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Grand Rounds

Direct Oral Anticoagulant Exposure in Early Pregnancy and Risk for Birth Defects

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BACKGROUND AND PURPOSE:

  • Data regarding direct oral anticoagulant (DOAC) exposure in early pregnancy and embryotoxicity are limited
  • Beyer-Westendorf et al. (The Lancet Haematology, 2020) assessed the risk of DOAC embryotoxicity in a large sample of reported cases

METHODS:

  • Retrospective cohort study (May 2015 through December 2019)
  • Data sources
    • Collected individual reports from medical specialists (gynecologists, hematologists, and vascular specialists)
    • Pregnancy exposure reports from pharmacovigilance databases of the DOAC manufacturers | European Medicines Agency (EMA) | German drug authority | FDA and the US Food and Drug Administration (FDA)
    • ISTH registry
    • Teratology Information Service Outcomes
  • Major birth defects according to EUROCAT classification
    •  DOAC exposure (1) likely (2) possible (3) unlikely (4) unrelated

RESULTS:

  • 614 unique cases of DOAC exposures during pregnancy
    • Rivaroxaban: 82%
    • Dabigatran: 6%
    • Apixaban: 8%
    • Edoxaban: 4%
  • Median DOAC exposure: 5.3 weeks (IQR 4.0 to 7.0) into pregnancy
  • Pregnancy outcome available in 55% of pregnancies
    • Livebirth: 56%
    • Miscarriage: 22%
    • Elective pregnancy termination: 22%
  • Fetal abnormalities: 6% (95% CI 4% to 9%)
    • Major birth defects potentially related to DOAC exposure: 4% (95% CI 2% to 6%)

CONCLUSION:

  • DOAC exposure in pregnancy was not associated with higher risk of embryopathy
  • Authors note important limitations
    • Pregnancy outcomes are incomplete
    • Most reports describe rivaroxaban exposures
  • The authors state

The 2016 ISTH guidance against elective pregnancy termination for fear of DOAC embryotoxicity and the recommendation in favour of close pregnancy surveillance is still valid

Learn More – Primary Sources:

Safety of direct oral anticoagulant exposure during pregnancy: a retrospective cohort study

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