The quality of lactation studies including antipsychotics
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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.
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.
KeywordsBreastfeeding Asthma Food and Drug Administration
- 2.Ip S, Chung M, Raman G, Chew P, Magula N, DeVine D, et al. (2007) Breastfeeding and maternal and infant health outcomes in developed countries. Evid Rep Technol Assess (Full Rep) (153):1–186Google Scholar
- 3.World Health Organisation and UNICEF (2003) Global strategy for infant and young child feedingGoogle Scholar
- 4.World Health Organisation (2009) Infant and young child feeding. Model chapter for textbooks for medical students and allied health professionalsGoogle Scholar
- 5.Infant care (2014) Increase the proportion of infants who are ever breastfed [Internet]. Available from: http://www.healthypeople.gov/2020/topics-objectives/topic/maternal-infant-and-child-health/objectives
- 6.Hale TW (2014) Medications and mothers’ milk. Hale Publishing, AmarilloGoogle Scholar
- 8.Barnes TR (2011) Schizophrenia consensus Group of British Association for psychopharmacology. Evidence-based guidelines for the pharmacological treatment of schizophrenia: recommendations from the British Association for Psychopharmacology. J Psychopharmacol 25(5):567–620CrossRefPubMedGoogle Scholar
- 22.Neville MC WC (1996) Effects of drugs on milk secretion and composition. In: Bennett PN, editor. Drugs and Human Lactation. Elsevier. p. 15–46Google Scholar
- 23.Polin RA, Abman SH, Rowitch D, Benitz WE (2011) Fetal and neonatal physiology. Elsevier Saunders, Philadelphia, p. 292Google Scholar
- 24.Food and Drug Administration (2005) Clinical lactation studies – study design, data analysis and recommendations for labelingGoogle Scholar
- 31.Yoshida K, Smith B, Craggs M (1998) Neuroleptic drugs in breast-milk: a study of pharmacokinetics and of possible adverse effects in breast-fed infants. PsycholMed 28:81–91Google Scholar
- 32.Sugawara K, Shimoyama R, Ohkubo T (1999) Determinations of psychotropic drugs and antiepileptic drugs by high-performance liquid chromatography and its monitoring in human breast milk. Hirosaki Med J 51(Suppl):S81–S86Google Scholar
- 46.Uhlir F, Ryznar J (1973) Appearance of chlorpromazine in the mother’s milk. Acta Nerv Super (Praha) 15:106Google Scholar
- 48.Ohkubo T, Shimoyama R, Sugawara K (1993) Determination of chlorpromazine in human breast milk and serum by high-performance liquid chromatography. J Chromatogr 614(328):332Google Scholar
- 65.Yazdani-Brojeni P, Taguchi N, Garcia-Bournissen F, Moretti M, Verjee Z, Koren G, et al. (2010) Quetiapine in human milk and stimulation-based assessment of infant exposure. Clin Pharmacol Ther 87(Suppl 1):S3–S4Google Scholar
- 66.Tanoshima R, Yazdani-Brojeni P, Taguchi N, Garcia-Bournissen F, Moretti M, Verjee Z, et al. (2012) Quetiapine in human breast milk—population PK analysis of milk levels and simulated infant exposure. J Popul Ther Clin Pharmacol 19:e267–e268Google Scholar
- 75.Ohman I, Tomson T (2011) Pharmacokinetics of zonisamide in neonatal period and during lactation. Basic Clin Pharmacol Toxicol 109(Suppl 1):73Google Scholar
- 78.Bennett PN (1996) Use of monographs on drugs. In: Bennett PN (ed) Drugs and human lactation. Elsevier, Amsterdam, pp. 67–74Google Scholar