title: Duloxetine transfer across the placenta during pregnancy and into milk during lactation.
abstract: OBJECTIVE
  Duloxetine is an efficacious antidepressant; however, its safety during the perinatal period is uncertain. The objective of this study was to assess the transfer across the placenta and provide data on infant exposure to duloxetine via breast milk.
  
  
  METHODS
  A multiparous 31-year-old woman with recurrent melancholic depression had responded poorly to previous antidepressants, but had a full remission on duloxetine. She elected to remain on duloxetine for her third pregnancy and while breastfeeding. She gave birth to a healthy term infant and there were no adverse events noted for the infant exposed to duloxetine. Duloxetine concentration was measured chromatographically in maternal and infant serum collected at birth, and in maternal milk and plasma and infant plasma 18 days later, (C/M) concentration ratio was calculated. Absolute and relative infant doses via milk were estimated and the percent drug in infant versus mother's plasma was calculated.
  
  
  RESULTS
  Cord/maternal serum concentration ratio for duloxetine was 0.12. Absolute infant dose via milk was 7.6 μg/L and relative infant dose was 0.81%. The ratio of drug in the infant's plasma to that in maternal plasma during lactation also gave a 0.82% infant exposure estimate.
  
  
  CONCLUSIONS
  The low C/M ratio suggests a limited transfer across the placenta. The relative infant dose via milk was low by comparison to most other antidepressants, and this estimate confirmed the amount of drug in infant plasma during lactation. Our data suggest that duloxetine may be used in pregnancy and lactation for selected patients in whom other antidepressants have not been successful.
authors.affiliation: Discipline of Psychiatry, Western Clinical School, Sydney Medical School, The University of Sydney, Westmead Hospital, Wentworthville, NSW, Australia. philip.boyce@sydney.edu.au
authors.forename: Philip M
authors.initials: PM
authors.lastname: Boyce
authors.forename: L Peter
authors.initials: LP
authors.lastname: Hackett
authors.forename: Kenneth F
authors.initials: KF
authors.lastname: Ilett
mesh_terms: D000328:Adult; D000928:Antidepressive Agents / Q000008:administration & dosage / Q000097:blood / Q000493:pharmacokinetics*; D003865:Major Depressive Disorder / Q000188:drug therapy; D004305:Dose-Response Relationship, Drug; D000068736:Duloxetine Hydrochloride; D005260:Female; D006801:Humans; D007774:Lactation; D008895:Milk, Human / Q000187:drug effects* / Q000378:metabolism; D010920:Placenta / Q000187:drug effects*; D011247:Pregnancy; D013876:Thiophenes / Q000008:administration & dosage / Q000097:blood / Q000493:pharmacokinetics*
chemical_list: D000928:Antidepressive Agents; D013876:Thiophenes; D000068736:Duloxetine Hydrochloride