This paper has potential financial conflicts of interest.
Bupropion in pregnancy and the prevalence of congenital malformations†
Version of Record online: 9 AUG 2006
Copyright © 2006 John Wiley & Sons, Ltd.
Pharmacoepidemiology and Drug Safety
Volume 16, Issue 5, pages 474–484, May 2007
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
- Issue online: 1 MAY 2007
- Version of Record online: 9 AUG 2006
- Manuscript Accepted: 21 JUN 2006
- Manuscript Revised: 9 JUN 2006
- Manuscript Received: 22 MAR 2006
- first trimester;
- congenital malformations;
- cardiovascular malformations;
- odds ratio;
- insurance claims
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.
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.
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.
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.