Breastfeeding, pregnancy, medicines, neurodevelopment, and population databases: the information desert

Jordan, Sue; Bromley, Rebecca; Damase-Michel, Christine; Given, Joanne; Komninou, Sophia; Loane, Maria; Marfell, Naomi; Dolk, Helen

doi:10.1186/s13006-022-00494-5

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Breastfeeding, pregnancy, medicines, neurodevelopment, and population databases: the information desert

Sue Jordan

, Rebecca Bromley, Christine Damase-Michel, Joanne Given, Sophia Komninou

, Maria Loane, Naomi Marfell, Helen Dolk

International Breastfeeding Journal, Volume: 17, Issue: 1

Swansea University Authors: Sue Jordan , Sophia Komninou , Naomi Marfell

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DOI (Published version): 10.1186/s13006-022-00494-5

Abstract

BackgroundThe pharmacoepidemiology of the long-term benefits and harms of medicines in pregnancy and breastfeeding has received little attention. The impact of maternal medicines on children is increasingly recognised as a source of avoidable harm. The focus of attention has expanded from congenital...

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Published in:	International Breastfeeding Journal
ISSN:	1746-4358
Published:	Springer Science and Business Media LLC 2022
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URI:	https://cronfa.swan.ac.uk/Record/cronfa60890
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first_indexed	2022-08-26T12:01:15Z
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The impact of maternal medicines on children is increasingly recognised as a source of avoidable harm. The focus of attention has expanded from congenital anomalies to include less visible, but equally important, outcomes, including cognition, neurodevelopmental disorders, educational performance, and childhood ill-health. Breastfeeding, whether as a source of medicine exposure, a mitigator of adverse effects or as an outcome, has been all but ignored in pharmacoepidemiology and pharmacovigilance: a significant ‘blind spot’.Whole-population data on breastfeeding: why we need themOptimal child development and maternal health necessitate breastfeeding, yet little information exists to guide families regarding the safety of medicine use during lactation. Breastfeeding initiation or success may be altered by medicine use, and breastfeeding may obscure the true relationship between medicine exposure during pregnancy and developmental outcomes. Absent or poorly standardised recording of breastfeeding in most population databases hampers analysis and understanding of the complex relationships between medicine, pregnancy, breastfeeding and infant and maternal health. The purpose of this paper is to present the arguments for breastfeeding to be included alongside medicine use and neurodevelopmental outcomes in whole-population database investigations of the harms and benefits of medicines during pregnancy, the puerperium and postnatal period. We review: 1) the current situation, 2) how these complexities might be accommodated in pharmacoepidemiological models, using antidepressants and antiepileptics as examples; 3) the challenges in obtaining comprehensive data.ConclusionsThe scarcity of whole-population data and the complexities of the inter-relationships between breastfeeding, medicines, co-exposures and infant outcomes are significant barriers to full characterisation of the benefits and harms of medicines during pregnancy and breastfeeding. This makes it difficult to answer the questions: ‘is it safe to breastfeed whilst taking this medicine’, and ‘will this medicine interfere with breastfeeding and/ or infants’ development’?Keywords: Breastfeeding, Pharmacoepidemiology, Pharmacovigilance, Pregnancy, Child development, Adverse drug reactions</abstract><type>Journal Article</type><journal>International Breastfeeding Journal</journal><volume>17</volume><journalNumber>1</journalNumber><paginationStart/><paginationEnd/><publisher>Springer Science and Business Media LLC</publisher><placeOfPublication/><isbnPrint/><isbnElectronic/><issnPrint/><issnElectronic>1746-4358</issnElectronic><keywords>Breastfeeding; Pharmacoepidemiology; Pharmacovigilance; Pregnancy; Child development; Adverse drug reactions</keywords><publishedDay>2</publishedDay><publishedMonth>8</publishedMonth><publishedYear>2022</publishedYear><publishedDate>2022-08-02</publishedDate><doi>10.1186/s13006-022-00494-5</doi><url/><notes/><college>COLLEGE NANME</college><department>Nursing</department><CollegeCode>COLLEGE CODE</CollegeCode><DepartmentCode>HNU</DepartmentCode><institution>Swansea University</institution><apcterm>Not Required</apcterm><funders>This work has been undertaken under the auspices of the ConcePTION project. The ConcePTION project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 821520. This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA. Funding was awarded to SJ, HD, ML, GJ, RB, CDM. 