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

Research output: Contribution to journalArticlepeer-review

Abstract

BACKGROUND: The 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 THEM: Optimal 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.

CONCLUSIONS: The 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'?

Original languageEnglish
Article number55
JournalInternational Breastfeeding Journal
Volume17
Issue number1
Early online date2 Aug 2022
DOIs
Publication statusE-pub ahead of print - 2 Aug 2022

Bibliographical note

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.

Keywords

  • breastfeeding
  • pharmacoepidemiology
  • pharmacovigilance
  • pregnancy
  • child development
  • adverse drug reactions

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