Original Report

Paroxetine in the first trimester and the prevalence of congenital malformations†

  1. J. Alexander Cole DSc, MPH1,‡,*,
  2. Sara A. Ephross PhD2,
  3. Irene S. Cosmatos MS3,
  4. Alexander M. Walker MD, DrPH1

Article first published online: 30 AUG 2007

DOI: 10.1002/pds.1463

Issue

Pharmacoepidemiology and Drug Safety

Pharmacoepidemiology and Drug Safety

Volume 16, Issue 10, pages 1075–1085, October 2007

Additional Information

How to Cite

Cole, J. A., Ephross, S. A., Cosmatos, I. S. and Walker, A. M. (2007), Paroxetine in the first trimester and the prevalence of congenital malformations. Pharmacoepidem. Drug Safe., 16: 1075–1085. doi: 10.1002/pds.1463

Author Information

  1. 1

    i3 Drug Safety, Auburndale, MA, USA

  2. 2

    GlaxoSmithKline, Research Triangle Park, NC, USA

  3. 3

    GlaxoSmithKline, Philadelphia, PA, USA

  1. ‡

    Genzyme Corporation, Cambridge, MA, USA.

*500 Kendall Street, Cambridge, MA 02142, USA.

  1. †

    The sponsor of this project, who had provided funding as it was one of their products being studied, had the right of commenting but the author had the right to accept or reject their comments.

Publication History

  1. Issue published online: 29 SEP 2007
  2. Article first published online: 30 AUG 2007
  3. Manuscript Accepted: 9 JUL 2007
  4. Manuscript Revised: 27 FEB 2007
  5. Manuscript Received: 15 AUG 2006

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Keywords:

  • paroxetine;
  • antidepressants;
  • pregnancy;
  • first trimester;
  • teratogen;
  • congenital malformations;
  • cardiovascular malformations;
  • prevalence;
  • odds ratio;
  • insurance claims

Abstract

Purpose

To refine a preliminary analysis identifying a possibly increased prevalence of malformations among infants born to women exposed to paroxetine in the first trimester.

Methods

This study used data from UnitedHealthcare, a large U.S. insurer, using datasets originally for a study of bupropion in pregnancy. We identified women with a live-born delivery between January 1995 and September 2004. We classified women according to their first trimester mono- or mono/polytherapy exposure to paroxetine and other antidepressants. We confirmed malformation cases by medical record abstraction. We calculated the adjusted odds ratios (AORs) through logistic regression.

Results

For paroxetine, there were 815 infants among 791 women exposed as monotherapy, and 1020 infants among 989 women exposed as mono- or polytherapy. For other antidepressants, there were 4198 infants among 4072 women exposed as monotherapy, and 4936 infants among 4767 women exposed as mono- or polytherapy. AORs for all congenital malformations associated with paroxetine were 1.89 (95%CI 1.20–2.98) for monotherapy, and 1.76 (95%CI 1.18–2.64) for mono- or polytherapy. AORs for cardiovascular malformations associated with paroxetine were 1.46 (95%CI 0.74–2.88) for monotherapy, and 1.68 (95%CI 0.95–2.97) for mono- or polytherapy.

Conclusions

These more detailed paroxetine findings confirm previous findings of analyses of these data among women exposed to all types of antidepressants. The present findings are consistent with other recent results suggesting the possibility of a modestly increased occurrence of congenital malformations following first trimester exposure to paroxetine compared to other antidepressants. Copyright © 2007 John Wiley & Sons, Ltd.

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