A new tool to study the effects of in utero medication exposure on neurodevelopment in children.

Researchers in France created a new database to study how medications taken during pregnancy might affect children's brain development. They looked at nearly 100,000 children and found that those with autism or severe disabilities were more likely to have been exposed to certain medications (especially brain/nervous system drugs) before birth. This new tool will help scientists better understand medication safety during pregnancy.

French researchers developed a new database tool linking medication prescription data with childhood disability registries to study in utero drug exposure effects on neurodevelopment. The EFEMERIS database was matched with the Haute-Garonne disability registry, identifying 908 children with autism spectrum disorder and/or severe disabilities from 97,350 births between 2004-2014. Children with ASD/severe disabilities showed significantly higher exposure to certain medication classes, particularly nervous system drugs, during pregnancy. This represents the first pharmacoepidemiologic tool of its kind in France for investigating relationships between prenatal medication exposure and neurodevelopmental outcomes in children.

Establishes infrastructure for future research into prenatal medication safety and neurodevelopmental outcomes. The database will enable investigation of specific medication risks during pregnancy, potentially informing clinical decision-making for pregnant women requiring medication treatment.

This is a database development study rather than an analytical investigation. No specific medication exposure rates, statistical measures, or causal relationships are reported. The study describes methodology but does not present detailed pharmacoepidemiologic findings.

Here we describe the implementation of a new tool that would allow to assess the risk of serious disability following in utero exposure to medications. The overall objective was to enrich the EFEMERIS database [Évaluation chez la Femme Enceinte des MEdicaments et de leurs RISques (evaluation in the pregnant woman of medications and their risques database] containing data on reimbursed medication prescriptions and pregnancy outcomes) with data from the Haute-Garonne childhood disability registry (RHE31). The EFEMERIS database included 97,350 children born between 2004 and 2014 who were still living in Haute-Garonne at the age of 8. After matching with the RHE31, we identified 908 children (58.8% of RHE31-eligible children) with pervasive developmental disorder (PDD)/autism spectrum disorder (ASD) and/or severe motor impairment, severe neurosensory impairment or intellectual disability (IQ<50).

Non-matched RHE31-eligible children did not differ significantly from matched children. Children diagnosed with PDD/ASD and/or severe disability were significantly more likely to have been exposed to certain ATC drug classes, particularly those in the "nervous system" class. Given the number of RHE31-children included, we can already envisage pharmacoepidemiologic studies to investigate the relationship between in utero medication exposure and the child's risk of neurodevelopmental disorders. This project, the first of its kind in France, will specifically improve data on the effects of medications on child neurodevelopment.