Arch Dis Child doi:10.1136/archdischild-2012-302100
  • Original article

Drug use and upper gastrointestinal complications in children: a case–control study

Open Access
  1. and the Italian Multicenter Study Group for Drug and Vaccine Safety in Children
  1. 1Regina Margherita Children's Hospital, Turin, Italy
  2. 2Anna Meyer Children's University Hospital, Florence, Italy
  3. 3Santobono Paediatric Hospital, Naples, Italy
  4. 4National Centre for Epidemiology, Italian National Institute of Health, Rome, Italy
  1. Correspondence to Dr Francesca Menniti-Ippolito, National Centre for Epidemiology, National Institute of Health, Viale Regina Elena 299, Rome 00161, Italy; francesca.menniti{at}
  • Received 26 March 2012
  • Revised 25 October 2012
  • Accepted 26 October 2012
  • Published Online First 21 December 2012


Objective To evaluate the risk of upper gastrointestinal complications (UGIC) associated with drug use in the paediatric population.

Methods This study is part of a large Italian prospective multicentre study. The study population included children hospitalised for acute conditions through the emergency departments of eight clinical centres. Patients admitted for UGIC (defined as endoscopically confirmed gastroduodenal lesions or clinically defined haematemesis or melena) comprised the case series; children hospitalised for neurological disorders formed the control group. Information on drug and vaccine exposure was collected through parental interview during the children's hospitalisation. Logistic regression was used to estimate ORs for the occurrence of UGIC associated with drug use adjusted for age, clinical centre and concomitant use of any drug.

Results 486 children hospitalised for UGIC and 1930 for neurological disorders were enrolled between November 1999 and November 2010. Drug use was higher in cases than in controls (73% vs 54%; p<0.001). UGICs were associated with the use of non-steroidal anti-inflammatory drugs (NSAIDs) (adjusted OR 2.9, 95% CI 2.1 to 4.0), oral steroids (adjusted OR 2.9, 95% CI 1.7 to 4.8) and antibiotics (adjusted OR 2.3, 95% CI 1.8 to 3.1). The duration of use of these drug categories was short (range 1–8 days). Paracetamol showed a lower risk (adjusted OR 2.0, 95% CI 1.5 to 2.6) compared to ibuprofen (adjusted OR 3.7, 95% CI 2.3 to 5.9), although with partially overlapping CIs.

Conclusions NSAIDs, oral steroids and antibiotics, even when administered for a short period, were associated with an increased risk of UGIC.

This is an open-access article distributed under the terms of the Creative Commons Attribution Non-commercial License, which permits use, distribution, and reproduction in any medium, provided the original work is properly cited, the use is non commercial and is otherwise in compliance with the license. See: and

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