Pregnancy Outcomes After First-Trimester Exposure to Vortioxetine

PURPOSE: Vortioxetine is an antidepressant used to treat major depressive disorder (MDD), a disorder that is common among women of reproductive age. To date, the reproductive safety of vortioxetine in humans has been limited. We sought to provide preliminary systematic data from the Massachusetts General Hospital National Pregnancy Registry for Psychiatric Medications (NPRPM) on the risk of major malformations after exposure to vortioxetine in the first trimester of pregnancy. MATERIALS AND METHODS: The NPRPM is a longitudinal, ongoing study in which pregnant women with psychiatric disorders are enrolled to prospectively assess for major congenital malformations after in utero exposure to psychotropics. Data regarding women who took vortioxetine during the first trimester were extracted from the NPRPM database. Data for this analysis were assessed as rigorously ascertained case series to determine the incidence of major malformations. The primary outcome of major malformations following first-trimester exposure was obtained by maternal postpartum interview and medical record review and adjudicated by a dysmorphologist blinded to exposure status. RESULTS: As of March 26, 2026, 56 women who reported taking vortioxetine during the first trimester had evaluable data. Among this sample, there were no major malformations. CONCLUSIONS: These preliminary data represent the only rigorous and prospectively ascertained pregnancy outcomes after first-trimester vortioxetine exposure. No major malformations were observed. While these data are reassuring, the relatively small sample size limits conclusions on the safety of vortioxetine in pregnancy.