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Grand Rounds

Meta-analysis: Ondansetron in Pregnancy and Risks for Perinatal Adverse Outcomes

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BACKGROUND AND PURPOSE:

  • Dormuth et al (JAMA Network Open, 2021) examined the use of the antiemetic ondansetron (Zofran) during pregnancy and potential risks for spontaneous abortion, stillbirth, and major congenital malformations

METHODS:

  • Cohort study with meta-analysis
  • Data sources
    • Administrative data from 5 Canadian provinces | US IBM MarketScan Research Databases | UK Clinical Practice Research Datalink
  • Participants
    • 12 to 55 years
    • History of: Spontaneous abortion | Induced abortion | Stillbirth | Live birth | Occurrence between April 2002 and March 2016
  • Exposure
    • Ondansetron
    • Other common antiemetics
  • Study design
    • Cox proportional hazards models with time-dependent drug exposures were used to estimate hazard ratio with adjusted using propensity scores (aHR)
    • For major congenital malformations, adjusted odds ratio (aOR) was estimated from logistic models
    • Site-level results were pooled using random-effects meta-analysis
  • Primary outcome
    • Fetal death (spontaneous abortion or stillbirth)
  • Secondary outcomes
    • Stillbirth
    • Spontaneous abortion
    • Major congenital malformation

RESULTS:

  • 163,810 pregnancies exposed to ondansetron | 306,766 exposed to other antiemetics
    • 54.7% from Canada | 43.3% from US | 2.0% from UK
    • Maternal age
      • ≤24 years: 20.4%
      • 25-29 years: 32.6%
      • 30-34 years: 31.2%
      • ≥35 years: 15.8%
  • Incidence of fetal death
    • Ondansetron: 7.9% of pregnancies
    • Other antiemetic exposure: 5.7%
  • There was no significant association between ondansetron exposure and
    • Fetal death: aHR 0.91 (95% CI, 0.67 to 1.23)
    • Spontaneous abortion: aHR 0.82 (95% CI, 0.64 to 1.04)
    • Stillbirth: aHR 0.97 (95% CI, 0.79 to 1.20)
    • Major congenital malformations: OR 1.06 (95% CI, 0.91 to 1.22)
  • Results did not change with subgroup analysis or timing of exposure during pregnancy

CONCLUSION:

  • By comparing to a cohort using other antiemetics, the study was able to control for nausea and vomiting as possible confounders 
  • Ondansetron exposure was not associated with increased risk for fetal death, spontaneous abortion, stillbirth, or major congenital malformations

Learn More – Primary Sources:

Comparison of Pregnancy Outcomes of Patients Treated With Ondansetron vs Alternative Antiemetic Medications in a Multinational, Population-Based Cohort

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Related ObG Topics:

Ondansetron for Nausea During Pregnancy – Is There a Risk for Birth Defects?
Safety of Intravenous Ondansetron in Pregnancy
Safety of First Trimester Ondansetron Exposure During Pregnancy

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