Titre
Safety of medicines during breastfeeding - from case report to modeling: a contribution from the ConcePTION project.
Type
synthèse (review)
Institution
UNIL/CHUV/Unisanté + institutions partenaires
Auteur(s)
Cardoso, E.
Co-première auteure/Co-premier auteur
Guidi, M.
Co-première auteure/Co-premier auteur
Nauwelaerts, N.
Auteure/Auteur
Nordeng, H.
Auteure/Auteur
Teil, M.
Auteure/Auteur
Allegaert, K.
Auteure/Auteur
Smits, A.
Auteure/Auteur
Gandia, P.
Auteure/Auteur
Edginton, A.
Auteure/Auteur
Ito, S.
Auteure/Auteur
Annaert, P.
Co-dernière auteure/Co-dernier auteur
Panchaud, A.
Co-dernière auteure/Co-dernier auteur
Liens vers les personnes
Liens vers les unités
ISSN
1744-7607
Statut éditorial
Publié
Date de publication
2023
Volume
19
Numéro
5
Première page
269
Dernière page/numéro d’article
283
Peer-reviewed
Oui
Langue
anglais
Notes
Publication types: Case Reports ; Journal Article ; Review
Publication Status: ppublish
Publication Status: ppublish
Résumé
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 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.
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.
PBPK and popPK modeling are promising approaches to fill the gap in knowledge of medicine safety in breastfeeding, as illustrated with our escitalopram example.
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.
PBPK and popPK modeling are promising approaches to fill the gap in knowledge of medicine safety in breastfeeding, as illustrated with our escitalopram example.
PID Serval
serval:BIB_FDFE0C5041A6
PMID
Date de création
2023-06-08T13:20:24.329Z
Date de création dans IRIS
2025-05-21T05:53:38Z