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Breastfeeding, pregnancy, medicines, neurodevelopment, and population databases: the information desert
Sue Jordan1, Rebecca Bromley2,3, Christine Damase-Michel4
1Faculty of Medicine, Health and Life Science, Swansea University, Swansea, Wales, UK. s.e.jordan@swansea.ac.uk.
Insights
Pharmacoepidemiology research needs to include breastfeeding to understand medicine safety for mothers and children. Including breastfeeding data is crucial for assessing long-term benefits and harms of medications.
Area of Science:
- Pharmacoepidemiology
- Maternal and Child Health
- Pharmacovigilance
Background:
- Long-term benefits and harms of medications during pregnancy and breastfeeding are understudied.
- Maternal medication use can cause avoidable harm to children, impacting cognition, neurodevelopment, and health.
- Breastfeeding's role in medicine exposure, mitigation, and outcomes is largely ignored in pharmacoepidemiology.
Purpose of the Study:
- Advocate for incorporating breastfeeding into whole-population database investigations.
- To address the lack of information guiding safe medicine use during lactation.
- To analyze the complex relationships between medicines, pregnancy, breastfeeding, and infant/maternal health.
Main Methods:
- Reviewing the current situation of data collection and research.
- Proposing methods to model complexities of breastfeeding in pharmacoepidemiological studies, using antidepressants and antiepileptics as examples.
- Identifying challenges in obtaining comprehensive data on breastfeeding and medication use.
Main Results:
- Significant data scarcity and methodological complexities hinder the characterization of medication benefits and harms.
- Current population databases lack standardized recording of breastfeeding, impeding analysis.
- Existing models struggle to account for the interplay of medicines, pregnancy, and breastfeeding.
Conclusions:
- Whole-population data on breastfeeding is essential for understanding medication safety.
- Addressing this 'blind spot' is critical for answering key questions about medication safety during lactation.
- Improved data collection and modeling are needed to fully assess medication risks and benefits for breastfeeding mothers and infants.
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'?
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