegion>Shanghai</wicri:noRegion></affiliation></author><author><name sortKey="Xiang, Xiaoqiang" sort="Xiang, Xiaoqiang" uniqKey="Xiang X" first="Xiaoqiang" last="Xiang">Xiaoqiang Xiang</name><affiliation wicri:level="1"><nlm:affiliation>Department of Clinical Pharmacy, School of Pharmacy, Fudan University, 826 Zhangheng Road, Pudong, Shanghai, 201203, People's Republic of China. xiangxq@fudan.edu.cn.</nlm:affiliation><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>Department of Clinical Pharmacy, School of Pharmacy, Fudan University, 826 Zhangheng Road, Pudong, Shanghai, 201203</wicri:regionArea><wicri:noRegion>201203</wicri:noRegion></affiliation></author><author><name sortKey="Lu, Z Kevin" sort="Lu, Z Kevin" uniqKey="Lu Z" first="Z Kevin" last="Lu">Z Kevin Lu</name><affiliation wicri:level="4"><nlm:affiliation>University of South Carolina, 715 Sumter Street, CLS Building 311, Columbia, SC, 29208, USA. lu32@email.sc.edu.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>University of South Carolina, 715 Sumter Street, CLS Building 311, Columbia, SC, 29208</wicri:regionArea><orgName type="university">Université de Caroline du Sud</orgName><placeName><settlement type="city">Columbia (Caroline du Sud)</settlement><region type="state">Caroline du Sud</region></placeName></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2021">2021</date><idno type="RBID">pubmed:33569736</idno><idno type="pmid">33569736</idno><idno type="doi">10.1007/s40801-021-00229-8</idno><idno type="pmc">PMC7875167</idno><idno type="wicri:Area/Main/Corpus">000353</idno><idno type="wicri:explorRef" wicri:stream="Main" wicri:step="Corpus" wicri:corpus="PubMed">000353</idno><idno type="wicri:Area/Main/Curation">000353</idno><idno type="wicri:explorRef" wicri:stream="Main" wicri:step="Curation">000353</idno><idno type="wicri:Area/Main/Exploration">000353</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Pharmacotherapy Management for COVID-19 and Cardiac Safety: A Data Mining Approach for Pharmacovigilance Evidence from the FDA Adverse Event Reporting System (FAERS).</title><author><name sortKey="Yuan, Jing" sort="Yuan, Jing" uniqKey="Yuan J" first="Jing" last="Yuan">Jing Yuan</name><affiliation wicri:level="1"><nlm:affiliation>Department of Clinical Pharmacy, School of Pharmacy, Fudan University, 826 Zhangheng Road, Pudong, Shanghai, 201203, People's Republic of China.</nlm:affiliation><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>Department of Clinical Pharmacy, School of Pharmacy, Fudan University, 826 Zhangheng Road, Pudong, Shanghai, 201203</wicri:regionArea><wicri:noRegion>201203</wicri:noRegion></affiliation></author><author><name sortKey="Li, Minghui" sort="Li, Minghui" uniqKey="Li M" first="Minghui" last="Li">Minghui Li</name><affiliation wicri:level="2"><nlm:affiliation>University of Tennessee Health Science Center, Memphis, TN, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>University of Tennessee Health Science Center, Memphis, TN</wicri:regionArea><placeName><region type="state">Tennessee</region></placeName></affiliation></author><author><name sortKey="Yu, Yiqun" sort="Yu, Yiqun" uniqKey="Yu Y" first="Yiqun" last="Yu">Yiqun Yu</name><affiliation wicri:level="1"><nlm:affiliation>Department of Pharmacy, Minhang Hospital, Fudan University, Shanghai, People's Republic of China.