Bupropion Pregnancy and Breastfeeding Warnings
Bupropion Pregnancy Warnings
Bupropion has been assigned to pregnancy category C by the FDA. High dose animal studies have failed to reveal evidence of specific teratogenic effects. Low dose animal studies in rabbits have reported a slightly increased incidence of fetal malformations and skeletal variations. A retrospective database of infants (n=7005) whose mothers were exposed to bupropion in the first trimester and outside of the first trimester failed to reveal an increased risk for congenital malformation, especially cardiovascular malformation. Bupropion is only recommended for use during pregnancy when benefit outweighs risk.
Bupropion Breastfeeding Warnings
One case report has suggested that bupropion accumulates in human breast milk in concentrations much greater than in maternal plasma. At least two metabolites of bupropion are also detectable in human milk. However, in the plasma of one nursing infant whose mother took bupropion, neither bupropion nor its metabolites could be detected. Data from four mother-infant pairs showed mean breast milk concentrations were 64.1 ng/mL at peak and 9.2 ng/mL at trough. Bupropion was detected in one of the four infant urine samples. The average milk-serum ratio was 1.3. The average infant dose was 5.7% of the weight adjusted maternal dose.
Bupropion is excreted into human milk. The effects in the nursing infant are unknown. The manufacturer suggests that a decision to discontinue breast-feeding or discontinue bupropion therapy should be made based on the importance of the drug to the mother.
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