Pregnancy outcomes after maternal varenicline use; analysis of surveillance data collected by the European Network of Teratology Information Services.
Identifieur interne : 001332 ( PubMed/Curation ); précédent : 001331; suivant : 001333Pregnancy outcomes after maternal varenicline use; analysis of surveillance data collected by the European Network of Teratology Information Services.
Auteurs : J L Richardson [Royaume-Uni] ; S. Stephens [Royaume-Uni] ; L M Yates [Royaume-Uni] ; O. Diav-Citrin [Israël] ; J. Arnon [Israël] ; D. Beghin [France] ; A. Kayser [Allemagne] ; D. Kennedy [Australie] ; D. Cupitt [Australie] ; B. Te Winkel [Pays-Bas] ; M. Peltonen [Finlande] ; Y C Kaplan [Turquie] ; S H L. Thomas [Royaume-Uni]Source :
- Reproductive toxicology (Elmsford, N.Y.) [ 1873-1708 ] ; 2017.
Abstract
Varenicline is a smoking cessation aid for which limited data exist concerning safety during human pregnancy. This multicentre prospective observational comparative cohort study was undertaken using surveillance data collected by the European Network of Teratology Information Services. The study sample consisted of 89 varenicline exposed pregnancies and two matched comparator groups; 267 non-teratogen exposed (NTE) controls and 78 exposed to nicotine replacement therapy or bupropion (NRT/B) for smoking cessation. For all exposed pregnancies, varenicline use only occurred in the first trimester, with a considerable proportion discontinuing use in the very early stages of pregnancy. The major congenital malformation rate (n=2/89, 2.25%) was in keeping with the expected background rate (2-4%), and was not significantly increased for first trimester varenicline-exposed infants in comparison with non-exposed controls (vs. NTE: OR 2.02, 95%CI 0.166 to 17.9, vs.
DOI: 10.1016/j.reprotox.2016.11.010
PubMed: 27851994
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Peltonen</name><affiliation wicri:level="1"><nlm:affiliation>Teratology Information Service, Helsinki University and Helsinki University Hospital, Helsinki, Finland.</nlm:affiliation><country xml:lang="fr">Finlande</country><wicri:regionArea>Teratology Information Service, Helsinki University and Helsinki University Hospital, Helsinki</wicri:regionArea></affiliation></author><author><name sortKey="Kaplan, Y C" sort="Kaplan, Y C" uniqKey="Kaplan Y" first="Y C" last="Kaplan">Y C Kaplan</name><affiliation wicri:level="1"><nlm:affiliation>Terafar - Izmir Katip Celebi University Teratology Information, Training and Research Centre, Izmir, Turkey.</nlm:affiliation><country xml:lang="fr">Turquie</country><wicri:regionArea>Terafar - Izmir Katip Celebi University Teratology Information, Training and Research Centre, Izmir</wicri:regionArea></affiliation></author><author><name sortKey="Thomas, S H L" sort="Thomas, S H L" uniqKey="Thomas S" first="S H L" last="Thomas">S H L. 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Electronic address: jonathan.richardson@nuth.nhs.uk.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>The UK Teratology Information Service, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK; Institute of Cellular Medicine, Newcastle University, Newcastle upon Tyne</wicri:regionArea></affiliation></author><author><name sortKey="Stephens, S" sort="Stephens, S" uniqKey="Stephens S" first="S" last="Stephens">S. Stephens</name><affiliation wicri:level="1"><nlm:affiliation>The UK Teratology Information Service, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK; Institute of Cellular Medicine, Newcastle University, Newcastle upon Tyne, UK.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>The UK Teratology Information Service, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK; Institute of Cellular Medicine, Newcastle University, Newcastle upon Tyne</wicri:regionArea></affiliation></author><author><name sortKey="Yates, L M" sort="Yates, L M" uniqKey="Yates L" first="L M" last="Yates">L M Yates</name><affiliation wicri:level="1"><nlm:affiliation>The UK Teratology Information Service, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK; Institute of Genetic Medicine, Newcastle University, Newcastle upon Tyne, UK.