The quality of lactation studies including antipsychotics

Hummels, H., Bertholee, D., van der Meer, D., Smit, J. P., Wilffert, B. & ter Horst, P., Dec-2016, In : European Journal of Clinical Pharmacology. 72, 12, p. 1417-1425 9 p.

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  • The quality of lactation studies including antipsychotics

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  • Hazel Hummels
  • Daphne Bertholee
  • Douwe van der Meer
  • Jan Pieter Smit
  • Bob Wilffert
  • Peter ter Horst

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.

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.

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.

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.

Original languageEnglish
Pages (from-to)1417-1425
Number of pages9
JournalEuropean Journal of Clinical Pharmacology
Issue number12
Early online date24-Aug-2016
Publication statusPublished - Dec-2016

ID: 35563304