Danish study links Zoloft, SSRIs in pregnancy to birth defects

A new study investigating the relationship between taking SSRI antidepressants during pregnancy and fetal heart abnormalities has been published by a team of researchers in Denmark. The results of the nationwide study supported findings of two previous Danish studies; that children of mothers who took SSRI antidepressants during the first trimester of pregnancy have a 200% increased the risk of heart defects. The drugs studied were Zoloft, Prozac, Lexapro, Celexa, and Paxil.

The study is based on data from 849,000 pregnancies in Denmark during the period from 1997 to 2009. Of these pregnancies, approximately 4,200 were exposed to an SSRI antidepressant throughout the first trimester, defining it as continuous exposure to the same SSRI between at least 1 month before conception and day 84 of pregnancy (last day of the first trimester). Women who changed SSRIs within the first trimester were excluded from the study.

A control group was comprised of about 800 women with “paused exposure” to an SSRI. Researchers defined “paused exposure as exposure to an SSRI 3–12 months before conception and 1–12 months after giving birth, but with no exposure to an SSRI between 3 months before conception to 1 month after giving birth.” Just as in the study group, women who changed SSRIs during the study period were excluded.

Researchers identified a link between use of an SSRI antidepressant during pregnancy and birth defects, including craniosynostosis (a skull defect), digestive system malformations and heart defects. The rate of major congenital birth defects among pregnancies exposed to any SSRI throughout the first trimester was 50 per 1000 pregnancies, compared with 35 per 1000 unexposed pregnancies. The rate of major birth defects among pregnancies with paused exposure during pregnancy also was significantly higher than normal, occurring in 45 per 1000 pregnancies in which an SSRI was used within a few months before conception.

The study found a specific association between use of an SSRI in pregnancy to septal defects of the heart. An increased risk of ventricular septal defects (VSD) and atrial septal defects (ASD) were found. VSD was associated with use of Zoloft during pregnancy, but not the other SSRI antidepressant drugs studied. The link between antidepressant use during pregnancy and birth defects was found for all of the drugs studied; Zoloft, Prozac, Lexapro, Celexa, and Paxil. The dosage of the drug was not found to be significant with regard to the birth defects risk. “Our analyses showed an increased risk of congenital heart defects for the individual SSRIs. Risks of atrial septal defects were furthermore associated with exposure to all individual SSRIs, except for escitalopram [Lexapro],” the researchers said. The researchers “found no association between congenital malformations and exposure to non-SSRI antidepressants.”

The number of major birth defects observed in the study may be much lower than the number of birth defects that occurred in the group study. The researchers explain: “Pregnant women exposed to SSRIs are reported to have increased rates of observed malformations due to increased rates of ultrasound examinations compared with women not treated with SSRIs. In contrast, detection of a malformation during an ultrasound examination could lead to pregnancy termination and thereby decreased rates of malformations among the SSRI exposed.”

Based on their findings, the authors concluded that the risk versus benefit should be evaluated for every individual patient considering use of an SSRI antidepressant during pregnancy.

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The use of SSRI antidepressants such as Zoloft during pregnancy increases the risk of heart defects and other birth defects.

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