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>The UK Teratology Information Service, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK; Institute of Genetic Medicine, Newcastle University, Newcastle upon Tyne</wicri:regionArea></affiliation></author><author><name sortKey="Diav Citrin, O" sort="Diav Citrin, O" uniqKey="Diav Citrin O" first="O" last="Diav-Citrin">O. Diav-Citrin</name><affiliation wicri:level="1"><nlm:affiliation>The Israeli Teratology Information Service, Jerusalem, Israel.</nlm:affiliation><country xml:lang="fr">Israël</country><wicri:regionArea>The Israeli Teratology Information Service, Jerusalem</wicri:regionArea></affiliation></author><author><name sortKey="Arnon, J" sort="Arnon, J" uniqKey="Arnon J" first="J" last="Arnon">J. Arnon</name><affiliation wicri:level="1"><nlm:affiliation>The Israeli Teratology Information Service, Jerusalem, Israel.</nlm:affiliation><country xml:lang="fr">Israël</country><wicri:regionArea>The Israeli Teratology Information Service, Jerusalem</wicri:regionArea></affiliation></author><author><name sortKey="Beghin, D" sort="Beghin, D" uniqKey="Beghin D" first="D" last="Beghin">D. Beghin</name><affiliation wicri:level="1"><nlm:affiliation>Centre de Référence sur les Agents Tératogènes (CRAT), Hôpitaux Universitaires Est Parisien (APHP), Paris, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Centre de Référence sur les Agents Tératogènes (CRAT), Hôpitaux Universitaires Est Parisien (APHP), Paris</wicri:regionArea></affiliation></author><author><name sortKey="Kayser, A" sort="Kayser, A" uniqKey="Kayser A" first="A" last="Kayser">A. Kayser</name><affiliation wicri:level="1"><nlm:affiliation>Pharmakovigilanz- und Beratungszentrum für Embryonaltoxikologie, Charité Universitätsmedizin, Berlin, Germany.</nlm:affiliation><country xml:lang="fr">Allemagne</country><wicri:regionArea>Pharmakovigilanz- und Beratungszentrum für Embryonaltoxikologie, Charité Universitätsmedizin, Berlin</wicri:regionArea></affiliation></author><author><name sortKey="Kennedy, D" sort="Kennedy, D" uniqKey="Kennedy D" first="D" last="Kennedy">D. Kennedy</name><affiliation wicri:level="1"><nlm:affiliation>Mothersafe at the Royal Hospital for Women, Sydney, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Mothersafe at the Royal Hospital for Women, Sydney</wicri:regionArea></affiliation></author><author><name sortKey="Cupitt, D" sort="Cupitt, D" uniqKey="Cupitt D" first="D" last="Cupitt">D. Cupitt</name><affiliation wicri:level="1"><nlm:affiliation>Mothersafe at the Royal Hospital for Women, Sydney, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Mothersafe at the Royal Hospital for Women, Sydney</wicri:regionArea></affiliation></author><author><name sortKey="Te Winkel, B" sort="Te Winkel, B" uniqKey="Te Winkel B" first="B" last="Te Winkel">B. Te Winkel</name><affiliation wicri:level="1"><nlm:affiliation>Teratology Information Service, Netherlands Pharmacovigilance Centre Lareb, 's-Hertogenbosch, The Netherlands.</nlm:affiliation><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Teratology Information Service, Netherlands Pharmacovigilance Centre Lareb, 's-Hertogenbosch</wicri:regionArea></affiliation></author><author><name sortKey="Peltonen, M" sort="Peltonen, M" uniqKey="Peltonen M" first="M" last="Peltonen">M. Peltonen</name><affiliation wicri:level="1"><nlm:affiliation>Teratology Information Service, Helsinki University and Helsinki University Hospital, Helsinki, Finland.</nlm:affiliation><country xml:lang="fr">Finlande</country><wicri:regionArea>Teratology Information Service, Helsinki University and Helsinki University Hospital, Helsinki</wicri:regionArea></affiliation></author><author><name sortKey="Kaplan, Y C" sort="Kaplan, Y C" uniqKey="Kaplan Y" first="Y C" last="Kaplan">Y C Kaplan</name><affiliation wicri:level="1"><nlm:affiliation>Terafar - Izmir Katip Celebi University Teratology Information, Training and Research Centre, Izmir, Turkey.</nlm:affiliation><country xml:lang="fr">Turquie</country><wicri:regionArea>Terafar - Izmir Katip Celebi University Teratology Information, Training and Research Centre, Izmir</wicri:regionArea></affiliation></author><author><name sortKey="Thomas, S H L" sort="Thomas, S H L" uniqKey="Thomas S" first="S H L" last="Thomas">S H L. Thomas</name><affiliation wicri:level="1"><nlm:affiliation>The UK Teratology Information Service, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK; Institute of Cellular Medicine, Newcastle University, Newcastle upon Tyne, UK.