Hazel Hummels1,2, Daphne Bertholee1, Douwe van der Meer1, Jan Pieter Smit3, Bob Wilffert2,4, Peter Ter Horst5. 1. Isala, Department of Clinical Pharmacy, PO Box 10400, Dr van Heesweg 2, 8025 AB, Zwolle, The Netherlands. 2. University of Groningen, University Centre for Pharmacy, Unit of Pharmacotherapy, Epidemiology and Economics, Groningen, the Netherlands. 3. Isala Department of Psychiatry, Zwolle, The Netherlands. 4. Department of Hospital and Clinical Pharmacy, University Medical Centre Groningen, Groningen, the Netherlands. 5. Isala, Department of Clinical Pharmacy, PO Box 10400, Dr van Heesweg 2, 8025 AB, Zwolle, The Netherlands. p.g.j.ter.horst@isala.nl.
Abstract
THE AIM OF THE STUDY: 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. MATERIALS AND 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. CONCLUSION: 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.
THE AIM OF THE STUDY: 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. MATERIALS AND 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. CONCLUSION: 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.
Entities:
Keywords:
Asthma; Breastfeeding; Food and Drug Administration
Authors: Zachary N Stowe; Amy L Hostetter; Michael J Owens; James C Ritchie; Kevan Sternberg; Lee S Cohen; Charles B Nemeroff Journal: J Clin Psychiatry Date: 2003-01 Impact factor: 4.384