Safety profile of oseltamivir during the 2009 influenza pandemic.
Identifieur interne : 001006 ( Ncbi/Merge ); précédent : 001005; suivant : 001007Safety profile of oseltamivir during the 2009 influenza pandemic.
Auteurs : Barbara Donner [Suisse] ; Silvia Bader-Weder ; Roman Schwarz ; Michael M. Peng ; James Robert Smith ; Viswanathan NiranjanSource :
- Pharmacoepidemiology and drug safety [ 1099-1557 ] ; 2011.
Descripteurs français
- KwdFr :
- Adulte, Adulte d'âge moyen, Antiviraux (administration et posologie), Antiviraux (effets indésirables), Antiviraux (usage thérapeutique), Enfant, Enfant d'âge préscolaire, Erreurs de médication (), Femelle, Grippe humaine (traitement médicamenteux), Grippe humaine (épidémiologie), Humains, Japon (épidémiologie), Jeune adulte, Mâle, Nourrisson, Nouveau-né, Oséltamivir (administration et posologie), Oséltamivir (effets indésirables), Oséltamivir (usage thérapeutique), Pandémies (), Sujet âgé, Systèmes de signalement des effets indésirables des médicaments, États-Unis d'Amérique (épidémiologie).
- MESH :
- administration et posologie : Antiviraux, Oséltamivir.
- effets indésirables : Antiviraux, Oséltamivir.
- traitement médicamenteux : Grippe humaine.
- usage thérapeutique : Antiviraux, Oséltamivir.
- épidémiologie : Grippe humaine, Japon, États-Unis d'Amérique.
- Adulte, Adulte d'âge moyen, Enfant, Enfant d'âge préscolaire, Erreurs de médication, Femelle, Humains, Jeune adulte, Mâle, Nourrisson, Nouveau-né, Pandémies, Sujet âgé, Systèmes de signalement des effets indésirables des médicaments.
- Wicri :
- geographic : Japon, États-Unis.
English descriptors
- KwdEn :
- Adult, Adverse Drug Reaction Reporting Systems, Aged, Antiviral Agents (administration & dosage), Antiviral Agents (adverse effects), Antiviral Agents (therapeutic use), Child, Child, Preschool, Female, Humans, Infant, Infant, Newborn, Influenza, Human (drug therapy), Influenza, Human (epidemiology), Japan (epidemiology), Male, Medication Errors (statistics & numerical data), Middle Aged, Oseltamivir (administration & dosage), Oseltamivir (adverse effects), Oseltamivir (therapeutic use), Pandemics (prevention & control), Pandemics (statistics & numerical data), United States (epidemiology), Young Adult.
- MESH :
- chemical , administration & dosage : Antiviral Agents, Oseltamivir.
- chemical , adverse effects : Antiviral Agents, Oseltamivir.
- chemical , therapeutic use : Antiviral Agents, Oseltamivir.
- geographic , epidemiology : Japan, United States.
- drug therapy : Influenza, Human.
- epidemiology : Influenza, Human.
- prevention & control : Pandemics.
- statistics & numerical data : Medication Errors, Pandemics.
- Adult, Adverse Drug Reaction Reporting Systems, Aged, Child, Child, Preschool, Female, Humans, Infant, Infant, Newborn, Male, Middle Aged, Young Adult.
Abstract
This study evaluated the safety of oseltamivir during the 2009 influenza pandemic.