</nlm:affiliation><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>Department of Pharmacy, Minhang Hospital, Fudan University, Shanghai</wicri:regionArea><wicri:noRegion>Shanghai</wicri:noRegion></affiliation></author><author><name sortKey="Lee, Tai Ying" sort="Lee, Tai Ying" uniqKey="Lee T" first="Tai-Ying" last="Lee">Tai-Ying Lee</name><affiliation wicri:level="4"><nlm:affiliation>University of South Carolina, 715 Sumter Street, CLS Building 311, Columbia, SC, 29208, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>University of South Carolina, 715 Sumter Street, CLS Building 311, Columbia, SC, 29208</wicri:regionArea><orgName type="university">Université de Caroline du Sud</orgName><placeName><settlement type="city">Columbia (Caroline du Sud)</settlement><region type="state">Caroline du Sud</region></placeName></affiliation></author><author><name sortKey="Lv, Gang" sort="Lv, Gang" uniqKey="Lv G" first="Gang" last="Lv">Gang Lv</name><affiliation wicri:level="3"><nlm:affiliation>General Surgery Department, 1st Medical Center of PLA General Hospital, Beijing, China.</nlm:affiliation><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>General Surgery Department, 1st Medical Center of PLA General Hospital, Beijing</wicri:regionArea><placeName><settlement type="city">Pékin</settlement></placeName></affiliation></author><author><name sortKey="Han, Bing" sort="Han, Bing" uniqKey="Han B" first="Bing" last="Han">Bing Han</name><affiliation wicri:level="1"><nlm:affiliation>Department of Pharmacy, Minhang Hospital, Fudan University, Shanghai, People's Republic of China.</nlm:affiliation><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>Department of Pharmacy, Minhang Hospital, Fudan University, Shanghai</wicri:regionArea><wicri:noRegion>Shanghai</wicri:noRegion></affiliation></author><author><name sortKey="Xiang, Xiaoqiang" sort="Xiang, Xiaoqiang" uniqKey="Xiang X" first="Xiaoqiang" last="Xiang">Xiaoqiang Xiang</name><affiliation wicri:level="1"><nlm:affiliation>Department of Clinical Pharmacy, School of Pharmacy, Fudan University, 826 Zhangheng Road, Pudong, Shanghai, 201203, People's Republic of China. xiangxq@fudan.edu.cn.</nlm:affiliation><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>Department of Clinical Pharmacy, School of Pharmacy, Fudan University, 826 Zhangheng Road, Pudong, Shanghai, 201203</wicri:regionArea><wicri:noRegion>201203</wicri:noRegion></affiliation></author><author><name sortKey="Lu, Z Kevin" sort="Lu, Z Kevin" uniqKey="Lu Z" first="Z Kevin" last="Lu">Z Kevin Lu</name><affiliation wicri:level="4"><nlm:affiliation>University of South Carolina, 715 Sumter Street, CLS Building 311, Columbia, SC, 29208, USA. lu32@email.sc.edu.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>University of South Carolina, 715 Sumter Street, CLS Building 311, Columbia, SC, 29208</wicri:regionArea><orgName type="university">Université de Caroline du Sud</orgName><placeName><settlement type="city">Columbia (Caroline du Sud)</settlement><region type="state">Caroline du Sud</region></placeName></affiliation></author></analytic><series><title level="j">Drugs - real world outcomes</title><idno type="ISSN">2199-1154</idno><imprint><date when="2021" type="published">2021</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><p><b>BACKGROUND</b></p><p>Several pharmacological agents, such as chloroquine/hydroxychloroquine, have been promoted for COVID-19 treatment or pre-exposure prophylaxis. However, no comprehensive evaluation of the safety of these possible agents is available, and is urgently needed.</p></div><div type="abstract" xml:lang="en"><p><b>OBJECTIVE</b></p><p>The purpose of this study was to investigate the risks of cardiac adverse events associated with the possible pharmacotherapies for COVID-19, including certain antimalarial, antiviral, and antibiotic drugs.</p></div><div type="abstract" xml:lang="en"><p><b>PATIENTS AND METHODS</b></p><p>We conduced retrospective pharmacovigilance analyses of the US Food and Drug Administration Adverse Event Reporting System database. The reporting odds ratio (ROR), a data mining algorithm commonly used in pharmacovigilance assessment, was generated to quantify the detection signal of adverse events.