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Bupropion in pregnancy and the prevalence of congenital malformations.
Pharmacoepidemiol Drug Saf. 2007 May; 16(5):474-84.PD

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.

Authors+Show Affiliations

i3 Drug Safety, Epidemiology, Auburndale, MA 02466, USA. alex.cole@i3drugsafety.comNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article

Language

eng

PubMed ID

16897811

Citation

Cole, J Alexander, et al. "Bupropion in Pregnancy and the Prevalence of Congenital Malformations." Pharmacoepidemiology and Drug Safety, vol. 16, no. 5, 2007, pp. 474-84.
Cole JA, Modell JG, Haight BR, et al. Bupropion in pregnancy and the prevalence of congenital malformations. Pharmacoepidemiol Drug Saf. 2007;16(5):474-84.
Cole, J. A., Modell, J. G., Haight, B. R., Cosmatos, I. S., Stoler, J. M., & Walker, A. M. (2007). Bupropion in pregnancy and the prevalence of congenital malformations. Pharmacoepidemiology and Drug Safety, 16(5), 474-84.
Cole JA, et al. Bupropion in Pregnancy and the Prevalence of Congenital Malformations. Pharmacoepidemiol Drug Saf. 2007;16(5):474-84. PubMed PMID: 16897811.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Bupropion in pregnancy and the prevalence of congenital malformations. AU - Cole,J Alexander, AU - Modell,Jack G, AU - Haight,Barbara R, AU - Cosmatos,Irene S, AU - Stoler,Joan M, AU - Walker,Alexander M, PY - 2006/8/10/pubmed PY - 2007/9/12/medline PY - 2006/8/10/entrez SP - 474 EP - 84 JF - Pharmacoepidemiology and drug safety JO - Pharmacoepidemiol Drug Saf VL - 16 IS - 5 N2 - 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. SN - 1053-8569 UR - https://www.unboundmedicine.com/medline/citation/16897811/Bupropion_in_pregnancy_and_the_prevalence_of_congenital_malformations_ L2 - https://doi.org/10.1002/pds.1296 DB - PRIME DP - Unbound Medicine ER -