DOI: 10.1002/pds.2136
PubMed: 21448900
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pubmed:21448900Le document en format XML
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(épidémiologie)</term><term>Humains</term><term>Japon (épidémiologie)</term><term>Jeune adulte</term><term>Mâle</term><term>Nourrisson</term><term>Nouveau-né</term><term>Oséltamivir (administration et posologie)</term><term>Oséltamivir (effets indésirables)</term><term>Oséltamivir (usage thérapeutique)</term><term>Pandémies ()</term><term>Sujet âgé</term><term>Systèmes de signalement des effets indésirables des médicaments</term><term>États-Unis d'Amérique (épidémiologie)</term></keywords><keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en"><term>Antiviral Agents</term><term>Oseltamivir</term></keywords><keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en"><term>Antiviral Agents</term><term>Oseltamivir</term></keywords><keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Antiviral Agents</term><term>Oseltamivir</term></keywords><keywords scheme="MESH" type="geographic" 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médicaments</term></keywords><keywords scheme="Wicri" type="geographic" xml:lang="fr"><term>Japon</term><term>États-Unis</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">This study evaluated the safety of oseltamivir during the 2009 influenza pandemic.</div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">21448900</PMID><DateCompleted><Year>2011</Year><Month>09</Month><Day>02</Day></DateCompleted><DateRevised><Year>2013</Year><Month>11</Month><Day>21</Day></DateRevised><Article PubModel="Print"><Journal><ISSN IssnType="Electronic">1099-1557</ISSN><JournalIssue CitedMedium="Internet"><Volume>20</Volume><Issue>5</Issue><PubDate><Year>2011</Year><Month>May</Month></PubDate></JournalIssue><Title>Pharmacoepidemiology and drug safety</Title><ISOAbbreviation>Pharmacoepidemiol Drug Saf</ISOAbbreviation></Journal><ArticleTitle>Safety profile of oseltamivir during the 2009 influenza pandemic.</ArticleTitle><Pagination><MedlinePgn>532-43</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1002/pds.2136</ELocationID><Abstract><AbstractText Label="PURPOSE" NlmCategory="OBJECTIVE">This study evaluated the safety of oseltamivir during the 2009 influenza pandemic.</AbstractText><AbstractText Label="METHODS" NlmCategory="METHODS">Case reports were obtained from the Roche safety database. The incidence of adverse events (AEs) during the pandemic (1 May 2009 to 31 December 2009) was compared with that beforehand (during previous influenza seasons) for USA and Japan only, as exposure data in other countries were collected inconsistently. Events with significantly higher reporting during the pandemic (lower bound of 95%CI for crude rate ratio >1) were analyzed further.</AbstractText><AbstractText Label="RESULTS" NlmCategory="RESULTS">Global exposure in the pandemic and prepandemic periods was 18.3 and 64.7 million patients, respectively. In USA and Japan, exposure was 15.5 (1382 cases, 2225 events) and 62.0 million (8387 cases, 12,749 events), respectively. AEs with significantly higher reporting during the pandemic were generally consistent with influenza and its complications and/or with the circulation of a novel virus strain. As might be expected in a pandemic, mortality increased (crude rate ratio, 2.83; 95%CI, 2.23-3.59) versus the prepandemic period. Medical review of serious AEs (fatal or non-fatal outcome) found that most were consistent with pre-existing risk factors, underlying disease, and/or progression of influenza or its complications. Analysis of the remainder did not suggest a causal link with oseltamivir. A review of AEs in previously underexposed subpopulations did not support an association with oseltamivir.</AbstractText><AbstractText Label="CONCLUSIONS" NlmCategory="CONCLUSIONS">During the first 8 months of the 2009 influenza pandemic, AEs reported in patients exposed to oseltamivir were consistent with the drug's labeled safety profile, underlying medical conditions, or infection with the pandemic virus.</AbstractText><CopyrightInformation>Copyright © 2011 John Wiley & Sons, Ltd.