title: Drowsiness and poor feeding in a breast-fed infant: association with nefazodone and its metabolites.
abstract: OBJECTIVE
  To investigate whether adverse effects in a premature neonate could be attributed to nefazodone exposure via breast milk.
  
  
  METHODS
  The breast-fed white infant (female, 2.1 kg, 36 weeks corrected gestational age) of a 35-year-old woman (60 kg) taking nefazodone 300 mg/d was admitted to the hospital because she was drowsy, lethargic, unable to maintain normal body temperature, and was feeding poorly. A diagnosis of exposure to nefazodone via breast milk was considered only after other more likely diagnoses had been excluded. After breast feeding was discontinued, the infant's symptoms resolved slowly over a period of 72 hours. The maternal plasma and milk concentration-time profiles for nefazodone and its metabolites, triazoledione, HO-nefazodone, and m-chlorphenylpiperazine, were quantified by HPLC. The calculated infant dose for nefazodone and its active metabolites (as nefazodone equivalents) via the milk was only 0.45% of the weight-adjusted maternal nefazodone daily dose.
  
  
  CONCLUSIONS
  Our data suggest a putative association between maternal nefazodone ingestion and adverse effects in a premature breast-fed neonate. The measured amount of drug exposure would normally be considered safe in a full-term infant. However, there was a temporal relationship between resolution of adverse effects in the infant and cessation of breastfeeding.
  
  
  CONCLUSIONS
  This case highlights the importance of individualizing the risk-benefit analysis for exposure to antidepressants in breast milk, especially when dealing with premature neonates.
authors.affiliation: Pharmacy Department, King Edward Memorial Hospital, Subiaco, Western Australia. patrick.yapp@health.wa.gov.au
authors.forename: P
authors.initials: P
authors.lastname: Yapp
authors.forename: K F
authors.initials: KF
authors.lastname: Ilett
authors.forename: J H
authors.initials: JH
authors.lastname: Kristensen
authors.forename: L P
authors.initials: LP
authors.lastname: Hackett
authors.forename: M J
authors.initials: MJ
authors.lastname: Paech
authors.forename: J
authors.initials: J
authors.lastname: Rampono
mesh_terms: D000328:Adult; D018687:Antidepressive Agents, Second-Generation / Q000009:adverse effects* / Q000378:metabolism; D019540:Area Under Curve; D001942:Breast Feeding; D019052:Depression, Postpartum / Q000188:drug therapy*; D005247:Feeding Behavior / Q000187:drug effects*; D005260:Female; D006801:Humans; D007231:Infant, Newborn; D007234:Infant, Premature; D008895:Milk, Human / Q000737:chemistry*; D010879:Piperazines; D012894:Sleep Stages / Q000187:drug effects*; D014230:Triazoles / Q000009:adverse effects* / Q000378:metabolism / Q000493:pharmacokinetics
chemical_list: D018687:Antidepressive Agents, Second-Generation; D010879:Piperazines; D014230:Triazoles; C051752:nefazodone