Duloxetine in pregnancy is tied to increased maternal-fetal risks

  • Huybrechts KF & al.
  • BMJ
  • 19 Feb 2020

  • curated by Emily Willingham, PhD
  • Clinical Essentials
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Takeaway

  • Maternal use of the selective serotonin and norepinephrine reuptake inhibitor duloxetine during pregnancy is tied to increased risk for postpartum hemorrhage and cardiac malformations.

Why this matters

  • Authors say that these “relatively uncommon” outcomes should be considered against the benefits of treating depression and other targeted symptoms during pregnancy.

Key results

  • Various subcohorts consisted of 1.3-4.1 million women.
  • Exposures during pregnancy varied from about 2500-3000 for exposures during early pregnancy to 900-950 for later pregnancy exposures.
  • Baseline risk for cardiovascular malformations was 13.7 per 1000 unexposed women (95% CI, 13.5-13.9).
  • Baseline risk for postpartum hemorrhage was 23.3 per 1000 unexposed women (95% CI, 23.1-23.4).
  • Adjusted relative risk for cardiovascular malformations in exposed group was 1.29 (95% CI, 0.99-1.68).
  • This risk was not significantly different from that among women exposed to selective serotonin reuptake inhibitors.
  • Adjusted relative risk for postpartum hemorrhage was 1.53 (95% CI, 1.08-2.18).
  • Women with duloxetine exposure tended to be older and white, have more chronic conditions, use other drugs more frequently, and seek health care more.

Study design

  • Cohort study; 8,410,882 women in the United States with public insurance and their liveborn infants.
  • Subcohort sizes varied by target outcome.
  • Funding: Eli Lilly and Company.

Limitations

  • Exposure windows could have been misclassified if date of last menstrual period was miscalculated.