title: Pregnancy outcomes after maternal varenicline use; analysis of surveillance data collected by the European Network of Teratology Information Services.
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.
  
  
  
  OR 0.874, 95%CI 0.0620 to 12.3). However, the small sample size produced very imprecise risk estimates.
authors.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.
authors.forename: J L
authors.initials: JL
authors.lastname: Richardson
authors.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.
authors.forename: S
authors.initials: S
authors.lastname: Stephens
authors.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.
authors.forename: L M
authors.initials: LM
authors.lastname: Yates
authors.affiliation: The Israeli Teratology Information Service, Jerusalem, Israel.
authors.forename: O
authors.initials: O
authors.lastname: Diav-Citrin
authors.affiliation: The Israeli Teratology Information Service, Jerusalem, Israel.
authors.forename: J
authors.initials: J
authors.lastname: Arnon
authors.affiliation: Centre de Référence sur les Agents Tératogènes (CRAT), Hôpitaux Universitaires Est Parisien (APHP), Paris, France.
authors.forename: D
authors.initials: D
authors.lastname: Beghin
authors.affiliation: Pharmakovigilanz- und Beratungszentrum für Embryonaltoxikologie, Charité Universitätsmedizin, Berlin, Germany.
authors.forename: A
authors.initials: A
authors.lastname: Kayser
authors.affiliation: Mothersafe at the Royal Hospital for Women, Sydney, Australia.
authors.forename: D
authors.initials: D
authors.lastname: Kennedy
authors.affiliation: Mothersafe at the Royal Hospital for Women, Sydney, Australia.
authors.forename: D
authors.initials: D
authors.lastname: Cupitt
authors.affiliation: Teratology Information Service, Netherlands Pharmacovigilance Centre Lareb, 's-Hertogenbosch, The Netherlands.
authors.forename: B
authors.initials: B
authors.lastname: Te Winkel
authors.affiliation: Teratology Information Service, Helsinki University and Helsinki University Hospital, Helsinki, Finland.
authors.forename: M
authors.initials: M
authors.lastname: Peltonen
authors.affiliation: Terafar - Izmir Katip Celebi University Teratology Information, Training and Research Centre, Izmir, Turkey.
authors.forename: Y C
authors.initials: YC
authors.lastname: Kaplan
authors.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.
authors.forename: S H L
authors.initials: SH
authors.lastname: Thomas
mesh_terms: D000013:Congenital Abnormalities / Q000453:epidemiology* / Q000209:etiology; D062665:Epidemiological Monitoring; D005060:Europe; D005260:Female; D006801:Humans; D018811:Maternal Exposure / Q000009:adverse effects*; D018722:Nicotinic Agonists / Q000633:toxicity*; D011247:Pregnancy; D011256:Pregnancy Outcome / Q000453:epidemiology*; D011261:Pregnancy Trimester, First; D011446:Prospective Studies; D061485:Tobacco Use Cessation Devices / Q000009:adverse effects*; D000068580:Varenicline / Q000633:toxicity*
chemical_list: D018722:Nicotinic Agonists; D000068580:Varenicline
keywords: Birth defects; Congenital abnormalities; Elective termination; Intrauterine fetal death; Pregnancy; Smoking cessation; Spontaneous abortion; Varenicline