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spelling	v2 60890 2022-08-26 Breastfeeding, pregnancy, medicines, neurodevelopment, and population databases: the information desert 24ce9db29b4bde1af4e83b388aae0ea1 0000-0002-5691-2987 Sue Jordan Sue Jordan true false ae112e20f29a2a4b0acdfb3abb2ec6a9 0000-0002-3835-8302 Sophia Komninou Sophia Komninou true false 531bc4576ed189dd56a26c36ab401fa5 Naomi Marfell Naomi Marfell true false 2022-08-26 HNU BackgroundThe pharmacoepidemiology of the long-term benefits and harms of medicines in pregnancy and breastfeeding has received little attention. The impact of maternal medicines on children is increasingly recognised as a source of avoidable harm. The focus of attention has expanded from congenital anomalies to include less visible, but equally important, outcomes, including cognition, neurodevelopmental disorders, educational performance, and childhood ill-health. Breastfeeding, whether as a source of medicine exposure, a mitigator of adverse effects or as an outcome, has been all but ignored in pharmacoepidemiology and pharmacovigilance: a significant ‘blind spot’.Whole-population data on breastfeeding: why we need themOptimal child development and maternal health necessitate breastfeeding, yet little information exists to guide families regarding the safety of medicine use during lactation. Breastfeeding initiation or success may be altered by medicine use, and breastfeeding may obscure the true relationship between medicine exposure during pregnancy and developmental outcomes. Absent or poorly standardised recording of breastfeeding in most population databases hampers analysis and understanding of the complex relationships between medicine, pregnancy, breastfeeding and infant and maternal health. The purpose of this paper is to present the arguments for breastfeeding to be included alongside medicine use and neurodevelopmental outcomes in whole-population database investigations of the harms and benefits of medicines during pregnancy, the puerperium and postnatal period. We review: 1) the current situation, 2) how these complexities might be accommodated in pharmacoepidemiological models, using antidepressants and antiepileptics as examples; 3) the challenges in obtaining comprehensive data.ConclusionsThe scarcity of whole-population data and the complexities of the inter-relationships between breastfeeding, medicines, co-exposures and infant outcomes are significant barriers to full characterisation of the benefits and harms of medicines during pregnancy and breastfeeding. This makes it difficult to answer the questions: ‘is it safe to breastfeed whilst taking this medicine’, and ‘will this medicine interfere with breastfeeding and/ or infants’ development’?Keywords: Breastfeeding, Pharmacoepidemiology, Pharmacovigilance, Pregnancy, Child development, Adverse drug reactions Journal Article International Breastfeeding Journal 17 1 Springer Science and Business Media LLC 1746-4358 Breastfeeding; Pharmacoepidemiology; Pharmacovigilance; Pregnancy; Child development; Adverse drug reactions 2 8 2022 2022-08-02 10.1186/s13006-022-00494-5 COLLEGE NANME Nursing COLLEGE CODE HNU Swansea University Not Required This work has been undertaken under the auspices of the ConcePTION project. The ConcePTION project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 821520. This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA. Funding was awarded to SJ, HD, ML, GJ, RB, CDM. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. 2023-06-28T15:58:44.1574182 2022-08-26T12:48:03.7771759 Faculty of Medicine, Health and Life Sciences Swansea University Medical School - Health Data Science Sue Jordan 0000-0002-5691-2987 1 Rebecca Bromley 2 Christine Damase-Michel 3 Joanne Given 4 Sophia Komninou 0000-0002-3835-8302 5 Maria Loane 6 Naomi Marfell 7 Helen Dolk 8 60890__25025__be7a8dd254b241b7b2007e9e13f6700e.pdf 13006_2022_Article_494.pdf 2022-08-26T12:58:26.2507890 Output 2147070 application/pdf Version of Record true © The Author(s) 2022. Open Access This article is licensed under a Creative Commons Attribution 4.0 International License true eng http://creativecommons.org/licenses/by/4.0/
title	Breastfeeding, pregnancy, medicines, neurodevelopment, and population databases: the information desert
