Pregnancy outcome of women exposed to bupropion during pregnancy: a prospective comparative study.
OBJECTIVE
Bupropion was developed for the treatment of depression, but subsequently was found to be effective for smoking cessation. To date, there are no prospective comparative studies examining its safety in pregnancy. The primary objective was to determine whether bupropion increases the risks for major malformations above baseline. The secondary objective was to examine the rates of live births, stillbirths, spontaneous and therapeutic abortions, mean birth weight, and gestational age at birth.


METHODS
Women who were pregnant or planning a pregnancy and taking bupropion were enrolled in the study. Follow-up of pregnancy outcome was carried out between 4 months and 1 year after delivery. Three comparisons were carried out: 1) women exposed to bupropion vs a nonteratogen group; 2) those taking for depression vs other antidepressants, vs a nonteratogen group; 3) spontaneous abortions were compared between those taking for depression, vs another antidepressant group vs a nonteratogen group.


RESULTS
We completed follow-up on 136 women exposed to bupropion during the first trimester of pregnancy. There were (105) live births, no major malformations, the mean birth weight was (3450g), the mean gestational age at delivery was (40 weeks), the number of spontaneous abortions was 20, there were 10 therapeutic abortions, there was 1 stillbirth, and 1 neonatal death. There were no statistically significant differences between any of the end points we examined between the exposed and comparison groups, with the exception of significantly more spontaneous abortions in the bupropion group (P = .009).


CONCLUSIONS
These results suggest that bupropion does not increase the rates of major malformation above baseline. The higher rates of spontaneous abortions are similar to other studies examining the safety of antidepressants during pregnancy.
Chun-Fai-Chan
Brian
B
The Motherisk Program, The Hospital for Sick Children, Toronto, Ontario, Canada.
Koren
Gideon
G
Fayez
Ibrahim
I
Kalra
Sanjog
S
Voyer-Lavigne
Sharon
S
Boshier
Andrew
A
Shakir
Saad
S
Einarson
Adrienne
A
D000014:Abnormalities, Drug-Induced / Q000209:etiology*; D000022:Abortion, Spontaneous / Q000139:chemically induced; D018687:Antidepressive Agents, Second-Generation / Q000009:adverse effects*; D001724:Birth Weight / Q000187:drug effects; D016642:Bupropion / Q000009:adverse effects*; D005260:Female; D005313:Fetal Death / Q000139:chemically induced; D006801:Humans; D011247:Pregnancy; D011256:Pregnancy Outcome; D011446:Prospective Studies; D016540:Smoking Cessation / Q000379:methods
D018687:Antidepressive Agents, Second-Generation; D016642:Bupropion