Pregnant women
Early results of new studies show that paroxetine increases the risk of birth defects, particularly heart defects, when women take it during the first three months of pregnancy. Paroxetine should usually not be taken during pregnancy, but for some women who have already been taking paroxetine, the benefits of continuing paroxetine may be greater than the potential risk to the baby. Women taking paroxetine who are pregnant, think they may be pregnant, or plan to become pregnant should talk to their physicians about the potential risks of taking paroxetine during pregnancy.

The early results of two studies showed that women who took paroxetine (Paxil) during the first three months of pregnancy were about one and a half to two times as likely to have a baby with a heart defect as women who received other antidepressants, and women in the general population. Most of the heart defects in these studies were not life-threatening, and happened mainly in the inside walls of the heart muscle where repairs can be done if needed (atrial and ventricular septal defects). Sometimes these septal defects resolve without treatment. In one of the studies, the risk of heart defects in babies whose mothers had taken paroxetine early in pregnancy was 2%, compared to a 1% risk in the whole population. In the other study, the risk of heart defects in babies whose mothers had taken paroxetine in the first three months of pregnancy was 1.5%, compared to 1% in babies whose mothers had taken other antidepressants in the first three months of pregnancy. This study also showed that women who took paroxetine in the first three months of pregnancy were about twice as likely to have a baby with any birth defect as women who took other antidepressants.

The FDA is currently in the process of gathering additional data to better understand these observations.

This information reflects FDA’s current analysis of data available to FDA concerning this drug. FDA intends to update this sheet when additional information or analyses become available.

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