Upper gastrointestinal complications associated with NSAIDs in children

Elisabeth Autret-Leca1, Lamiae Bensouda-Grimaldi, Chantal Maurage

  • 1CHRU of Tours, Regional Centre of Pharmacovigilance, Department of Pharmacology, Hôpital Bretonneau, 2 boulevard Tonnellé, 37044 Tours Cedex 9, France. autret-leca@med.univ.tours.fr

Therapie
|June 22, 2007
PubMed

Insights

Non-salicylate non-steroidal anti-inflammatory drugs (NSAIDs) can cause serious upper gastrointestinal complications in children. Risk increases with NSAID duration, dosage, and concurrent salicylate use.

Area of Science:

  • Pediatric pharmacology
  • Gastroenterology
  • Drug safety

Background:

  • Non-steroidal anti-inflammatory drugs (NSAIDs) are commonly prescribed for pain and fever in children.
  • Concerns exist regarding the gastrointestinal safety of NSAIDs in pediatric populations.
  • Specific data on serious upper gastrointestinal (UGI) complications from non-salicylate NSAIDs in children are limited.

Purpose of the Study:

  • To analyze serious upper gastrointestinal (UGI) complications associated with non-salicylate NSAIDs in children.
  • To identify specific NSAIDs linked to UGI issues in pediatric patients.
  • To understand factors influencing the risk of UGI complications.

Main Methods:

  • Retrospective analysis of spontaneously reported adverse events to the French Pharmacovigilance system and pharmaceutical companies.
  • Inclusion of data from drug launch in France until December 31, 2000.
  • Focus on non-salicylate NSAIDs approved for moderate pain or fever in children.

Main Results:

  • Sixty-one serious UGI complications were reported in children aged 11 months to 15 years.
  • Niflumic acid, ibuprofen, and tiaprofenic acid were associated with UGI complications; ketoprofen was not.
  • Complications included UGI bleeding and various endoscopic lesions like gastritis and ulcers. Concurrent salicylate use, self-medication, and off-label use were noted.

Conclusions:

  • Non-salicylate NSAIDs used for pediatric fever or pain carry a risk of serious UGI complications.
  • The risk is dose-dependent and increases with the duration of NSAID treatment.
  • Concomitant use of NSAIDs with salicylates significantly elevates the risk of UGI complications in children.
Abstract

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