Grand Rounds

Is Acetaminophen Safe During the Third Trimester Use?

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

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

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%

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

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