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Thematic File: Pregnancy and Children

EPI-PHARE’s Work on Pregnancy, Newborns, and Children

The use and safety of medications in pregnant women and children is a priority area for EPI-PHARE. Given the size of these populations, their high medication use, their particular vulnerability to adverse drug reactions, and their insufficient representation in drug safety assessments based on clinical trials, this is a major public health issue.

 

For this thematic, EPI-PHARE uses the EPI-MERES registry, whose data are continuously updated, allowing for the annual addition of new pregnancies and the extension of follow-up for the children, and which benefits from the development of new tools designed in particular to identify the children’s fathers and siblings and to improve the detection of certain conditions such as major congenital malformations and neurodevelopmental disorders.

 

EPI–PHARE has already conducted several studies critical for decision–making, for example regarding the use and safety of medications frequently taken by pregnant women (medications for epilepsy, chronic inflammatory bowel disease (IBD), or multiple sclerosis, and antibiotics), as well as on the risk of serious infection associated with the use of proton pump inhibitors in infants.

 

To conduct pharmacoepidemiological studies in pregnant women, newborns, and children, EPI-PHARE developed the National Mother-Child Registry (EPI-MERES) using data from the French National Health Data System (SNDS).

 

This internal database records all pregnancies that have occurred in France since 2010 and allows for linkage with the children born from those pregnancies, making it possible to track their development and health status from birth. EPI–MERES, which currently includes more than 14 million pregnancies and 10.7 million children (98% of births recorded by INSEE) followed up to 15 years after birth, is an indispensable tool for research in perinatal pharmacoepidemiology and ranks among the most promising in the world due to its size and the wealth of information it contains.

 

The EPI–MERES registry enables the identification of indicators of drug toxicity in children:

  • major congenital malformations (MCM), for which the prevalence rates observed in EPI-MERES are close to those reported by EUROCAT (an overall difference of only -1%), confirming the reliability of the SNDS in identifying them;
  • neurodevelopmental disorders (NDD);
  • fetotoxicity, serious infections, cancer…

 

It also facilitates the development of automated tools for measuring drug exposure during pregnancy and identifying teratogenic drugs. Recent advances have also made it possible to link children to their fathers and identify sibling groups, opening up new avenues of research into the impact of drugs on reproduction and child development.

 

You will find below all the references of peer-reviewed articles published by EPI-PHARE on this topic.

