Abstract
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’?
Funder
Innovative Medicines Initiative
Publisher
Springer Science and Business Media LLC
Subject
Obstetrics and Gynecology,Pediatrics, Perinatology and Child Health
Reference158 articles.
1. EMA. Guideline on good pharmacovigilance practices (GVP) 3 Product- or Population-Specific Considerations III: Pregnant and 4 breastfeeding women. EMA/653036/2019 DRAFT FOR PUBLIC CONSULTATION EMA, Heads of Medicines agencies 4.12.19, Amsterdam. Available: https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-good-pharmacovigilance-practices-product-population-specific-considerations-iii_en.pdf. Accessed 2 Nov 2020.
2. Damase-Michel C, Wurst K, et al . Core evidence elements for generating medication safety evidence for pregnancy using population-based data Core data elements, design and analytical foundations ConcePTION-D1.2.pdf (imi-conception.eu). 2021. available: https://www.imi-conception.eu/news-details/?news_id=693].
3. European Medicines Agency (EMA). Guideline on good pharmacovigilance (GVP) . Module vi – collection, management and submission of reports of suspected adverse reactions to medicinal products. rev 2. 2017.
4. Sackett D. Bias in analytic research. J Chronic Dis. 1979;32(1–2):51–63.
5. Munafo MR, Tilling K, Taylor AE, Evans DM, Davey Smith G. Collider scope: When selection bias can substantially influence observed associations. Int J Epidemiol. 2018;47(1):226–35.
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