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Antidepressant use in pregnancy and the risk of cardiac defects.

As the use of antidepressants during pregnancy has increased, prevalence rates in the United States have reached 8% to 13%. Selective serotonin-reuptake inhibitors (SSRIs) are the most commonly prescribed antidepressants during pregnancy. Various associations between drug use and fetal congenital cardiac malformations have been reported. This cohort study was undertaken to assess the risk of congenital cardiac defects after parturient use of antidepressants. Cohort data were drawn from the Medicaid Analytic eXtract for 2000 to 2007, which includes individual-level demographic and Medicaid enrollment information and data on all filled outpatient medication prescriptions within 46 States and Washington, DC. The data for women who were exposed to SSRIs during the first trimester were extracted. Exposure categories were any SSRI, paroxetine, sertraline, fluoxetine, tricyclic antidepressants (TCAs), serotonin-norepinephrine reuptake inhibitors (SNRIs), bupropion, and other antidepressants. Parturients without antidepressant use during the first trimester were the reference group. Congenital cardiac malformations included any cardiac malformation, right ventricular outflow tract obstruction, ventricular septal defect, and other cardiac malformations. Covariates included sociodemographic information; known or suspected risk factors for congenital cardiac malformations; use of teratogenic, other psychotropic, antidiabetic, and antihypertensive medications; and number of distinct prescription drugs used. Among 949,504 eligible pregnancies, 64,389 women (6.8%) used an antidepressant during the first trimester. A total of 46,144 women (4.9%) were exposed to an SSRI, 5954 (0.6%) to a TCA, 6904 (0.7%) to an SNRI, 8856 (0.9%) to bupropion, and 7055 (0.7%) to other antidepressants. Sertraline was used by 14,040 women, paroxetine by 11,126, and fluoxetine by 11,048. Cardiac malformations were diagnosed in 6403 infants not exposed to an antidepressant during the first trimester (72.3 cardiac malformations/10,000 infants) and in 580 exposed infants (90.1 cardiac malformations/10,000 infants). This higher unadjusted risk among exposed infants was seen for each type of malformation noted above. In the unadjusted analyses, the relative risk (RR) of any cardiac malformation was 1.25 with SSRIs [95% confidence interval (CI), 1.13-1.38], 0.98 with TCAs (95% CI, 0.72-1.32), 1.51 with SNRIs (95% CI, 1.20-1.90), 1.19 with bupropion (95% CI, 0.95-1.49), and 1.46 with other antidepressants (95% CI, 1.16-1.83). The propensity score-adjusted RR of any cardiac malformation was 1.06 among women given SSRIs (95% CI, 0.93-1.22), 0.77 for TCAs (95% CI, 0.52-1.14), 1.20 for SNRIs (95% CI, 0.91-1.57), 0.92 for bupropion (95% CI, 0.69-1.22), and 1.21 for other antidepressants (95% CI, 0.91-1.60). No significant associations were found between paroxetine and right ventricular outflow tract obstruction (RR, 1.07; 95% CI, 0.59-1.93) nor between sertraline and ventricular septal defect (RR, 1.04; 95% CI, 0.76-1.41). The RR of cardiac malformations associated with SSRI use for those on antidepressant monotherapy was 1.04 (95% CI, 0.90-1.21) and for polytherapy was 1.17 (95% CI, 0.90-1.53). RRs for associations between cardiac malformations and maternal diabetes, use of an anticonvulsant agent, and multifetal pregnancy were 3.7, 1.6, and 2.9, respectively (95% CI, 3.44.0; 95% CI, 1.3-1.8; and 95% CI, 2.8-3.1, respectively). These results fail to support previous reports of an association between antidepressant use and cardiac anomalies. Evidence implies low absolute risks and argues against important cardiac teratogenic effects associated with the most commonly used antidepressants.