title: Bupropion in pregnancy and the prevalence of congenital malformations.
abstract: OBJECTIVE
  Reports from the GlaxoSmithKline Bupropion Pregnancy Registry suggested an increase in cardiovascular defects following exposure to bupropion during pregnancy. We conducted a study of congenital malformations among infants born to women exposed to bupropion during their first trimester.
  
  
  METHODS
  The study used data from UnitedHealthcare between January 1995 and September 2004. We calculated the prevalence of all congenital malformations and cardiovascular malformations associated with bupropion exposure in the estimated first trimester (1213 infants), compared with (1) other antidepressant exposure in the first trimester (4743 infants) and (2) bupropion exposure outside the first trimester (1049 infants). Malformation cases were confirmed through medical record abstraction. We calculated adjusted odds ratios (AORs) using the GEE form of logistic regression.
  
  
  RESULTS
  For all congenital malformations, the prevalence associated with bupropion first trimester was 23.1 per 1000 infants. The AORs were 0.95 (95%CI 0.62-1.45) and 1.00 (95%CI 0.57-1.73) in comparison to other antidepressants (prevalence 23.2 per 1000) and bupropion outside the first trimester (prevalence 21.9 per 1000), respectively. For cardiovascular malformations, the prevalence associated with bupropion first trimester was 10.7 per 1000 infants. The AORs were 0.97 (95%CI 0.52-1.80) and 1.07 (95%CI 0.48-2.40) in comparison to other antidepressants (prevalence 10.8 per 1000) and bupropion outside the first trimester (prevalence 9.5 per 1000), respectively.
  
  
  CONCLUSIONS
  Results do not support a hypothesis of a teratogenic effect of first trimester bupropion exposure. The prevalence of malformations associated with bupropion exposure in the first trimester was not increased relative to the comparison groups.
authors.affiliation: i3 Drug Safety, Epidemiology, Auburndale, MA 02466, USA. alex.cole@i3drugsafety.com
authors.forename: J Alexander
authors.initials: JA
authors.lastname: Cole
authors.forename: Jack G
authors.initials: JG
authors.lastname: Modell
authors.forename: Barbara R
authors.initials: BR
authors.lastname: Haight
authors.forename: Irene S
authors.initials: IS
authors.lastname: Cosmatos
authors.forename: Joan M
authors.initials: JM
authors.lastname: Stoler
authors.forename: Alexander M
authors.initials: AM
authors.lastname: Walker
mesh_terms: D000293:Adolescent; D000328:Adult; D018687:Antidepressive Agents, Second-Generation / Q000009:adverse effects / Q000627:therapeutic use; D016642:Bupropion / Q000009:adverse effects* / Q000627:therapeutic use; D000013:Congenital Abnormalities / Q000453:epidemiology* / Q000209:etiology; D016208:Databases, Factual / Q000706:statistics & numerical data; D005260:Female; D006330:Heart Defects, Congenital / Q000453:epidemiology* / Q000209:etiology; D006801:Humans; D007223:Infant; D008297:Male; D008423:Maternal Age; D008875:Middle Aged; D016017:Odds Ratio; D011247:Pregnancy; D011261:Pregnancy Trimester, First; D015995:Prevalence; D012042:Registries / Q000706:statistics & numerical data; D012189:Retrospective Studies; D013997:Time Factors; D014481:United States / Q000453:epidemiology
chemical_list: D018687:Antidepressive Agents, Second-Generation; D016642:Bupropion