Key result
First-trimester venlafaxine or duloxetine exposure shows no association with major congenital malformations.
Why the study?
Medical treatment for major depressive disorder in women of childbearing age is controversial, and significantly less data are available for newer SNRIs compared with SSRIs.
Does first-trimester in utero exposure to venlafaxine or duloxetine increase the risk of major congenital malformations?
Systematic Review
Does first-trimester in utero exposure to venlafaxine or duloxetine increase the risk of major congenital malformations?
First-trimester exposure to venlafaxine or duloxetine does not appear to be associated with a clinically important increased risk of major congenital malformations.
Supports no clinically important malformation risk with first-trimester venlafaxine or duloxetine; reinforces the evidence base for SNRI use in pregnancy.
Major depressive disorder is common among women in child-bearing age, and medical treatment is subject to substantial discussions and controversies. For Selective Serotonin reuptake inhibitors, SSRIs, a vast amount of data are available. For the newer antidepressant group of serotonin and noradrenaline reuptake inhibitors, SNRIs, significantly less data are available. Following the PRISMA guideline for systematic reviews, we performed a systematic search on the risk of major congenital malformations after first trimester in utero exposure to venlafaxine or duloxetine. We identified eight cohort studies reporting on the outcome upon in utero exposure to venlafaxine or duloxetine during the first trimester. The cumulated data for venlafaxine were 3186 exposed infants and 107 major malformations, resulting in a relative risk estimate and 95% confidence interval of 1.12 (0.92-1.35). The corresponding data for duloxetine were 668 infants and 16 major malformations, resulting in a relative risk estimate and 95% confidence interval of 0.80 (0.46-1.29). First-trimester in utero exposure to venlafaxine is not associated with an increased risk of major congenital malformations. The amount of data for duloxetine are significantly smaller but does not suggest a clinically important increased risk.
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Lassen et al. (2015) conducted a systematic review in Major depressive disorder in pregnancy. Venlafaxine or duloxetine vs. Unexposed was evaluated on Major congenital malformations (RR 1.12, 95% CI 0.92-1.35). First-trimester in utero exposure to venlafaxine (RR 1.12; 95% CI 0.92-1.35) or duloxetine (RR 0.80; 95% CI 0.46-1.29) was not associated with increased risk of major congenital malformations.
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