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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. METHOD: From teratology information services around the world, the authors collected prospectively ascertained, unpublished cases of infants exposed to paroxetine early in the first trimester of pregnancy and compared them with an unexposed cohort.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%.

This article has been cited by other articles:

				B. L. Parry Assessing Risk and Benefit: To Treat or Not to Treat Major Depression During Pregnancy With Antidepressant Medication Am J Psychiatry, May 1, 2009; 166(5): 512 - 514. [Full Text] [PDF]

				C. L. Wichman, K. M. Moore, T. R. Lang, J. L. St. Sauver, R. H. Heise Jr, and W. J. Watson Congenital Heart Disease Associated With Selective Serotonin Reuptake Inhibitor Use During Pregnancy Mayo Clin. Proc., January 1, 2009; 84(1): 23 - 27. [Abstract] [Full Text] [PDF]

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