First-Trimester Pregnancy Exposure to Venlafaxine or Duloxetine and Risk of Major Congenital Malformations: A Systematic Review

Basic Clin Pharmacol Toxicol. 2016 Jan;118(1):32-6. doi: 10.1111/bcpt.12497. Epub 2015 Nov 3.

Abstract

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.

Publication types

  • Review
  • Systematic Review

MeSH terms

  • Abnormalities, Drug-Induced / epidemiology
  • Abnormalities, Drug-Induced / etiology*
  • Cohort Studies
  • Depressive Disorder, Major / drug therapy
  • Duloxetine Hydrochloride / administration & dosage
  • Duloxetine Hydrochloride / adverse effects*
  • Duloxetine Hydrochloride / therapeutic use
  • Female
  • Humans
  • Pregnancy
  • Pregnancy Trimester, First
  • Prenatal Exposure Delayed Effects / chemically induced*
  • Prenatal Exposure Delayed Effects / epidemiology
  • Serotonin and Noradrenaline Reuptake Inhibitors / administration & dosage
  • Serotonin and Noradrenaline Reuptake Inhibitors / adverse effects*
  • Serotonin and Noradrenaline Reuptake Inhibitors / therapeutic use
  • Venlafaxine Hydrochloride / administration & dosage
  • Venlafaxine Hydrochloride / adverse effects*
  • Venlafaxine Hydrochloride / therapeutic use

Substances

  • Serotonin and Noradrenaline Reuptake Inhibitors
  • Venlafaxine Hydrochloride
  • Duloxetine Hydrochloride