title: The quality of lactation studies including antipsychotics.
abstract: OBJECTIVE
  The aim of this study is to determine the quality of lactation studies that investigated antipsychotics in breast milk according to the Food and Drug Administration (FDA) and International Lactation Consultant Association (ILCA) draft guidelines.
  
  
  METHODS
  We used the draft FDA and ILCA guidelines to review the quality of articles including antipsychotic use during breastfeeding. We used PubMed and Lactmed for the literature search. Furthermore, cross references were searched for additional studies.
  
  
  RESULTS
  Of the 51 studies, only one olanzapine and one quetiapine study calculated the milk to plasma ratio (M:P ratio), the Absolute Infant Dose (AID), and the Relative Infant Dose (RID) correctly. In the remaining studies, at least one of the three endpoints was not determined properly. No correct endpoints were calculated in studies containing chlorpromazine, chlorprothixene, clozapine, haloperidol, sulpiride, trifluoperazine, ziprasidone, zonisamide, and zuclopenthixol. This review investigated that there was a lack of information on the sampling methods of breast milk. Furthermore, the concentrations needed for the calculations of the three endpoints were mainly based on single measurements instead of at least five measurements during one dose interval. In many studies, the RID was not calculated correctly due to the fact that the RID was not normalized by the maternal weight or an average maternal weight of 70 kg was used as a standard.
  
  
  CONCLUSIONS
  Except for two studies, most studies about the safety of antipsychotic use during lactation did not meet the criteria of the draft FDA and ILCA guidelines. Further research is mandatory to assess the safety of using antipsychotics while breastfeeding.
authors: Isala, Department of Clinical Pharmacy, PO Box 10400, Dr van Heesweg 2, 8025 AB, Zwolle, The Netherlands.|University of Groningen, University Centre for Pharmacy, Unit of Pharmacotherapy, Epidemiology and Economics, Groningen, the Netherlands.
authors: Hazel
authors: H
authors: Hummels
authors: Isala, Department of Clinical Pharmacy, PO Box 10400, Dr van Heesweg 2, 8025 AB, Zwolle, The Netherlands.
authors: Daphne
authors: D
authors: Bertholee
authors: Isala, Department of Clinical Pharmacy, PO Box 10400, Dr van Heesweg 2, 8025 AB, Zwolle, The Netherlands.
authors: Douwe
authors: D
authors: van der Meer
authors: Isala Department of Psychiatry, Zwolle, The Netherlands.
authors: Jan Pieter
authors: JP
authors: Smit
authors: University of Groningen, University Centre for Pharmacy, Unit of Pharmacotherapy, Epidemiology and Economics, Groningen, the Netherlands.|Department of Hospital and Clinical Pharmacy, University Medical Centre Groningen, Groningen, the Netherlands.
authors: Bob
authors: B
authors: Wilffert
authors: Isala, Department of Clinical Pharmacy, PO Box 10400, Dr van Heesweg 2, 8025 AB, Zwolle, The Netherlands. p.g.j.ter.horst@isala.nl.
authors: Peter
authors: P
authors: Ter Horst
mesh_terms: D014150:Antipsychotic Agents / Q000097:blood / Q000493:pharmacokinetics* / Q000627:therapeutic use; D000068598:Data Accuracy; D005260:Female; D006801:Humans; D007774:Lactation / Q000378:metabolism*; D008895:Milk, Human / Q000737:chemistry*; D012107:Research Design
chemical_list: D014150:Antipsychotic Agents
keywords: Asthma; Breastfeeding; Food and Drug Administration