Use of Medications during Pregnancy and in Children
  1.  Lassalle, M., Sebban, S., Talbotec, C., & Spira, R. D.-. (2026). Use of proton pump inhibitors in infants : Nationwide Cohort Study Based on the French EPI-MERES Register. The Journal of Pediatrics: Clinical Practice, 200214. [lien]
  2. Shahriari, P., Drouin, J., Miranda, S., Bougas, N., Botton, J., & Dray-Spira, R. (2025). Trends in Prenatal Exposure to Antiseizure Medications Over the Past Decade. Neurology, 105(4), e213933. [link]
  3. Boutin, S., Bertrand, M., Cohen, J. F., Zureik, M., Chalumeau, M., & Jabagi, M.-J. (2025). Sociodemographic Characteristics of Infants Receiving Nirsevimab. JAMA Network Open, 8(4), e254341. [link]
  4. Swital, M., Drouin, J., Miranda, S., Bakchine, S., Botton, J., & Dray-Spira, R. (2024). Use of multiple sclerosis disease-modifying therapies during pregnancy in France : Nationwide study between 2010 and 2021. Multiple Sclerosis Journal, 13524585231223395. [link]
  5. Tubiana, S., Sibiude, J., Herlemont, P., Drouin, J., Picone, O., Duval, X., Weill, A., Zureik, M., & Dray-Spira, R. (2023). Trends in anti-infective use during pregnancy in France between 2010 and 2019 : A nationwide population-based study. British Journal of Clinical Pharmacology, 89(5), 1629‑1639. [link]
  6. Tran, A., Zureik, M., Sibiude, J., Drouin, J., Miranda, S., Weill, A., Dray-Spira, R., Duval, X., & Tubiana, S. (2023). Prevalence and associated factors of antibiotic exposure during pregnancy in a large French population-based study during the 2010–19 period. Journal of Antimicrobial Chemotherapy, 78(10), 2535‑2543. [link]
  7. Taine, M., Offredo, L., Weill, A., Dray-Spira, R., Zureik, M., & Chalumeau, M. (2022). Pediatric Outpatient Prescriptions in Countries With Advanced Economies in the 21st Century : A Systematic Review. JAMA Network Open, 5(4), e225964. [link]
  8. Plueschke, K., Flynn, R., Hedenmalm, K., Deli, A.-C., Maciá-Martinez, M.-A., García-Poza, P., Olsen, D., Nguyen, P., & Quinten, C. (2022). Prescribing Patterns of Codeine and Alternative Medicines in Children in Europe. Drug Safety, 45, 1069‑1081. [link]
  9. Taine, M. et al. (2021) ‘Mandatory Infant Vaccinations in France During the COVID-19 Pandemic in 2020’, Frontiers in Pediatrics, 9. [link]
  10. Taine, M., Offredo, L., Dray-Spira, R., Weill, A., Chalumeau, M., & Zureik, M. (2021). Paediatric outpatient prescriptions in France between 2010 and 2019 : A nationwide population-based study: Paediatric outpatient prescriptions in France, 2010 to 2019. The Lancet Regional Health – Europe, 7, 100129. [link]
  11. Meyer, A., Fermaut, M., Drouin, J., Carbonnel, F., & Weill, A. (2021). Drug use for gastrointestinal symptoms during pregnancy : A French nationwide study 2010–2018. PLOS ONE, 16(1), e0245854. [link]
  12. Blotière, P.-O., Damase-Michel, C., Weill, A., & Maura, G. (2021). Dispensing of Potentially Harmful Prescription Drugs in 1.8 Million Pregnant Women in France : A Nationwide Study Based on Two Risk Classification Systems. Drug Safety, 44(12), 1323‑1339. [link]
Efficacy and Risks of Medications During Pregnancy and in Children
  • Gabet, A., Bertrand, M., Jabagi, M.-J., Kolla, E., Olié, V., & Zureik, M. (2025). Maternal and Neonatal Outcomes After Respiratory Syncytial Virus Prefusion F Protein Vaccination During Pregnancy : Analysis From the 2024–2025 Immunization Campaign in France. Obstetrics & Gynecology, 10.1097/AOG.0000000000006121. [link]
  • Jabagi, M. J., Cohen, J., Bertrand, M., Chalumeau, M., & Zureik, M. (2025). Nirsevimab Effectiveness at Preventing RSV-Related Hospitalization in Infants. NEJM Evidence, 4(3), EVIDoa2400275. [link]
  • Jabagi, M.-J., Bertrand, M., Gabet, A., Kolla, E., Olié, V., & Zureik, M. (2025). Nirsevimab vs RSVpreF Vaccine for Respiratory Syncytial Virus–Related Hospitalization in Newborns. JAMA. [link]
  • Vegas, L. P., Drouin, J., Weill, A., & Dray-Spira, R. (2024). Pregnancy outcomes in women with rheumatoid arthritis : An 11-year French nationwide study. RMD Open, 10(1), e003762. [link]
  • Meyer, A., Miranda, S., Drouin, J., Weill, A., Carbonnel, F., & Dray-Spira, R. (2024). Safety of vedolizumab and ustekinumab compared with anti-TNF in pregnant women with inflammatory bowel disease. Clinical Gastroenterology and Hepatology. [link]
  • Lassalle, M., Zureik, M., & Dray-Spira, R. (2023). Proton Pump Inhibitor Use and Risk of Serious Infections in Young Children. JAMA Pediatrics, 177(10), 1028‑1038. [link]
  • Meyer, A., Rios, P., Drouin, J., Weill, A., Carbonnel, F., & Dray-Spira, R. (2023). Maternal exposure to anti-TNF or thiopurines for IBD does not increase risk of early-life malignancy in children. Clinical Gastroenterology and Hepatology, 21(10), 2679‑2681. [link]