spellingShingle	Breastfeeding, pregnancy, medicines, neurodevelopment, and population databases: the information desert Sue Jordan Sophia Komninou Naomi Marfell
title_short	Breastfeeding, pregnancy, medicines, neurodevelopment, and population databases: the information desert
title_full	Breastfeeding, pregnancy, medicines, neurodevelopment, and population databases: the information desert
title_fullStr	Breastfeeding, pregnancy, medicines, neurodevelopment, and population databases: the information desert
title_full_unstemmed	Breastfeeding, pregnancy, medicines, neurodevelopment, and population databases: the information desert
title_sort	Breastfeeding, pregnancy, medicines, neurodevelopment, and population databases: the information desert
author_id_str_mv	24ce9db29b4bde1af4e83b388aae0ea1 ae112e20f29a2a4b0acdfb3abb2ec6a9 531bc4576ed189dd56a26c36ab401fa5
author_id_fullname_str_mv	24ce9db29b4bde1af4e83b388aae0ea1_*_Sue Jordan ae112e20f29a2a4b0acdfb3abb2ec6a9__Sophia Komninou 531bc4576ed189dd56a26c36ab401fa5_**_Naomi Marfell
author	Sue Jordan Sophia Komninou Naomi Marfell
author2	Sue Jordan Rebecca Bromley Christine Damase-Michel Joanne Given Sophia Komninou Maria Loane Naomi Marfell Helen Dolk
format	Journal article
container_title	International Breastfeeding Journal
container_volume	17
container_issue	1
publishDate	2022
institution	Swansea University
issn	1746-4358
doi_str_mv	10.1186/s13006-022-00494-5
publisher	Springer Science and Business Media LLC
college_str	Faculty of Medicine, Health and Life Sciences
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hierarchy_top_title	Faculty of Medicine, Health and Life Sciences
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hierarchy_parent_title	Faculty of Medicine, Health and Life Sciences
department_str	Swansea University Medical School - Health Data Science{{{_:::_}}}Faculty of Medicine, Health and Life Sciences{{{_:::_}}}Swansea University Medical School - Health Data Science
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description	BackgroundThe pharmacoepidemiology of the long-term benefits and harms of medicines in pregnancy and breastfeeding has received little attention. The impact of maternal medicines on children is increasingly recognised as a source of avoidable harm. The focus of attention has expanded from congenital anomalies to include less visible, but equally important, outcomes, including cognition, neurodevelopmental disorders, educational performance, and childhood ill-health. Breastfeeding, whether as a source of medicine exposure, a mitigator of adverse effects or as an outcome, has been all but ignored in pharmacoepidemiology and pharmacovigilance: a significant ‘blind spot’.Whole-population data on breastfeeding: why we need themOptimal child development and maternal health necessitate breastfeeding, yet little information exists to guide families regarding the safety of medicine use during lactation. Breastfeeding initiation or success may be altered by medicine use, and breastfeeding may obscure the true relationship between medicine exposure during pregnancy and developmental outcomes. Absent or poorly standardised recording of breastfeeding in most population databases hampers analysis and understanding of the complex relationships between medicine, pregnancy, breastfeeding and infant and maternal health. The purpose of this paper is to present the arguments for breastfeeding to be included alongside medicine use and neurodevelopmental outcomes in whole-population database investigations of the harms and benefits of medicines during pregnancy, the puerperium and postnatal period. We review: 1) the current situation, 2) how these complexities might be accommodated in pharmacoepidemiological models, using antidepressants and antiepileptics as examples; 3) the challenges in obtaining comprehensive data.ConclusionsThe scarcity of whole-population data and the complexities of the inter-relationships between breastfeeding, medicines, co-exposures and infant outcomes are significant barriers to full characterisation of the benefits and harms of medicines during pregnancy and breastfeeding. This makes it difficult to answer the questions: ‘is it safe to breastfeed whilst taking this medicine’, and ‘will this medicine interfere with breastfeeding and/ or infants’ development’?Keywords: Breastfeeding, Pharmacoepidemiology, Pharmacovigilance, Pregnancy, Child development, Adverse drug reactions
published_date	2022-08-02T15:58:40Z
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Breastfeeding, pregnancy, medicines, neurodevelopment, and population databases: the information desert

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