POMME: The New Cohort to Evaluate Long-Term Effects After Prenatal Medicine Exposure

• Published in: Drug safety 2019-01, Vol.42 (1), p.45-54
• Main Authors: Benevent, Justine, Hurault-Delarue, Caroline, Araujo, Mélanie, Montastruc, Jean-Louis, Lacroix, Isabelle, Damase-Michel, Christine
• Format: Article
• Language: English
• Subjects: Age; Antidepressants; Autism; Birth; Children; Children & youth; Drug Safety and Pharmacovigilance; Exposure; Health care; Health care policy; Health insurance; Health risk assessment; Long-term effects; Medicine; Medicine & Public Health; Mothers; Original Research Article; Paracetamol; Pharmacology/Toxicology; Population; Pregnancy; Prenatal experience; Prenatal exposure; Prescription drugs; Psychomotor performance; Psychotropic drugs; Respiratory system; Studies; Systematic review; Teenagers; Uterus
• ISSN: 0114-5916; 1179-1942
• DOI: 10.1007/s40264-018-0712-9

Introduction The POMME (PrescriptiOn Médicaments Mères Enfants) cohort has been implemented for the evaluation of the long-term consequences of medicine prenatal exposure. It holds anonymous medical information as well as information on medicine and healthcare reimbursement to the children, from the first day of intra-uterine life until childhood. Objective This article provides a description of the cohort regarding its structure and content and presents an outlook of the studies that could be performed with this new data source. Methods Data sources include (1) the French Health Insurance Database (medicines and medical care prescriptions and reimbursements to children and mothers during pregnancy) and (2) the Mother and Child Protection Centre Database (child health certificates at birth, 9 months of age and 24 months of age). Children born in Haute-Garonne (south-west France), over a period of 1 year (from 1 July to 30 June), are registered in POMME every 5 years. The cohort began on 1 July, 2010. Results To date, 8372 children have been recorded in POMME. They have reached 7 years of age now. Among them, 4249 (50.8%) are boys, 286 (3.4%) were from multiple pregnancies and 519 (6.2%) were born prematurely. They were prenatally exposed to 9.8 ± 6.1 medications. After birth, drug exposure was greatest in children aged 0–2 years. Children were mostly exposed to paracetamol, anti-infective agents and respiratory system drugs; 908 (10.8%) children presented with at least two signs of psychomotor development disorders. Conclusions POMME provides an observatory study on drug exposure and medical care use in children. This innovative cohort would make it possible to assess the risk of the long-term consequences of prenatal medicine exposure.