While maternal health data has long been a pillar of perinatal and pediatric research, the role of paternal health and medication exposure in shaping offspring outcomes has often been overlooked. This gap is largely due to a lack of routine father–child linkage in most healthcare datasets. Yet emerging evidence—particularly for drugs such as antiepileptics (e.g., valproate) and immunosuppressants—suggests paternal exposures may influence both short-term birth outcomes and long-term neurodevelopment.
Research challenge
Regulatory agencies are increasingly requiring safety data that encompasses paternal exposures, but few datasets worldwide can deliver this at scale. Several barriers have limited the feasibility of paternal exposure studies, particularly:
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- Data fragmentation: Fathers are rarely reliably linked to offspring in routine health data, making it difficult to assess paternal drug safety
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- Variable completeness: Even when data exists, missing key identifiers (e.g., date of birth, postcode) limits linkage accuracy
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- Absence of routine genetic confirmation: No guarantee that the man residing in the same household as the child is the biological father, introducing potential misclassification bias in paternal linkage studies
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