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SSRIs and Birth Defects — How Concerned Should Our Patients Be?

New information clarifies that SSRIs are not major teratogens.

SSRIs are often prescribed for depression, a relatively common condition among women of reproductive age; thus, whether SSRI use increases the risk for birth defects is an important issue. Earlier reports have suggested that use of SSRIs (particularly paroxetine) during early pregnancy is associated with an increased risk for heart defects. Reports from two large ongoing case-control studies provide new data on the risks associated with prenatal exposure to SSRIs.

Investigators from the CDC and the University of British Columbia studied 9622 case infants with major birth defects (identified through birth-defect surveillance systems in 8 states) and 4092 controls born from 1997 through 2002. Overall, the authors observed no significant associations between maternal SSRI use during early pregnancy and congenital heart defects or most other categories of birth defects. Specifically, maternal SSRI use was associated with anencephaly (odds ratio, 2.4; 95% confidence interval, 1.1–5.1), craniosynostosis (OR, 2.5; 95% CI, 1.5–4.0), and omphalocele (OR, 2.8; 95% CI, 1.3–5.7). Paroxetine use in particular correlated with higher pooled ORs for these three major birth defects and with a significantly increased risk for right ventricular outflow tract obstruction defects.

In a second study, investigators funded by the manufacturer of paroxetine and by the NIH studied 9849 case infants and 5860 controls born in the U.S. and Canada from 1993 through 2005. Overall, SSRI use was not associated with risk for heart defects, craniosynostosis, or omphalocele. However, paroxetine use correlated with a significantly increased risk for right ventricular outflow tract obstruction defects. The authors of both studies pointed out that the absolute risks associated with SSRI use during pregnancy were small in relation to the risk for birth defects in the general population.

Comment: As an editorialist notes, these two new reports clarify that SSRIs are not major teratogens. This information, taken together with the risks associated with discontinuing an SSRI during pregnancy, should help affected women make decisions regarding the management of their depression. For women taking SSRIs during early pregnancy, targeted second-trimester ultrasound to evaluate for anomalies would be appropriate. Women who choose to discontinue their SSRIs during or just before pregnancy likely will benefit from psychiatric monitoring (Journal Watch Women’s Health Apr 26 2007).

— Andrew M. Kaunitz, MD

Published in Journal Watch Women's Health June 27, 2007

Citation(s):

Alwan S et al. Use of selective serotonin-reuptake inhibitors in pregnancy and the risk of birth defects. N Engl J Med 2007 Jun 28; 356:2684-92.

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Louik C et al. First-trimester use of selective serotonin-reuptake inhibitors and the risk of birth defects. N Engl J Med 2007 Jun 28; 356:2675-83.

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Greene MF. Teratogenicity of SSRIs — Serious concern or much ado about little? N Engl J Med 2007 Jun 28; 356:2732-3.

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• Medline abstract (Free)