Global Safety Database Summary of COVID-19-Related Drug Utilization-Safety Surveillance: A Sponsor's Perspective.
Identifieur interne : 000615 ( Main/Corpus ); précédent : 000614; suivant : 000616Global Safety Database Summary of COVID-19-Related Drug Utilization-Safety Surveillance: A Sponsor's Perspective.
Auteurs : Elena Beyzarov ; Yan Chen ; Rob Julg ; Karen Naim ; Jigna Shah ; William W. Gregory ; Ayman Ayoub ; Patrick CaubelSource :
- Drug safety [ 1179-1942 ] ; 2021.
English descriptors
- KwdEn :
- Adverse Drug Reaction Reporting Systems (standards), Adverse Drug Reaction Reporting Systems (trends), Anticoagulants (adverse effects), Antimalarials (adverse effects), Antiviral Agents (adverse effects), COVID-19 (drug therapy), COVID-19 (epidemiology), Databases, Factual (standards), Databases, Factual (trends), Drug Industry (standards), Drug Industry (trends), Drug-Related Side Effects and Adverse Reactions (diagnosis), Drug-Related Side Effects and Adverse Reactions (epidemiology), Global Health (standards), Global Health (trends), Humans (MeSH), Immunosuppressive Agents (adverse effects), Pharmacovigilance (MeSH), Retrospective Studies (MeSH).
- MESH :
- chemical , adverse effects : Anticoagulants, Antimalarials, Antiviral Agents, Immunosuppressive Agents.
- diagnosis : Drug-Related Side Effects and Adverse Reactions.
- drug therapy : COVID-19.
- epidemiology : COVID-19, Drug-Related Side Effects and Adverse Reactions.
- standards : Adverse Drug Reaction Reporting Systems, Databases, Factual, Drug Industry, Global Health.
- trends : Adverse Drug Reaction Reporting Systems, Databases, Factual, Drug Industry, Global Health.
- Humans, Pharmacovigilance, Retrospective Studies.
Abstract
INTRODUCTION
Evidence-based clinical data on coronavirus disease 2019 (COVID-19) pharmacotherapies are scarce.
OBJECTIVE
This study documented and characterized COVID-19 cases reported in individuals receiving treatment with Pfizer pharmaceutical products and cases that reported use of Pfizer pharmaceutical products for COVID-19 treatment.
METHODS
This retrospective observational review leveraged the Pfizer safety database containing adverse event data collected in association with use of Pfizer products between 1 October, 2019, and 25 June, 2020; the database includes worldwide adverse event data from various sources. Selected Medical Dictionary for Drug Regulatory Activities (MedDRA
RESULTS
Over 1500 relevant cases were identified over an 8-month period. In cases that reported COVID-19, immunosuppressant/immunomodulating agents, followed by anticoagulant/antithrombic agents and corticosteroids, were the most frequently reported agents. The frequent reporting of immunosuppressant/immunomodulating agents among cases of COVID-19 suggests increased vulnerability to infection among treated patients, either because of immunosuppressive effects of certain agents or the nature of the underlying treated condition. In cases involving off-label pharmacotherapy use for the treatment of COVID-19-related conditions, the most frequently reported therapeutic classes included antibiotics, antimalarial agents, antivirals/antiretroviral agents, immunosuppressant/immunomodulating agents, corticosteroids, anticoagulants, and immunoglobulin/interferons. The most frequently reported pharmacotherapeutic agents were azithromycin and chloroquine/hydroxychloroquine, followed by lopinavir-ritonavir, ceftriaxone, and tofacitinib. The most frequently reported clinical adverse events associated with azithromycin (as sole therapy or combined with chloroquine/hydroxychloroquine) include electrocardiogram QT prolonged, drug interaction, hepatitis, diarrhea, and hepatitis acute. Regarding cardiac-related events, 19% (120/645) of azithromycin cases reported events associated with QT prolongation/torsade de pointes (which included seven fatal cardiac events). The most frequently reported clinical adverse events associated with other commonly used agents are also presented.
CONCLUSIONS
This pharmacovigilance surveillance study provides a unique characterization of cases in which a broad range of pharmaceutical products was reported in relation to COVID-19.
