Safety of medicines during breastfeeding - from case report to modeling : A contribution from the ConcePTION project.

Cardoso, Evelina; Guidi, Monia; Nauwelaerts, Nina; Nordeng, Hedvig; Teil, Marie; Allegaert, Karel; Smits, Anne; Gandia, Peggy; Edginton, Andrea; Ito, Shinya; Annaert, Pieter; Panchaud, Alice (2023). Safety of medicines during breastfeeding - from case report to modeling : A contribution from the ConcePTION project. Expert opinion on drug metabolism & toxicology, 19(5), pp. 269-283. Taylor & Francis 10.1080/17425255.2023.2221847

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INTRODUCTION

Despite many research efforts, current data on the safety of medicines during breastfeeding are either fragmented or lacking, resulting in restrictive labeling of most medicines. In the absence of pharmacoepidemiologic safety studies, risk estimation for breastfed infants is mainly derived from pharmacokinetic (PK) information on the medicine. This manuscript provides a description and a comparison of the different methodological approaches that can yield reliable information on medicine transfer into human milk and the resulting infant exposure.

AREA COVERED

Currently, most information on medicine transfer in human milk relies on case reports or traditional PK studies, which generate data that can hardly be generalized to the population. Some methodological approaches, such as population PK (popPK) and physiologically-based PK (PBPK) modeling, can be used to provide a more complete characterization of infant medicine exposure through human milk and simulate the most extreme situations, while decreasing the burden of sampling in breastfeeding women.

EXPERT OPINION

PBPK and popPK modeling are promising approaches to fill the gap of knowledge in medicine safety in breastfeeding, as illustrated with our escitalopram example.

Item Type:	Journal Article (Review Article)
Division/Institute:	04 Faculty of Medicine > Medical Education > Institute of General Practice and Primary Care (BIHAM)
UniBE Contributor:	Panchaud Monnat, Alice Elke Martine
Subjects:	600 Technology > 610 Medicine & health 300 Social sciences, sociology & anthropology > 360 Social problems & social services
ISSN:	1744-7607
Publisher:	Taylor & Francis
Language:	English
Submitter:	Pubmed Import
Date Deposited:	05 Jun 2023 12:25
Last Modified:	13 Jul 2023 00:15
Publisher DOI:	10.1080/17425255.2023.2221847
PubMed ID:	37269321
Uncontrolled Keywords:	Breastfed infants Breastfeeding Drug exposure Human milk Pharmacokinetics Physiologically-based pharmacokinetics
URI:	https://boris.unibe.ch/id/eprint/183170