Pregnancy outcome after first trimester exposure to vortioxetine: A case series

Abstract Background The objective of this study was to collect outcome after vortioxetine exposure during the first trimester of pregnancy in a case series. Methods Callers who were counseled by the Israeli Teratology Information Service (TIS) regarding vortioxetine exposure during pregnancy were prospectively collected and followed‐up by telephone using a structured questionnaire. Outcomes were confirmed by a pediatrician with medical records in the neonatal period. Results Between 2016 and 2019, a total of 19 women were included in the TIS database after first trimester exposure to vortioxetine. Seventeen pregnancy follow‐ups were obtained, while two pregnancies were lost to follow‐up. Eleven pregnancies resulted in 12 live births with no malformations including one set of twins; there were three miscarriages, two terminations, and one stillbirth in week 22. One termination was performed due to prenatal diagnosis of acrania (the woman also took carbamazepine, folic acid and dipyrone), and the second due to fear of abnormalities after cystic hygroma was suspected at week 12 with nuchal translucency of 8.1 mm and no further cytogenetic testing. The twins were born in week 35. Two women continued using the medication until delivery; one of these women reported nursing her baby from birth to up to 1 year, while she continued taking vortioxetine. Discussion This case series provides preliminary outcome data on vortioxetine exposure in pregnancy. However, the small sample size calls for caution in the interpretation of results. Denominator‐based studies are needed before conclusions can be drawn.