Bupropion in pregnancy and the prevalence of congenital malformations.
OBJECTIVE
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.
Cole
J Alexander
JA
i3 Drug Safety, Epidemiology, Auburndale, MA 02466, USA. alex.cole@i3drugsafety.com
Modell
Jack G
JG
Haight
Barbara R
BR
Cosmatos
Irene S
IS
Stoler
Joan M
JM
Walker
Alexander M
AM
D000293:Adolescent; D000328:Adult; D018687:Antidepressive Agents, Second-Generation / Q000009:adverse effects / Q000627:therapeutic use; D016642:Bupropion / Q000009:adverse effects* / Q000627:therapeutic use; D000013:Congenital Abnormalities / Q000453:epidemiology* / Q000209:etiology; D016208:Databases, Factual / Q000706:statistics & numerical data; D005260:Female; D006330:Heart Defects, Congenital / Q000453:epidemiology* / Q000209:etiology; D006801:Humans; D007223:Infant; D008297:Male; D008423:Maternal Age; D008875:Middle Aged; D016017:Odds Ratio; D011247:Pregnancy; D011261:Pregnancy Trimester, First; D015995:Prevalence; D012042:Registries / Q000706:statistics & numerical data; D012189:Retrospective Studies; D013997:Time Factors; D014481:United States / Q000453:epidemiology
D018687:Antidepressive Agents, Second-Generation; D016642:Bupropion