Paroxetine use during pregnancy: is it safe?

OBJECTIVE: To evaluate the literature assessing the neonatal risks of antepartum paroxetine use.

DATA SOURCES: MEDLINE (1966-August 2006) and International Pharmaceutical Abstracts (1970-August 2006) searches were performed. Key search terms included paroxetine, SSRI, pregnancy, malformations, neonate, and fetus.

DATA SYNTHESIS: Selective serotonin-reuptake inhibitors (SSRIs) are associated with neonatal withdrawal symptoms such as respiratory distress, irritability, lethargy, and tremors. In a cohort study, 30% of infants exposed to SSRIs had poor neonatal adaptation, compared with 9% of controls (p = 0.018). Some reports indicate that paroxetine is more commonly associated with neonatal withdrawal than other SSRIs. Recently, paroxetine was associated with a 1.82-fold (95% CI 1.17 to 2.82) increased risk of congenital malformations compared with other antidepressants. Other SSRIs were also associated with an increased risk of congenital malformations; however, the results were not statistically significant. Literature supporting these findings includes case reports and case-control or cohort studies. The Food and Drug Administration recommendations regarding paroxetine use during pregnancy have been added to the labeling information.

CONCLUSIONS: Paroxetine may cause adverse outcomes in the neonate when used during pregnancy and should be discontinued in women who are pregnant or trying to become pregnant. The risks and benefits of other antidepressant use should be analyzed on an individual basis.