DOI: 10.1007/s40264-020-01035-x
PubMed: 33354753
PubMed Central: PMC7755229
Links to Exploration step
pubmed:33354753Le document en format XML
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<term>Antimalarials (adverse effects)</term>
<term>Antiviral Agents (adverse effects)</term>
<term>COVID-19 (drug therapy)</term>
<term>COVID-19 (epidemiology)</term>
<term>Databases, Factual (standards)</term>
<term>Databases, Factual (trends)</term>
<term>Drug Industry (standards)</term>
<term>Drug Industry (trends)</term>
<term>Drug-Related Side Effects and Adverse Reactions (diagnosis)</term>
<term>Drug-Related Side Effects and Adverse Reactions (epidemiology)</term>
<term>Global Health (standards)</term>
<term>Global Health (trends)</term>
<term>Humans (MeSH)</term>
<term>Immunosuppressive Agents (adverse effects)</term>
<term>Pharmacovigilance (MeSH)</term>
<term>Retrospective Studies (MeSH)</term>
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<keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en"><term>Anticoagulants</term>
<term>Antimalarials</term>
<term>Antiviral Agents</term>
<term>Immunosuppressive Agents</term>
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<keywords scheme="MESH" qualifier="epidemiology" xml:lang="en"><term>COVID-19</term>
<term>Drug-Related Side Effects and Adverse Reactions</term>
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<keywords scheme="MESH" qualifier="standards" xml:lang="en"><term>Adverse Drug Reaction Reporting Systems</term>
<term>Databases, Factual</term>
<term>Drug Industry</term>
<term>Global Health</term>
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<term>Databases, Factual</term>
<term>Drug Industry</term>
<term>Global Health</term>
</keywords>
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<term>Pharmacovigilance</term>
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<front><div type="abstract" xml:lang="en"><p><b>INTRODUCTION</b>
</p>
<p>Evidence-based clinical data on coronavirus disease 2019 (COVID-19) pharmacotherapies are scarce.</p>
</div>
<div type="abstract" xml:lang="en"><p><b>OBJECTIVE</b>
</p>
<p>This study documented and characterized COVID-19 cases reported in individuals receiving treatment with Pfizer pharmaceutical products and cases that reported use of Pfizer pharmaceutical products for COVID-19 treatment.</p>
</div>
<div type="abstract" xml:lang="en"><p><b>METHODS</b>
</p>
<p>This retrospective observational review leveraged the Pfizer safety database containing adverse event data collected in association with use of Pfizer products between 1 October, 2019, and 25 June, 2020; the database includes worldwide adverse event data from various sources. Selected Medical Dictionary for Drug Regulatory Activities (MedDRA</p>
</div>
<div type="abstract" xml:lang="en"><p><b>RESULTS</b>
</p>
<p>Over 1500 relevant cases were identified over an 8-month period. In cases that reported COVID-19, immunosuppressant/immunomodulating agents, followed by anticoagulant/antithrombic agents and corticosteroids, were the most frequently reported agents. The frequent reporting of immunosuppressant/immunomodulating agents among cases of COVID-19 suggests increased vulnerability to infection among treated patients, either because of immunosuppressive effects of certain agents or the nature of the underlying treated condition. In cases involving off-label pharmacotherapy use for the treatment of COVID-19-related conditions, the most frequently reported therapeutic classes included antibiotics, antimalarial agents, antivirals/antiretroviral agents, immunosuppressant/immunomodulating agents, corticosteroids, anticoagulants, and immunoglobulin/interferons. The most frequently reported pharmacotherapeutic agents were azithromycin and chloroquine/hydroxychloroquine, followed by lopinavir-ritonavir, ceftriaxone, and tofacitinib. The most frequently reported clinical adverse events associated with azithromycin (as sole therapy or combined with chloroquine/hydroxychloroquine) include electrocardiogram QT prolonged, drug interaction, hepatitis, diarrhea, and hepatitis acute. Regarding cardiac-related events, 19% (120/645) of azithromycin cases reported events associated with QT prolongation/torsade de pointes (which included seven fatal cardiac events). The most frequently reported clinical adverse events associated with other commonly used agents are also presented.</p>
</div>
<div type="abstract" xml:lang="en"><p><b>CONCLUSIONS</b>
</p>
<p>This pharmacovigilance surveillance study provides a unique characterization of cases in which a broad range of pharmaceutical products was reported in relation to COVID-19.</p>