</p></div><div type="abstract" xml:lang="en"><p><b>RESULTS</b></p><p>Among individuals without coronavirus infection from 2015 Q1 to 2020 Q1, increased risks for cardiac disorders were found for antiviral agents such as chloroquine/hydroxychloroquine (ROR: 1.68; 95% confidence interval [CI] 1.66-1.70), lopinavir/ritonavir (ROR: 1.52; 95% CI 1.39-1.66), and antibiotics such as azithromycin (ROR: 1.37; 95% CI 1.30-1.44) and ceftriaxone (ROR: 1.92; 95% CI 1.80-2.05). Increased serious cardiac adverse events, including myocardial infarction, arrhythmia, and cardiac arrest, were also reported for these drugs. Further analyses of individuals with coronavirus infections revealed that 40% of individuals receiving chloroquine/hydroxychloroquine reported serious cardiac adverse events. Two cases resulted in QT prolongations and one case resulted in cardiac arrest. Chloroquine/hydroxychloroquine and azithromycin contributed to all the QT prolongation and cardiac arrest cases.</p></div><div type="abstract" xml:lang="en"><p><b>CONCLUSIONS</b></p><p>The current pharmacotherapies for COVID-19 are associated with increased risks of cardiac adverse events. Variations in the cardiac safety profiles of these pharmacotherapies were also observed. Clinicians should closely monitor patients with COVID-19, especially those at high risk, using chloroquine/hydroxychloroquine and azithromycin.</p></div></front></TEI><pubmed><MedlineCitation Status="PubMed-not-MEDLINE" Owner="NLM"><PMID Version="1">33569736</PMID><DateRevised><Year>2021</Year><Month>05</Month><Day>18</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Print">2199-1154</ISSN><JournalIssue CitedMedium="Print"><Volume>8</Volume><Issue>2</Issue><PubDate><Year>2021</Year><Month>Jun</Month></PubDate></JournalIssue><Title>Drugs - real world outcomes</Title><ISOAbbreviation>Drugs Real World Outcomes</ISOAbbreviation></Journal><ArticleTitle>Pharmacotherapy Management for COVID-19 and Cardiac Safety: A Data Mining Approach for Pharmacovigilance Evidence from the FDA Adverse Event Reporting System (FAERS).</ArticleTitle><Pagination><MedlinePgn>131-140</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1007/s40801-021-00229-8</ELocationID><Abstract><AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">Several pharmacological agents, such as chloroquine/hydroxychloroquine, have been promoted for COVID-19 treatment or pre-exposure prophylaxis. However, no comprehensive evaluation of the safety of these possible agents is available, and is urgently needed.</AbstractText><AbstractText Label="OBJECTIVE" NlmCategory="OBJECTIVE">The purpose of this study was to investigate the risks of cardiac adverse events associated with the possible pharmacotherapies for COVID-19, including certain antimalarial, antiviral, and antibiotic drugs.</AbstractText><AbstractText Label="PATIENTS AND METHODS" NlmCategory="METHODS">We conduced retrospective pharmacovigilance analyses of the US Food and Drug Administration Adverse Event Reporting System database. The reporting odds ratio (ROR), a data mining algorithm commonly used in pharmacovigilance assessment, was generated to quantify the detection signal of adverse events.</AbstractText><AbstractText Label="RESULTS" NlmCategory="RESULTS">Among individuals without coronavirus infection from 2015 Q1 to 2020 Q1, increased risks for cardiac disorders were found for antiviral agents such as chloroquine/hydroxychloroquine (ROR: 1.68; 95% confidence interval [CI] 1.66-1.70), lopinavir/ritonavir (ROR: 1.52; 95% CI 1.39-1.66), and antibiotics such as azithromycin (ROR: 1.37; 95% CI 1.30-1.44) and ceftriaxone (ROR: 1.92; 95% CI 1.80-2.05). Increased serious cardiac adverse events, including myocardial infarction, arrhythmia, and cardiac arrest, were also reported for these drugs. Further analyses of individuals with coronavirus infections revealed that 40% of individuals receiving chloroquine/hydroxychloroquine reported serious cardiac adverse events. Two cases resulted in QT prolongations and one case resulted in cardiac arrest. Chloroquine/hydroxychloroquine and azithromycin contributed to all the QT prolongation and cardiac arrest cases.