PHARMACOEPIDEMIOLOGY AND PRESCRIPTION Clinical features and risk factors for upper gastrointestinal bleeding in children: a case-crossover study

Objective This population-based survey was conducted to provide a formal description of upper gastrointestinal bleeding (UGIB) in children on a nationwide basis and assess the contribution of risk factors, principally nonsteroidal anti-inflammatory drugs (NSAID). Methods A case-crossover study of UGIB patients aged between 2 months and 16 years was conducted in France. Medical data were collected by physicians, and personal risk factors and exposure to drugs during the month preceding the onset of the bleeding was ascertained by a standardised telephone interview with parents. The odds ratios for UGIB and NSAID was assessed by comparing exposure during the 7 days preceding the date of hospitalisation and the 21st to the 28th days before that date. Results A total of 177 children with UGIB were included over 2 years. Eighty-three children had taken at least one NSAID before the index date, among which 58 were ibuprofen, 26 aspirin and nine others. The adjusted odds ratio (OR) of exposure was 8.2 [95% confidence interval (CI) 2.6– 26.0] for NSAIDs altogether, and this was 10.0 (95% CI 2.0– 51.0) for ibuprofen and 7.3 (95% CI 0.9–59.4) for aspirin. There was no increased risk associated with NSAIDS for oesophageal lesion [OR=1.0 [(5% CI:0.2–7.2)]. Conclusion The study confirms that UGIB is rare but that some cases may be avoided, as one third of the cases was attributable to exposure to NSAID at doses used for analgesic or antipyretic purposes, which may be attained with alternative therapy. The findings from this study call for more caution in prescribing NSAIDS to children. L. Grimaldi-Bensouda : L. Abenhaim Inserm U657 “Pharmacoepidemiology Unit”, Paris, France L. Grimaldi-Bensouda : B. David LA-SER, alpha network, Pepiniere Paris Sante Cochin, 29 rue du Faubourg Saint-Jacques, 75014 Paris, France L. Abenhaim London School of Hygiene and Tropical Medicine, London, UK L. Michaud Department of Paediatric Gastroenterology, Jeanne de Flandre Hospital, France, Avenue Eugène Avinée, 59037 Lille Cedex, France O. Mouterde Department of Paediatrics, Rouen University Hospital, France, 1 rue de Germont, 76031 Rouen Cedex, France A. P. Jonville-Béra : E. Autret-Leca Department of Pharmacology, Tours University Hospital, France, 2 boulevard Tonnellé, 37044 Tours cedex 9, France B. Giraudeau Inserm CIC 202, France; François Rabelais University Tours, France; Tours University Hospital, France, 2 bis boulevard Tonnellé, 37032 Tours cedex 1, France E. Autret-Leca Department of Pharmacology, François Rabelais University Tours, Tours, France E. Autret-Leca (*) Service de Pharmacologie Clinique CHRU de Tours, 2 boulevard Tonnelle, 37044 Tours cedex 9, France e-mail: [email protected] Eur J Clin Pharmacol DOI 10.1007/s00228-010-0832-3