Evaluation of the risk of congenital cardiovascular defects associated with use of paroxetine during pregnancy.
OBJECTIVE
In 2005-2006, several studies noted an increased risk of cardiovascular birth defects associated with maternal use of paroxetine compared with other antidepressants in the same class. In this study, the authors sought to determine whether paroxetine was associated with an increased risk of cardiovascular defects in infants of women exposed to the drug during the first trimester of pregnancy.


METHODS
From teratology information services around the world, the authors collected prospectively ascertained, unpublished cases of infants exposed to paroxetine early in the first trimester of pregnancy and compared them with an unexposed cohort. The authors also contacted the authors of published database studies on antidepressants as a class to determine how many of the women in those studies had been exposed to paroxetine and the rates of cardiovascular defects in their infants.


RESULTS
The authors were able to ascertain the outcomes of 1,174 infants from eight services. The rates of cardiac defects in the paroxetine group and in the unexposed group were both 0.7%. The rate in the database studies (2,061 cases from four studies) was 1.5%.


CONCLUSIONS
Paroxetine does not appear to be associated with an increased risk of cardiovascular defects following use in early pregnancy, as the incidence in more than 3,000 infants was well within the population incidence of approximately 1%.
Einarson
Adrienne
A
Motherisk Program, Hospital for Sick Children, Division of Clinical Pharmacology, University of Toronto, 555 University Ave., Toronto, Ontario M5G 1X8, Canada. einarson@sickkids.ca
Pistelli
Alessandra
A
DeSantis
Marco
M
Malm
Heli
H
Paulus
Wolfgang D
WD
Panchaud
Alice
A
Kennedy
Debra
D
Einarson
Thomas R
TR
Koren
Gideon
G
D000014:Abnormalities, Drug-Induced / Q000453:epidemiology*; D018687:Antidepressive Agents, Second-Generation / Q000627:therapeutic use / Q000633:toxicity*; D003865:Major Depressive Disorder / Q000188:drug therapy* / Q000453:epidemiology; D005260:Female; D006330:Heart Defects, Congenital / Q000139:chemically induced*; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D016017:Odds Ratio; D017374:Paroxetine / Q000627:therapeutic use / Q000633:toxicity*; D011247:Pregnancy; D011248:Pregnancy Complications / Q000188:drug therapy* / Q000453:epidemiology; D011261:Pregnancy Trimester, First; D018570:Risk Assessment
D018687:Antidepressive Agents, Second-Generation; D017374:Paroxetine