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Grand Rounds

Is Acetaminophen Safe During the Third Trimester Use?

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BACKGROUND AND PURPOSE:

  • Acetaminophen (paracetamol) is the medication of choice for treating pain and fever in pregnancy
    • However, recent studies suggest an association between acetaminophen and adverse fetal events including ductus arteriosus closure and oligohydramnios
  • Dathe et al. (BJOG, 2019) estimated the frequency of clinically relevant cardiovascular or renal adverse events in fetuses/infants exposed to acetaminophen prenatally

METHODS:

  • Observational cohort study and retrospective case assessment
    • The Embryotox ‘adverse drug reaction in pregnancy’ database was screened for cases of fetotoxicity
  • Setting
    • Germany, 2008–2017
  • Participants
    • Exposure to acetaminophen
    • Exclusion: Exposure to NSAIDs in the second or third trimester
  • Interventions
    • Exposure to acetaminophen in the third trimester
    • Exposure to acetaminophen in the first and/or second trimester only
  • Primary outcomes
    • Prenatal outcomes
      • Narrowing or closure of ductus arteriosus | Late fetal death | Oligohydramnios
    • Postnatal outcomes
      • Patent ductus arteriosus (PDA) | Primary pulmonary hypertension (PPHT) | Impaired renal function

RESULTS:

  • Third trimester group: 604 pregnancies
  • First and second trimester group: 1192 pregnancies
  • Fetal closure of ductus arteriosus
    • No events in either group
  • Oligohydramnios
    • Rates similar in both groups
    • Third trimester group: 1.3%
    • First and second trimester group: 1.6%
  • Stillbirth
    • Rates similar in both group
    • Third trimester group: 0.2%
    • First and second trimester group: 0.3%
  • Neonatal closure of ductus arteriosus
    • Rates similar in both group
    • Third trimester group: 0.7%

First and second trimester group: 0.7%

  • PPHT and postnatal renal disorders
    • One in each group

CONCLUSION:

  • The authors conclude that

Fetal cardiovascular or renal toxicity of maternal third‐trimester paracetamol use appears to be negligible

Learn More – Primary Sources:

Negligible risk of prenatal ductus arteriosus closure or fetal renal impairment after thirdtrimester paracetamol use: evaluation of the German Embryotox cohort

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Related ObG Topics:

How Well Does IV Acetaminophen Control Post-Op Cesarean Pain?
NSAIDs in Pregnancy: Is There an Association with Miscarriage?
What are the Consequences of Taking Triptan for Migraine During Pregnancy?

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