Original Report

Bupropion in pregnancy and the prevalence of congenital malformations†

  1. J. Alexander Cole D.Sc., MPH1,*,
  2. Jack G. Modell M.D.2,
  3. Barbara R. Haight Pharm D2,
  4. Irene S. Cosmatos M.S.3,
  5. Joan M. Stoler M.D.4,
  6. Alexander M. Walker M.D., Dr, P.H.1

Article first published online: 9 AUG 2006

DOI: 10.1002/pds.1296

Issue

Pharmacoepidemiology and Drug Safety

Pharmacoepidemiology and Drug Safety

Volume 16, Issue 5, pages 474–484, May 2007

Additional Information

How to Cite

Cole, J. A., Modell, J. G., Haight, B. R., Cosmatos, I. S., Stoler, J. M. and Walker, A. M. (2007), Bupropion in pregnancy and the prevalence of congenital malformations. Pharmacoepidem. Drug Safe., 16: 474–484. doi: 10.1002/pds.1296

Author Information

  1. 1

    i3 Drug Safety, Epidemiology, Auburndale, MA, USA

  2. 2

    GlaxoSmithKline, Neurosciences Medicine Development Center, Research Triangle Park, NC, USA

  3. 3

    GlaxoSmithKline, Worldwide Epidemiology, Philadelphia, PA, USA

  4. 4

    Massachusetts General Hospital, Genetics and Teratology Unit, Department of Pediatrics, Boston, MA, USA

*i3 Drug Safety, Riverside Center, Suite 3-120, 275 Grove Street, Auburndale, MA 02466.

  1. †

    This paper has potential financial conflicts of interest.

Publication History

  1. Issue published online: 1 MAY 2007
  2. Article first published online: 9 AUG 2006
  3. Manuscript Accepted: 21 JUN 2006
  4. Manuscript Revised: 9 JUN 2006
  5. Manuscript Received: 22 MAR 2006

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Keywords:

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

Abstract

Purpose

Reports from the GlaxoSmithKline Bupropion Pregnancy Registry suggested an increase in cardiovascular defects following exposure to bupropion during pregnancy. We conducted a study of congenital malformations among infants born to women exposed to bupropion during their first trimester.

Methods

The study used data from UnitedHealthcare between January 1995 and September 2004. We calculated the prevalence of all congenital malformations and cardiovascular malformations associated with bupropion exposure in the estimated first trimester (1213 infants), compared with (1) other antidepressant exposure in the first trimester (4743 infants) and (2) bupropion exposure outside the first trimester (1049 infants). Malformation cases were confirmed through medical record abstraction. We calculated adjusted odds ratios (AORs) using the GEE form of logistic regression.

Results

For all congenital malformations, the prevalence associated with bupropion first trimester was 23.1 per 1000 infants. The AORs were 0.95 (95%CI 0.62–1.45) and 1.00 (95%CI 0.57–1.73) in comparison to other antidepressants (prevalence 23.2 per 1000) and bupropion outside the first trimester (prevalence 21.9 per 1000), respectively. For cardiovascular malformations, the prevalence associated with bupropion first trimester was 10.7 per 1000 infants. The AORs were 0.97 (95%CI 0.52–1.80) and 1.07 (95%CI 0.48–2.40) in comparison to other antidepressants (prevalence 10.8 per 1000) and bupropion outside the first trimester (prevalence 9.5 per 1000), respectively.

Conclusions

Results do not support a hypothesis of a teratogenic effect of first trimester bupropion exposure. The prevalence of malformations associated with bupropion exposure in the first trimester was not increased relative to the comparison groups. Copyright © 2006 John Wiley & Sons, Ltd.

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