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Donner</LastName><ForeName>Barbara</ForeName><Initials>B</Initials><AffiliationInfo><Affiliation>F. Hoffmann-La Roche Ltd, Basel, Switzerland. barbara.donner@roche.com</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Bader-Weder</LastName><ForeName>Silvia</ForeName><Initials>S</Initials></Author><Author ValidYN="Y"><LastName>Schwarz</LastName><ForeName>Roman</ForeName><Initials>R</Initials></Author><Author ValidYN="Y"><LastName>Peng</LastName><ForeName>Michael M</ForeName><Initials>MM</Initials></Author><Author ValidYN="Y"><LastName>Smith</LastName><ForeName>James Robert</ForeName><Initials>JR</Initials></Author><Author ValidYN="Y"><LastName>Niranjan</LastName><ForeName>Viswanathan</ForeName><Initials>V</Initials></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D013485">Research Support, Non-U.S. Gov't</PublicationType></PublicationTypeList></Article><MedlineJournalInfo><Country>England</Country><MedlineTA>Pharmacoepidemiol Drug Saf</MedlineTA><NlmUniqueID>9208369</NlmUniqueID><ISSNLinking>1053-8569</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D000998">Antiviral Agents</NameOfSubstance></Chemical><Chemical><RegistryNumber>20O93L6F9H</RegistryNumber><NameOfSubstance UI="D053139">Oseltamivir</NameOfSubstance></Chemical></ChemicalList><CitationSubset>IM</CitationSubset><MeshHeadingList><MeshHeading><DescriptorName UI="D000328" MajorTopicYN="N">Adult</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D016907" MajorTopicYN="Y">Adverse Drug Reaction Reporting Systems</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000368" MajorTopicYN="N">Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000998" MajorTopicYN="N">Antiviral Agents</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="N">administration & dosage</QualifierName><QualifierName UI="Q000009" MajorTopicYN="Y">adverse effects</QualifierName><QualifierName UI="Q000627" MajorTopicYN="N">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D002648" MajorTopicYN="N">Child</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D002675" MajorTopicYN="N">Child, Preschool</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D005260" MajorTopicYN="N">Female</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D007223" MajorTopicYN="N">Infant</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D007231" MajorTopicYN="N">Infant, Newborn</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D007251" MajorTopicYN="N">Influenza, Human</DescriptorName><QualifierName UI="Q000188" MajorTopicYN="Y">drug therapy</QualifierName><QualifierName UI="Q000453" MajorTopicYN="N">epidemiology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D007564" MajorTopicYN="N" Type="Geographic">Japan</DescriptorName><QualifierName UI="Q000453" MajorTopicYN="N">epidemiology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D008297" MajorTopicYN="N">Male</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D008508" MajorTopicYN="N">Medication Errors</DescriptorName><QualifierName UI="Q000706" MajorTopicYN="N">statistics & numerical data</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D008875" MajorTopicYN="N">Middle Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D053139" MajorTopicYN="N">Oseltamivir</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="N">administration & dosage</QualifierName><QualifierName UI="Q000009" MajorTopicYN="Y">adverse effects</QualifierName><QualifierName UI="Q000627" MajorTopicYN="N">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D058873" MajorTopicYN="Y">Pandemics</DescriptorName><QualifierName UI="Q000517" MajorTopicYN="N">prevention & control</QualifierName><QualifierName UI="Q000706" MajorTopicYN="N">statistics & numerical data</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D014481" MajorTopicYN="N" Type="Geographic">United States</DescriptorName><QualifierName UI="Q000453" MajorTopicYN="N">epidemiology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D055815" MajorTopicYN="N">Young Adult</DescriptorName></MeshHeading></MeshHeadingList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="entrez"><Year>2011</Year><Month>3</Month><Day>31</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2011</Year><Month>3</Month><Day>31</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2011</Year><Month>9</Month><Day>3</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">21448900</ArticleId><ArticleId IdType="doi">10.1002/pds.2136</ArticleId></ArticleIdList></PubmedData></pubmed><affiliations><list><country><li>Suisse</li></country></list><tree><noCountry><name sortKey="Bader Weder, Silvia" sort="Bader Weder, Silvia" uniqKey="Bader Weder S" first="Silvia" last="Bader-Weder">Silvia Bader-Weder</name><name sortKey="Niranjan, Viswanathan" sort="Niranjan, Viswanathan" uniqKey="Niranjan V" first="Viswanathan" last="Niranjan">Viswanathan Niranjan</name><name sortKey="Peng, Michael M" sort="Peng, Michael M" uniqKey="Peng M" first="Michael M" last="Peng">Michael M. Peng</name><name sortKey="Schwarz, Roman" sort="Schwarz, Roman" uniqKey="Schwarz R" first="Roman" last="Schwarz">Roman Schwarz</name><name sortKey="Smith, James Robert" sort="Smith, James Robert" uniqKey="Smith J" first="James Robert" last="Smith">James Robert Smith</name></noCountry><country name="Suisse"><noRegion><name sortKey="Donner, Barbara" sort="Donner, Barbara" uniqKey="Donner B" first="Barbara" last="Donner">Barbara Donner</name></noRegion></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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