Wellbutrin XL Use In Pregnancy & Lactation

Pregnancy: Teratogenic Effects: Pregnancy Category C: In studies conducted in rats and rabbits, bupropion was administered orally at doses up to 450 and 150 mg/kg/day, respectively (approximately 11 and 7 times the MRHD, respectively, on a mg/m² basis), during the period of organogenesis. No clear evidence of teratogenic activity was found in either species; however, in rabbits, slightly increased incidences of fetal malformations and skeletal variations were observed at the lowest dose tested (25 mg/kg/day, approximately equal to the MRHD on a mg/m² basis) and greater. Decreased fetal weights were seen at ≥50 mg/kg.
When rats were administered bupropion at oral doses of up to 300 mg/kg/day (approximately 7 times the MRHD on a mg/m² basis) prior to mating and throughout pregnancy and lactation, there were no apparent adverse effects on offspring development.
One (1) study has been conducted in pregnant women. This retrospective, managed-care database study assessed the risk of congenital malformations overall, and cardiovascular malformations specifically, following exposure to bupropion in the 1st trimester compared to the risk of these malformations following exposure to other antidepressants in the 1st trimester and bupropion outside of the 1st trimester. This study included 7,005 infants with antidepressant exposure during pregnancy, 1,213 of whom were exposed to bupropion in the 1st trimester. The study showed no greater risk for congenital malformations overall, or cardiovascular malformations specifically, following 1st trimester bupropion exposure compared to exposure to all other antidepressants in the 1st trimester or bupropion outside of the 1st trimester. The results of this study have not been corroborated. Wellbutrin XL should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
In a retrospective, case-control analysis using data from the National Birth Defects Prevention Study, there were 12,383 case infants and 5,869 control infants. A statistically significant association was observed between the occurrence of a left outflow tract heart defect in the infant and self-reported maternal bupropion use in early pregnancy (n=10; adjusted OR=2.6; 95% CI 1.2, 5.7). No association was observed between maternal bupropion use and any other type of cardiac defect or with all categories of heart defects combined.
A further case-control analysis of data from the Slone Epidemiology Center Birth Defects Study included 7,913 infant cases of cardiac defects and 8,611 controls. This found no statistically significant increase of left outflow tract heart defects with maternal bupropion use (n=2; adjusted OR=0.4; 95% CI 0.1, 1.6). However, a statistically significant association was observed for ventricular septal defects (n=17; adjusted OR=2.5; 95% CI 1.3, 5) following the use of bupropion alone during the 1st trimester.
Labor and Delivery: The effect of Wellbutrin XL on labor and delivery in humans is unknown.
Lactation: Like many other drugs, bupropion and its metabolites are secreted in human milk. Because of the potential for serious adverse reactions in nursing infants from Wellbutrin XL, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.