1. The use of antidepressants during the first trimester of pregnancy was not significantly associated with higher risk of congenital cardiac abnormalities in this large, population-based cohort study.
2. The use of paroxetine and sertraline during the first trimester were not significantly linked with higher risk of right ventricular outflow tract obstruction or ventricular septal defects, respectively.
Evidence Rating Level: 2 (Good)
Study Rundown: High rates of clinical depression have been observed in pregnant women, and the use of antidepressants during pregnancy has gradually increased over time. Previous studies have demonstrated increased risk of congenital abnormalities, particularly right ventricular outflow tract obstruction, associated with the use of paroxetine, a selective-serotonin reuptake inhibitor (SSRI) and commonly used antidepressant medication. Similarly, other studies have shown a linkage between sertraline use in pregnancy and increased risk of ventricular septal defects.
The aim of this paper, published today in The New England Journal of Medicine, was to assess the risk of congenital cardiac abnormalities associated with antidepressant use, with consideration of potential confounders. In summary, this study utilized a large national database of publicly insured pregnant individuals in the United States. The use of antidepressants in pregnant women during the first trimester was not significantly associated with higher risk of congenital cardiac abnormalities. Specifically, paroxetine use was not linked with higher risk of right ventricular outflow tract obstruction, while the use of sertraline was not associated with greater risk of ventricular septal defects.
In-Depth [cohort study]: The cohort for the study was drawn from Medicaid databases for 46 states and Washington, D.C. Several states were excluded from the analysis due to difficulties analyzing or accessing the necessary data. In order to be included in the study, women needed to be eligible for Medicaid, not have supplementary private insurance or restricted benefits, for the time period lasting between 3 months prior to the last menstrual period until 1 month after delivery. Pregnancies were excluded when infants had a diagnosis of chromosomal abnormalities (n=1609) and in cases where the mother was exposed to known teratogens during the first trimester (n=2476). All completed pregnancies were identified in individuals 12 to 55 years of age, and linked with the liveborn infants. The exposure window was defined as the date of the last menstrual period to the 90th day of pregnancy (i.e., the first trimester). The following exposures were assessed: any SSRI, paroxetine, sertraline, fluoxetine, tricyclic antidepressants, serotonin-norepinephrine reuptake inhibitors (SNRIs), buproprion, and other antidepressants. The potential confounders considered included sociodemographic factors (e.g., year of delivery, state of residency, age) and known/suspected risk factors for congenital cardiac malformations (e.g., multiple gestation, chronic maternal illness, use of suspected teratogens). Logistic regression analyses were used to estimate the odds ratios for cardiac malformations and their 95% confidence intervals.
A total of 949,504 eligible pregnancies were identified; of these, 64,389 used an antidepressant. Three levels of analysis were carried out with differing levels of adjustment. The unadjusted analysis involved the entire study cohort with no adjustment. The depression-restricted analysis was limited to women with a depression diagnosis, with the aim of accounting for differences attributable to underlying illness or linked factors. The third analysis was depression-restricted with propensity-score stratification, a method to control for the severity of depression. In the fully adjusted, the use of antidepressants during pregnancy was not shown to be linked with significantly higher risk of congenital cardiac malformations. Specifically, the use of paroxetine during pregnancy was not linked with significantly higher risk of right ventricular outflow tract obstruction (RR 1.07; 95%CI 0.59-1.93), and the use of sertraline was not associated with significantly higher risk of ventricular septal defects (RR 1.04; 95%CI 0.76-1.41).
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