  • Meyer, A., Neumann, A., Drouin, J., Weill, A., Carbonnel, F., & Dray-Spira, R. (2022). Benefits and Risks Associated With Continuation of Anti–Tumor Necrosis Factor After 24 Weeks of Pregnancy in Women With Inflammatory Bowel Disease : A Nationwide Emulation Trial. Annals of Internal Medicine, 175(10), 1374‑1382. (world). [link]
  • Meyer, A., Taine, M., Drouin, J., Weill, A., Carbonnel, F., & Dray-Spira, R. (2022). Serious Infections in Children Born to Mothers With Inflammatory Bowel Disease With In Utero Exposure to Thiopurines and Anti-Tumor Necrosis Factor. Clinical Gastroenterology and Hepatology, 20(6), 1269-1281.e9. [link]
  • Meyer, A., Drouin, J., Weill, A., Carbonnel, F., & Dray-Spira, R. (2021). Comparative study of pregnancy outcomes in women with inflammatory bowel disease treated with thiopurines and/or anti-TNF : A French nationwide study 2010–2018. Alimentary Pharmacology & Therapeutics, 54(3), 302‑311. [link]
  • Meyer, A., Drouin, J., Weill, A., Carbonnel, F., & Dray‐Spira, R. (2020). Pregnancy in women with inflammatory bowel disease : A French nationwide study 2010-2018. Alimentary Pharmacology & Therapeutics, 52(9), 1480‑1490. [link]
Focus on Major Congenital Malformations (MCMs)
  •  Duchemin, T., Marty, L., Drouin, J., Miranda, S., Botton, J., Olié, V., Weill, A., & Dray-Spira, R. (2026). Identification of major congenital malformations based on healthcare databases in France : A proof-of-concept study using the epi-meres nationwide mother–child register. British Journal of Clinical Pharmacology. [link]
  • Shahriari, P., Drouin, J., Miranda, S., Bougas, N., Botton, J., & Dray-Spira, R. (2025). Trends in Prenatal Exposure to Antiseizure Medications Over the Past Decade. Neurology, 105(4), e213933. [link]
  • Tran, A., Zureik, M., Sibiude, J., Miranda, S., Drouin, J., Marty, L., Weill, A., Dray-Spira, R., Duval, X., & Tubiana, S. (2025). First-trimester exposure to macrolides and risk of major congenital malformations compared with amoxicillin : A French nationwide cohort study. PLOS Medicine, 22(4), e1004576. [link]
  • Bernard, C., Duchemin, T., Marty, L., Drouin, J., Miranda, S., Semenzato, L., Botton, J., Chouchana, L., Dray-Spira, R., Weill, A., & Zureik, M. (2025). First-Trimester mRNA COVID-19 Vaccination and Risk of Major Congenital Anomalies. JAMA Network Open, 8(10), e2538039. [link]
  • Meyer, A., Marty, L., Drouin, J., Weill, A., Carbonnel, F., & Dray-Spira, R. (2025). Risks of 75 major congenital malformations after in utero exposure to thiopurines and anti-TNF for maternal inflammatory bowel disease. Clinical Gastroenterology and Hepatology, 0(0). [link]
  • Rios, P., Herlemont, P., Fauque, P., Lacour, B., Jouannet, P., Weill, A., Zureik, M., Clavel, J., & Dray-Spira, R. (2024). Medically Assisted Reproduction and Risk of Cancer Among Offspring. JAMA Network Open, 7(5), e249429. [link]
  • Coste, J., Blotiere, P.-O., Miranda, S., Mikaeloff, Y., Peyre, H., Ramus, F., Zureik, M., Weill, A., & Dray-Spira, R. (2020). Risk of early neurodevelopmental disorders associated with in utero exposure to valproate and other antiepileptic drugs : A nationwide cohort study in France. Scientific Reports, 10(1), Article 1. [link]
  • Blotiere, P.-O., Raguideau, F., Weill, A., Elefant, E., Perthus, I., Goulet, V., Rouget, F., Zureik, M., Coste, J., & Dray-Spira, R. (2019). Risks of 23 specific malformations associated with prenatal exposure to 10 antiepileptic drugs. Neurology, 93(2), e167‑e180. [link]
Focus on Neurodevelopmental Disorders (NDDs)
  • Peyre, H., Rios, P., Botton, J., Herlemont, P., Olié, V., Miranda, S., Zureik, M., Weill, A., & Dray-Spira, R. (2026). Shared and disorder-specific prenatal and perinatal risk factors for neurodevelopmental disorders : A nationwide cohort study. Molecular Psychiatry, 1‑10. [link]
  • Blotière, P.-O., Miranda, S., Weill, A., Mikaeloff, Y., Peyre, H., Ramus, F., Mahmoud, Z., Coste, J., & Dray-Spira, R. (2020). Risk of early neurodevelopmental outcomes associated with prenatal exposure to the antiepileptic drugs most commonly used during pregnancy : A French nationwide population-based cohort study. BMJ Open, 10(6), e034829. [link]
  • Coste, J., Blotiere, P.-O., Miranda, S., Mikaeloff, Y., Peyre, H., Ramus, F., Zureik, M., Weill, A., & Dray-Spira, R. (2020). Risk of early neurodevelopmental disorders associated with in utero exposure to valproate and other antiepileptic drugs : A nationwide cohort study in France. Scientific Reports, 10(1), Article 1. [link]