Duloxetine (sold in the United Sates under the brand name of Cymbalta) is a serotonin-norepinephrine reuptake inhibitor (SNRI) effective for major depressive disorder and generalized anxiety disorder (GAD).  Although used fairly commonly in women of child-bearing age, information regarding its reproductive safety has been lacking.

In a recent multicenter cohort study, data on duloxetine exposure were collected prospectively from either women or their health care providers who had requested information regarding the use of duloxetine during pregnancy.  During the initial contact, demographics, medical and obstetric histories, and details of drug exposure, as well as concurrent exposures to other substances, were recorded.  Approximately 2 to 3 months after delivery, research assistants contacted women who had taken duloxetine during pregnancy. 

The study included two comparison groups: (1) women who were inquiring about exposure to other antidepressants (n=208) and (2) women inquiring about an exposure to medications not considered to be teratogens, such as acetaminophen (n=208).

Data was collected on a total of 208 duloxetine-exposed pregnancies. Rates of major malformations were similar between the 3 groups. There were 165 live births and 3 malformations (1.8%) in the duloxetine group (clubfoot, kidney agenesis, and hydronephrosis). Two women (1.0%) took duloxetine only in the second or third trimester.

While this study is reassuring, its main limitation is its small sample size.  The authors note that approximately 750 subjects in each group would be required to detect a 2-fold increase in major malformations, and thousands would be required to detect rare anomalies.  Despite these limitations, the results suggest that duloxetine does not appear to increase the rate of major malformations above baseline.

Ruta Nonacs, MD PhD

Einarson A, Smart K, Vial T, et al.  Rates of Major Malformations in Infants Following Exposure to Duloxetine During Pregnancy: A Preliminary Report. J Clin Psychiatry 2012;73(11):1471.

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