</AbstractText><AbstractText Label="CONCLUSIONS" NlmCategory="CONCLUSIONS">The current pharmacotherapies for COVID-19 are associated with increased risks of cardiac adverse events. Variations in the cardiac safety profiles of these pharmacotherapies were also observed. Clinicians should closely monitor patients with COVID-19, especially those at high risk, using chloroquine/hydroxychloroquine and azithromycin.</AbstractText></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y" EqualContrib="Y"><LastName>Yuan</LastName><ForeName>Jing</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>Department of Clinical Pharmacy, School of Pharmacy, Fudan University, 826 Zhangheng Road, Pudong, Shanghai, 201203, People's Republic of China.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y" EqualContrib="Y"><LastName>Li</LastName><ForeName>Minghui</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>University of Tennessee Health Science Center, Memphis, TN, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y" EqualContrib="Y"><LastName>Yu</LastName><ForeName>Yiqun</ForeName><Initials>Y</Initials><AffiliationInfo><Affiliation>Department of Pharmacy, Minhang Hospital, Fudan University, Shanghai, People's Republic of China.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Lee</LastName><ForeName>Tai-Ying</ForeName><Initials>TY</Initials><AffiliationInfo><Affiliation>University of South Carolina, 715 Sumter Street, CLS Building 311, Columbia, SC, 29208, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Lv</LastName><ForeName>Gang</ForeName><Initials>G</Initials><AffiliationInfo><Affiliation>General Surgery Department, 1st Medical Center of PLA General Hospital, Beijing, China.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y" EqualContrib="Y"><LastName>Han</LastName><ForeName>Bing</ForeName><Initials>B</Initials><AffiliationInfo><Affiliation>Department of Pharmacy, Minhang Hospital, Fudan University, Shanghai, People's Republic of China.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Xiang</LastName><ForeName>Xiaoqiang</ForeName><Initials>X</Initials><AffiliationInfo><Affiliation>Department of Clinical Pharmacy, School of Pharmacy, Fudan University, 826 Zhangheng Road, Pudong, Shanghai, 201203, People's Republic of China. xiangxq@fudan.edu.cn.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Lu</LastName><ForeName>Z Kevin</ForeName><Initials>ZK</Initials><AffiliationInfo><Affiliation>University of South Carolina, 715 Sumter Street, CLS Building 311, Columbia, SC, 29208, USA. lu32@email.sc.edu.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2021</Year><Month>02</Month><Day>10</Day></ArticleDate></Article><MedlineJournalInfo><Country>Switzerland</Country><MedlineTA>Drugs Real World Outcomes</MedlineTA><NlmUniqueID>101658456</NlmUniqueID><ISSNLinking>2198-9788</ISSNLinking></MedlineJournalInfo></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="accepted"><Year>2021</Year><Month>01</Month><Day>18</Day></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2021</Year><Month>2</Month><Day>12</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2021</Year><Month>2</Month><Day>12</Day><Hour>6</Hour><Minute>1</Minute></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2021</Year><Month>2</Month><Day>11</Day><Hour>5</Hour><Minute>57</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">33569736</ArticleId><ArticleId IdType="doi">10.1007/s40801-021-00229-8</ArticleId><ArticleId IdType="pii">10.1007/s40801-021-00229-8</ArticleId><ArticleId IdType="pmc">PMC7875167</ArticleId></ArticleIdList><ReferenceList><Reference><Citation>World Health Organization. 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