Does paroxetine cause cardiac malformations?
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.
O'Brien
Lisa
L
The Motherisk Program, The Hospital for Sick Children, Toronto, Toronto ON; Institute of Medical Science, University of Toronto, Toronto ON.
Einarson
Thomas R
TR
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.
Sarkar
Moumita
M
The Motherisk Program, The Hospital for Sick Children, Toronto, Toronto ON; Institute of Medical Science, University of Toronto, Toronto ON.
Einarson
Adrienne
A
The Motherisk Program, The Hospital for Sick Children, Toronto, Toronto ON.
Koren
Gideon
G
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.
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*
D017374:Paroxetine; D017367:Selective Serotonin Reuptake Inhibitors