title: Does paroxetine cause cardiac malformations?
abstract: BACKGROUND
  Debate has recently arisen about the safety of paroxetine use in pregnancy, prompted by reports of increased risks for cardiac defects following first trimester exposure.
  
  
  METHODS
  We conducted a meta-analysis of nine studies.
  
  
  RESULTS
  Three case-control studies (N = 30,247) found no increased risk of congenital malformations associated with paroxetine (OR = 1.18; 95% CI 0.88-1.59). Cardiac malformation rates were similar (1.1% each) and within population norms (0.7-1.2%). Six cohort studies (N = 66,409) found a non-significant weighted average difference of 0.3% (95% CI -0.1-0.7%; P = 0.19).
  
  
  CONCLUSIONS
  First-trimester exposure to paroxetine does not appear to be associated with increased rates of cardiac malformations. This information should be reassuring to prescribing physicians and women who require treatment with paroxetine in pregnancy.
authors.affiliation: The Motherisk Program, The Hospital for Sick Children, Toronto, Toronto ON; Institute of Medical Science, University of Toronto, Toronto ON.
authors.forename: Lisa
authors.initials: L
authors.lastname: O'Brien
authors.affiliation: The Motherisk Program, The Hospital for Sick Children, Toronto, Toronto ON; Department of Pediatrics, The Hospital for Sick Children, Toronto, Toronto ON; Leslie Dan Faculty of Pharmacy, University of Toronto, Toronto ON.
authors.forename: Thomas R
authors.initials: TR
authors.lastname: Einarson
authors.affiliation: The Motherisk Program, The Hospital for Sick Children, Toronto, Toronto ON; Institute of Medical Science, University of Toronto, Toronto ON.
authors.forename: Moumita
authors.initials: M
authors.lastname: Sarkar
authors.affiliation: The Motherisk Program, The Hospital for Sick Children, Toronto, Toronto ON.
authors.forename: Adrienne
authors.initials: A
authors.lastname: Einarson
authors.affiliation: The Motherisk Program, The Hospital for Sick Children, Toronto, Toronto ON; Institute of Medical Science, University of Toronto, Toronto ON; Department of Pediatrics, The Hospital for Sick Children, Toronto, Toronto ON.
authors.forename: Gideon
authors.initials: G
authors.lastname: Koren
mesh_terms: D016022:Case-Control Studies; D015331:Cohort Studies; D064420:Drug-Related Side Effects and Adverse Reactions; D005260:Female; D006330:Heart Defects, Congenital / Q000139:chemically induced* / Q000453:epidemiology; D006801:Humans; D017374:Paroxetine / Q000009:adverse effects*; D011247:Pregnancy; D011261:Pregnancy Trimester, First; D017367:Selective Serotonin Reuptake Inhibitors / Q000009:adverse effects*
chemical_list: D017374:Paroxetine; D017367:Selective Serotonin Reuptake Inhibitors