Is Racecadotril (acetorphan) safe for use in toddlers?

Safety of Racecadotril in Toddlers

Racecadotril is generally safe for use in toddlers with acute diarrhea as an adjunct to oral rehydration therapy, but it should not be considered first-line treatment. 1

Safety Profile and Evidence

Racecadotril has been studied in children as young as 3 months of age with generally favorable safety outcomes:

• Multiple randomized controlled trials have shown that racecadotril is well tolerated in young children with few adverse events 2, 3
• A meta-analysis of five studies with 949 participants showed no significant difference in adverse events between racecadotril and placebo (risk ratio 0.99,95% CI 0.73 to 1.34) 4
• Most adverse events reported in clinical trials were mild and transient 2

Efficacy in Children

While safety is established, efficacy data shows:

• Racecadotril can reduce stool output by up to 50% compared to placebo 3
• Treatment with racecadotril has been shown to significantly reduce the duration of diarrhea (28 hours vs. 72 hours in rotavirus-positive patients) 2
• A meta-analysis showed significantly shorter duration of symptoms with racecadotril compared with placebo (mean difference -53.48 hours) 4

Important Considerations and Limitations

Despite these positive findings, several important caveats must be considered:

• The American Academy of Pediatrics and the Infectious Diseases Society of America recommend oral rehydration solution (ORS) as first-line therapy for mild to moderate dehydration in infants 1
• A recent Cochrane review concluded that "racecadotril seems to be a safe drug but has little benefit in improving acute diarrhea in children under five years of age" 5
• The overall quality of evidence supporting racecadotril is limited due to sparse data, heterogeneity, and risk of bias in available studies 4

Recommended Approach

For managing diarrhea in toddlers:

1. First-line treatment: Oral rehydration solution (ORS) for mild to moderate dehydration 1
2. Nutritional support: Continue human milk feeding throughout the diarrheal episode 1
3. Diet: Resume age-appropriate diet during or immediately after rehydration 1
4. Consider racecadotril as adjunctive therapy: May be added to ORS if diarrhea is severe or persistent, at a dose of 1.5 mg/kg administered orally 3 times daily 3, 2
5. Monitor closely: Watch for any adverse effects, though they are generally mild and transient

Conclusion

While racecadotril appears to be safe in toddlers based on available evidence, it should be used as an adjunct to oral rehydration therapy rather than as a primary treatment. The focus of management should remain on appropriate rehydration and nutritional support.