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>The UK Teratology Information Service, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK; Institute of Cellular Medicine, Newcastle University, Newcastle upon Tyne</wicri:regionArea></affiliation></author></analytic><series><title level="j">Reproductive toxicology (Elmsford, N.Y.)</title><idno type="eISSN">1873-1708</idno><imprint><date when="2017" type="published">2017</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Varenicline is a smoking cessation aid for which limited data exist concerning safety during human pregnancy. This multicentre prospective observational comparative cohort study was undertaken using surveillance data collected by the European Network of Teratology Information Services. The study sample consisted of 89 varenicline exposed pregnancies and two matched comparator groups; 267 non-teratogen exposed (NTE) controls and 78 exposed to nicotine replacement therapy or bupropion (NRT/B) for smoking cessation. For all exposed pregnancies, varenicline use only occurred in the first trimester, with a considerable proportion discontinuing use in the very early stages of pregnancy. The major congenital malformation rate (n=2/89, 2.25%) was in keeping with the expected background rate (2-4%), and was not significantly increased for first trimester varenicline-exposed infants in comparison with non-exposed controls (vs. NTE: OR 2.02, 95%CI 0.166 to 17.9, vs.</div></front></TEI><pubmed><MedlineCitation Status="In-Process" Owner="NLM"><PMID Version="1">27851994</PMID><DateCreated><Year>2016</Year><Month>11</Month><Day>16</Day></DateCreated><DateRevised><Year>2017</Year><Month>02</Month><Day>10</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1873-1708</ISSN><JournalIssue CitedMedium="Internet"><Volume>67</Volume><PubDate><Year>2017</Year><Month>Jan</Month></PubDate></JournalIssue><Title>Reproductive toxicology (Elmsford, N.Y.)</Title><ISOAbbreviation>Reprod. Toxicol.</ISOAbbreviation></Journal><ArticleTitle>Pregnancy outcomes after maternal varenicline use; analysis of surveillance data collected by the European Network of Teratology Information Services.</ArticleTitle><Pagination><MedlinePgn>26-34</MedlinePgn></Pagination><ELocationID EIdType="pii" ValidYN="Y">S0890-6238(16)30412-9</ELocationID><ELocationID EIdType="doi" ValidYN="Y">10.1016/j.reprotox.2016.11.010</ELocationID><Abstract><AbstractText>Varenicline is a smoking cessation aid for which limited data exist concerning safety during human pregnancy. This multicentre prospective observational comparative cohort study was undertaken using surveillance data collected by the European Network of Teratology Information Services. The study sample consisted of 89 varenicline exposed pregnancies and two matched comparator groups; 267 non-teratogen exposed (NTE) controls and 78 exposed to nicotine replacement therapy or bupropion (NRT/B) for smoking cessation. For all exposed pregnancies, varenicline use only occurred in the first trimester, with a considerable proportion discontinuing use in the very early stages of pregnancy. The major congenital malformation rate (n=2/89, 2.25%) was in keeping with the expected background rate (2-4%), and was not significantly increased for first trimester varenicline-exposed infants in comparison with non-exposed controls (vs. NTE: OR 2.02, 95%CI 0.166 to 17.9, vs.</AbstractText><AbstractText Label="NRT/B" NlmCategory="UNASSIGNED">OR 0.874, 95%CI 0.0620 to 12.3). However, the small sample size produced very imprecise risk estimates.</AbstractText><CopyrightInformation>Copyright © 2016 Elsevier Inc. All rights reserved.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Richardson</LastName><ForeName>J L</ForeName><Initials>JL</Initials><AffiliationInfo><Affiliation>The UK Teratology Information Service, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK; Institute of Cellular Medicine, Newcastle University, Newcastle upon Tyne, UK. Electronic address: jonathan.richardson@nuth.nhs.uk.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Stephens</LastName><ForeName>S</ForeName><Initials>S</Initials><AffiliationInfo><Affiliation>The UK Teratology Information Service, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK; Institute of Cellular Medicine, Newcastle University, Newcastle upon Tyne, UK.