Maternal and fetal outcomes following exposure to duloxetine in pregnancy: cohort study
Duloxetine exposure during the etiologically relevant time window, compared with no exposure to duloxetine, exposure to selective serotonin reuptake inhibitors, exposure to venlafaxine, and exposure to duloxetine before but not during pregnancy.
The number of women exposed to duloxetine varied by cohort and exposure contrast and was around 2500-3000 for early pregnancy exposure and 900-950 for late pregnancy exposure. The base risk per 1000 unexposed women was 36.6 for congenital malformations overall, 13, or cardiovascular malformations, 107.8 for preterm birth, 20.4 for small for gestational age infant, 33.6 for pre-eclampsia, and 23.3 for postpartum hemorrhage. After adjustment for measured potential confounding variables, all baseline characteristics were well balanced for all exposure contrasts. In propensity score adjusted analyses versus unexposed pregnancies, the relative risk was 1.11 for congenital malformations overall and 1.29 for cardiovascular malformations. For preterm birth, the relative risk was 1.01 for early exposure and 1.19 for late exposure. For small for gestational age infants the relative risks were 1.14 (0.92 to 1.41) and 1.20 for early and late pregnancy exposure, respectively, and for pre-eclampsia they were 1.12 and 1.04. The relative risk for postpartum hemorrhage was 1.53. Note a relative risk of 1.00 means it is the same risk as the general population. A relative risk, for example, of 1.07 means the risk is 7% higher than the general population.