Rates of major malformations in infants following exposure to duloxetine during pregnancy: a preliminary report.

To the Editor: There are no published prospective, comparative studies examining the safety of duloxetine in pregnancy, and, to date, there are only 2 case reports describing its use in pregnancy: (1) a 29-year-old woman was treated with duloxetine for depression during the second half of pregnancy and gave birth to a full-term healthy infant,1 and (2) an infant was observed after birth with signs of possible poor neonatal adaptation, following exposure in utero to duloxetine in late pregnancy.2 Here, we report the results of an international collaboration designed to evaluate the safety of this medication during pregnancy. Our main objective was to determine whether the use of duloxetine during the first trimester of pregnancy is associated with an increased risk for major malformations above the baseline of 1%–3%.