What are the statistics of gastrointestinal (GI) bleeding with Neurofen (ibuprofen) use in the pediatric age group?

Statistics of GI Bleeding with Ibuprofen (Neurofen) Use in Pediatric Age Group

The risk of gastrointestinal bleeding with ibuprofen use in children is low, with reported rates of 7.2 to 17 per 100,000 children, but this risk is still higher than with acetaminophen. 1, 2

Risk Factors and Incidence

Incidence Data

• The risk of hospitalization for GI bleeding among children receiving ibuprofen is approximately:
  • 17 per 100,000 children under 2 years old 1
  • 7.2 per 100,000 children in a broader pediatric population 2

Comparative Risk

• In a large randomized clinical trial with 84,192 children, only 4 cases of acute non-major GI bleeding occurred in ibuprofen-treated children 2
• A case-crossover study found that ibuprofen increased the risk of upper GI bleeding with an adjusted odds ratio of 10.0 (95% CI 2.0-51.0) compared to no NSAID use 3
• One-third of pediatric upper GI bleeding cases may be attributable to NSAID exposure 3

Risk Factors That Increase GI Bleeding Risk

• Increasing age 4
• Previous gastrointestinal events 4
• Concomitant use of:
  • Anticoagulation therapy 4
  • Corticosteroids (approximately doubles the risk) 4
• Inappropriate medication use (found in 47% of pediatric GI bleeding cases) 5
• Helicobacter pylori infection (found in 19.6% of children with NSAID-related GI bleeding) 5

Clinical Presentation and Findings

When GI bleeding occurs in children taking ibuprofen, the most common presentations include:

• Hematemesis (33.3% of cases) 5
• Endoscopic findings:
  • Gastric lesions (62% of cases)
  • Duodenal lesions (33% of cases)
  • Esophageal lesions (15% of cases) 5

Management Considerations

Treatment Outcomes

• In an Italian survey, 94% of pediatric patients with NSAID-related GI bleeding responded to medical therapy with spontaneous resolution 5
• Only 6% required endoscopic hemostasis 5

Prevention Strategies

• Use the lowest effective dose for the shortest duration 4
• Consider alternative antipyretics/analgesics in high-risk children 3
• Avoid combining NSAIDs with other medications that increase bleeding risk 4

Important Clinical Caveats

1. Short-term vs. Long-term Use: Most safety data focuses on short-term use; there is limited information on the safety of prolonged ibuprofen use in children 1, 2

2. Dose-Response Relationship: There appears to be a general dose-response relationship for GI bleeding risk, though not always statistically significant 6

3. Specific Lesion Types: NSAIDs appear to have different risks based on lesion location - the risk is higher for gastric/duodenal lesions than for esophageal lesions 3

4. Prescription vs. OTC Use: The incidence of GI bleeding-related hospitalization is <0.2% for patients on OTC-comparable doses of ibuprofen 6

While the absolute risk of serious GI bleeding with ibuprofen use in children is low, clinicians should be aware of this potential adverse effect, especially in children with risk factors, and consider the risk-benefit ratio when prescribing NSAIDs to pediatric patients.