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Yates</LastName><ForeName>L M</ForeName><Initials>LM</Initials><AffiliationInfo><Affiliation>The UK Teratology Information Service, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK; Institute of Genetic Medicine, Newcastle University, Newcastle upon Tyne, UK.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Diav-Citrin</LastName><ForeName>O</ForeName><Initials>O</Initials><AffiliationInfo><Affiliation>The Israeli Teratology Information Service, Jerusalem, Israel.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Arnon</LastName><ForeName>J</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>The Israeli Teratology Information Service, Jerusalem, Israel.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Beghin</LastName><ForeName>D</ForeName><Initials>D</Initials><AffiliationInfo><Affiliation>Centre de Référence sur les Agents Tératogènes (CRAT), Hôpitaux Universitaires Est Parisien (APHP), Paris, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Kayser</LastName><ForeName>A</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>Pharmakovigilanz- und Beratungszentrum für Embryonaltoxikologie, Charité Universitätsmedizin, Berlin, Germany.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Kennedy</LastName><ForeName>D</ForeName><Initials>D</Initials><AffiliationInfo><Affiliation>Mothersafe at the Royal Hospital for Women, Sydney, Australia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Cupitt</LastName><ForeName>D</ForeName><Initials>D</Initials><AffiliationInfo><Affiliation>Mothersafe at the Royal Hospital for Women, Sydney, Australia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Te Winkel</LastName><ForeName>B</ForeName><Initials>B</Initials><AffiliationInfo><Affiliation>Teratology Information Service, Netherlands Pharmacovigilance Centre Lareb, 's-Hertogenbosch, The Netherlands.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Peltonen</LastName><ForeName>M</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>Teratology Information Service, Helsinki University and Helsinki University Hospital, Helsinki, Finland.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Kaplan</LastName><ForeName>Y C</ForeName><Initials>YC</Initials><AffiliationInfo><Affiliation>Terafar - Izmir Katip Celebi University Teratology Information, Training and Research Centre, Izmir, Turkey.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Thomas</LastName><ForeName>S H L</ForeName><Initials>SH</Initials><AffiliationInfo><Affiliation>The UK Teratology Information Service, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK; Institute of Cellular Medicine, Newcastle University, Newcastle upon Tyne, UK.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2016</Year><Month>11</Month><Day>13</Day></ArticleDate></Article><MedlineJournalInfo><Country>United States</Country><MedlineTA>Reprod Toxicol</MedlineTA><NlmUniqueID>8803591</NlmUniqueID><ISSNLinking>0890-6238</ISSNLinking></MedlineJournalInfo><KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="N">Birth defects</Keyword><Keyword MajorTopicYN="N">Congenital abnormalities</Keyword><Keyword MajorTopicYN="N">Elective termination</Keyword><Keyword MajorTopicYN="N">Intrauterine fetal death</Keyword><Keyword MajorTopicYN="N">Pregnancy</Keyword><Keyword MajorTopicYN="N">Smoking cessation</Keyword><Keyword MajorTopicYN="N">Spontaneous abortion</Keyword><Keyword MajorTopicYN="N">Varenicline</Keyword></KeywordList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="received"><Year>2016</Year><Month>07</Month><Day>15</Day></PubMedPubDate><PubMedPubDate PubStatus="revised"><Year>2016</Year><Month>11</Month><Day>03</Day></PubMedPubDate><PubMedPubDate PubStatus="accepted"><Year>2016</Year><Month>11</Month><Day>11</Day></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2016</Year><Month>11</Month><Day>17</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2016</Year><Month>11</Month><Day>17</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2016</Year><Month>11</Month><Day>17</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">27851994</ArticleId><ArticleId IdType="pii">S0890-6238(16)30412-9</ArticleId><ArticleId IdType="doi">10.1016/j.reprotox.2016.11.010</ArticleId></ArticleIdList></PubmedData></pubmed></record>Pour manipuler ce document sous Unix (Dilib)
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