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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
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.
Objective:
To analyse serious upper gastrointestinal (UGI) complications associated with non-salicylate non-steroidal anti-inflammatory drugs (NSAIDs) in children.
Methods:
All serious UGI complications associated with non-salicylate NSAIDs approved in France to treat moderate pain or fever in children, spontaneously reported to the French Pharmacovigilance system or to the companies, between the launching of each study drug in France to December 31, 2000.
Results:
Serious UGI complications were reported in 61 children aged from 11 months to 15 years during treatment with niflumic acid (27), ibuprofen (23) and tiaprofenic acid (11). No case was reported with ketoprofen. UGI manifestations were UGI bleeding (15) and 46 gastrointestinal symptoms with endoscopic lesions i.e. gastritis (18), gastric ulcer (13), duodenal ulcer (7), duodenitis (4) and oesophageal ulcer (4). NSAID was combined with a salicylate in 36% of cases, given by the parents in self medication in 6.6% of cases and used outside its product licence in 33.8% of cases.
Conclusion:
NSAIDs used in children for fever or moderate pain are associated with a risk of serious UGI complications which increases with length, dose and association with a salicylate.
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