{"title":"A new tool to study the effects of in utero medication exposure on neurodevelopment in children.","authors":"Laurane Delteil, Caroline Hurault-Delarue, Catherine Arnaud, Dana Klapouszczak, Isabelle Lacroix, Malika Delobel-Ayoub","doi":"10.1016/j.therap.2025.06.009","DOIUrl":null,"url":null,"abstract":"<p><p>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.</p>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":" ","pages":""},"PeriodicalIF":1.8000,"publicationDate":"2025-07-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Therapie","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1016/j.therap.2025.06.009","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"PHARMACOLOGY & PHARMACY","Score":null,"Total":0}
引用次数: 0
Abstract
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.
在这里,我们描述了一种新工具的实施,该工具可以评估子宫内暴露于药物后严重残疾的风险。总体目标是用Haute-Garonne儿童残疾登记(RHE31)的数据丰富EFEMERIS数据库[Évaluation chez la Femme Enceinte des medicents et de leurs RISques(孕妇药物评估及其风险数据库),该数据库包含报销药物处方和妊娠结局的数据。EFEMERIS数据库包括2004年至2014年间出生的97,350名8岁时仍生活在上加隆的儿童。在与RHE31匹配后,我们确定了908名儿童(占符合RHE31条件的儿童的58.8%)患有广泛性发育障碍(PDD)/自闭症谱系障碍(ASD)和/或严重运动障碍、严重神经感觉障碍或智力残疾(IQ)
期刊介绍:
Thérapie is a peer-reviewed journal devoted to Clinical Pharmacology, Therapeutics, Pharmacokinetics, Pharmacovigilance, Addictovigilance, Social Pharmacology, Pharmacoepidemiology, Pharmacoeconomics and Evidence-Based-Medicine. Thérapie publishes in French or in English original articles, general reviews, letters to the editor reporting original findings, correspondence relating to articles or letters published in the Journal, short articles, editorials on up-to-date topics, Pharmacovigilance or Addictovigilance reports that follow the French "guidelines" concerning good practice in pharmacovigilance publications. The journal also publishes thematic issues on topical subject.
The journal is indexed in the main international data bases and notably in: Biosis Previews/Biological Abstracts, Embase/Excerpta Medica, Medline/Index Medicus, Science Citation Index.