First-Trimester Antidepressant Use and Cardiac Defects

June 18, 2014

First-Trimester Antidepressant Use and Cardiac Defects

  1. Deborah Cowley, MD

No increased risk was found in an analysis of Medicaid data.

  1. Deborah Cowley, MD

Published studies have raised concerns that first-trimester use of antidepressants might increase risk for cardiac defects, especially right ventricular outflow tract obstruction with paroxetine and ventricular septal defects with sertraline. These authors used a large national database to examine rates of cardiac malformations with first-trimester antidepressant exposure.

Subjects were 949,504 women (aged 12–55) and their liveborn infants. The women had been enrolled in Medicaid between 3 months before the last menstrual period and 1 month after delivery. During the first trimester, 64,389 women (6.8%) used an antidepressant, more than two thirds of whom used selective serotonin reuptake inhibitors. Cardiac malformations were diagnosed in 90 per 10,000 antidepressant-exposed infants versus 72 per 10,000 unexposed infants.

Fully adjusted analyses restricted the cohort to women with depression and controlled for confounding factors such as sociodemographics, multiple gestation, chronic maternal illness, use of other psychotropics or suspected teratogens, and smoking. No associations were found for antidepressant use and cardiac malformations, including a dose-response relationship; paroxetine and right ventricular outflow tract obstruction; and sertraline and ventricular septal defects. However, the well-recognized associations between cardiac malformations and maternal diabetes, antiepileptic exposure, and multiple gestation were replicated.


Studies of medication effects during pregnancy are frequently too small to allow reliable assessment of differences in risks or do not adjust for important confounders. Often with conflicting or inadequate data, clinicians treating pregnant women with severe depression must weigh the potential risks of treatment against those of no treatment. This very large study, which adjusted for important confounders, is reassuring in suggesting a lack of association between first-trimester antidepressant exposure and risk for cardiac defects.

Editor Disclosures at Time of Publication

  • Disclosures for Deborah Cowley, MD at time of publication Grant / Research support Health Resources and Services Administration Leadership positions in professional societies American Association of Directors of Psychiatric Residency Training (Co-Chair; Pre-Meeting Committee and Milestones Assessment Task Force)


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