Counseling pregnant women treated with paroxetine. Concern about cardiac malformations

I have always reassured my patients that taking selective serotonin reuptake inhibitors (SSRIs) during pregnancy would not increase their risk of having children with major malformations. A recent warning from Health Canada, based on results of a study from GlaxoSmithKline, stated that infants exposed to paroxetine might be at higher risk of congenital malformations, specifically cardiovascular defects. Some of my pregnant patients who are taking paroxetine heard the warning and asked me whether they should stop taking it. What should I tell them?

The new warning is based on unpublished, non-peer-reviewed studies. It ignored 2 published studies that failed to show any association between exposure to paroxetine and cardiovascular malformations, and no association with cardiovascular malformations has been shown by SSRIs as a class. Even if there is risk, it is minimal, and the warning does not disclose details of the cardiovascular malformations. Many cases of ventricular septal defect, the most common cardiac malformation, resolve spontaneously. Concerned pregnant women should know that, if taken after the first trimester, drugs cannot cause cardiac malformations. Failure to treat depression during pregnancy can have severe consequences for both mothers and babies and is the strongest predictor of postpartum depression.