</div>
</front>
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<Abstract><AbstractText Label="INTRODUCTION">Evidence-based clinical data on coronavirus disease 2019 (COVID-19) pharmacotherapies are scarce.</AbstractText>
<AbstractText Label="OBJECTIVE">This study documented and characterized COVID-19 cases reported in individuals receiving treatment with Pfizer pharmaceutical products and cases that reported use of Pfizer pharmaceutical products for COVID-19 treatment.</AbstractText>
<AbstractText Label="METHODS">This retrospective observational review leveraged the Pfizer safety database containing adverse event data collected in association with use of Pfizer products between 1 October, 2019, and 25 June, 2020; the database includes worldwide adverse event data from various sources. Selected Medical Dictionary for Drug Regulatory Activities (MedDRA<sup>®</sup>
) Preferred Terms and subsequent clinical review were used to characterize COVID-19 cases.</AbstractText>
<AbstractText Label="RESULTS">Over 1500 relevant cases were identified over an 8-month period. In cases that reported COVID-19, immunosuppressant/immunomodulating agents, followed by anticoagulant/antithrombic agents and corticosteroids, were the most frequently reported agents. The frequent reporting of immunosuppressant/immunomodulating agents among cases of COVID-19 suggests increased vulnerability to infection among treated patients, either because of immunosuppressive effects of certain agents or the nature of the underlying treated condition. In cases involving off-label pharmacotherapy use for the treatment of COVID-19-related conditions, the most frequently reported therapeutic classes included antibiotics, antimalarial agents, antivirals/antiretroviral agents, immunosuppressant/immunomodulating agents, corticosteroids, anticoagulants, and immunoglobulin/interferons. The most frequently reported pharmacotherapeutic agents were azithromycin and chloroquine/hydroxychloroquine, followed by lopinavir-ritonavir, ceftriaxone, and tofacitinib. The most frequently reported clinical adverse events associated with azithromycin (as sole therapy or combined with chloroquine/hydroxychloroquine) include electrocardiogram QT prolonged, drug interaction, hepatitis, diarrhea, and hepatitis acute. Regarding cardiac-related events, 19% (120/645) of azithromycin cases reported events associated with QT prolongation/torsade de pointes (which included seven fatal cardiac events). The most frequently reported clinical adverse events associated with other commonly used agents are also presented.</AbstractText>
<AbstractText Label="CONCLUSIONS">This pharmacovigilance surveillance study provides a unique characterization of cases in which a broad range of pharmaceutical products was reported in relation to COVID-19.</AbstractText>
</Abstract>
<AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Beyzarov</LastName>
<ForeName>Elena</ForeName>
<Initials>E</Initials>
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<AffiliationInfo><Affiliation>Worldwide Medical and Safety, Worldwide Research and Development, Pfizer Inc, 100 US-206, Peapack, NJ, 07977, USA. Elena.Beyzarov@pfizer.com.</Affiliation>
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<Author ValidYN="Y"><LastName>Chen</LastName>
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</AffiliationInfo>
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<Author ValidYN="Y"><LastName>Julg</LastName>
<ForeName>Rob</ForeName>
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<AffiliationInfo><Affiliation>Information Management Operations Center of Excellence, Global Product Development Pfizer Inc, Peapack, NJ, USA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Naim</LastName>
<ForeName>Karen</ForeName>
<Initials>K</Initials>
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</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Shah</LastName>
<ForeName>Jigna</ForeName>
<Initials>J</Initials>
<AffiliationInfo><Affiliation>Worldwide Medical and Safety, Worldwide Research and Development, Pfizer Inc, 100 US-206, Peapack, NJ, 07977, USA.</Affiliation>
</AffiliationInfo>
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<Author ValidYN="Y"><LastName>Gregory</LastName>
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</AffiliationInfo>
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<Author ValidYN="Y"><LastName>Ayoub</LastName>
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</AffiliationInfo>
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