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Neonatal cholestatic hepatitis from carbamazepine exposure during pregnancy and breast feeding

Bernhard Frey1, Christian P Braegger, Daniela Ghelfi

  • 1Department of Intensive Care and Neonatology, University Children's Hospital, Zurich, Switzerland. Bernhard.Frey@kispi.unizh.ch

The Annals of Pharmacotherapy
|March 29, 2002
PubMed

Insights

Carbamazepine exposure during pregnancy and breastfeeding can cause transient cholestatic hepatitis in infants. This condition requires careful monitoring and may necessitate updates to drug information for expectant mothers.

Area of Science:

  • Neonatal Hepatology
  • Pharmacovigilance
  • Pediatric Toxicology

Background:

  • Carbamazepine is a widely used antiepileptic drug with known hepatotoxic potential in adults and children.
  • The drug readily crosses the placenta and is excreted into breast milk, posing a risk to the developing fetus and neonate.

Observation:

  • A case report details an infant experiencing transient cholestatic hepatitis between 3 and 7 weeks of life.
  • The infant's mother was on carbamazepine monotherapy throughout pregnancy and breastfeeding.
  • The infant had initial transient hepatic dysfunction after birth due to asphyxia, followed by a distinct 5-week period of cholestatic hepatitis.

Findings:

  • Exclusion of infectious, metabolic, and surgical causes (e.g., biliary atresia) supported a drug-induced etiology.
  • This case, alongside two prior reports, highlights the risk of carbamazepine-induced cholestasis via transplacental and transmammary routes.
  • The findings suggest carbamazepine exposure as the likely cause of the infant's hepatitis.

Implications:

  • Carbamazepine-induced hepatitis in neonates warrants consideration in infants exposed prenatally or via breastfeeding.
  • Early recognition can prevent unnecessary and invasive diagnostic procedures in affected infants.
  • Product information for carbamazepine should be updated to include the risk of neonatal liver dysfunction.
Abstract

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