Adverse Events Associated with Over-the-counter Antidiarrheals in Children: An Observational Real-world FAERS-based...

Area of Science:

• Pediatric Pharmacology
• Drug Safety and Pharmacovigilance
• Gastroenterology

Background:

• Over-the-counter (OTC) antidiarrheals are frequently used for pediatric diarrhea management.
• Potential risks associated with OTC antidiarrheal use in children are not fully understood.
• The FDA Adverse Event Reporting System (FAERS) database is a valuable resource for identifying drug safety signals.

Purpose of the Study:

• To assess suspected adverse events linked to common OTC antidiarrheals in children (<16 years).
• To identify potential safety signals using disproportionality analysis in FAERS data.
• To inform healthcare providers and caregivers about the risks of pediatric antidiarrheal use.

Main Methods:

• Disproportionality analysis of FAERS spontaneous reports (March 2004 - June 2024).
• Inclusion of pediatric cases (<16 years) for bismuth subsalicylate, diphenoxylate, atropine/diphenoxylate, kaolin, pectin, and loperamide.
• Application of frequentist and Bayesian signal detection criteria to identify safety signals.

Main Results:

• Loperamide had the highest report count (n=256/311).
• Key safety signals included cardiac conduction abnormalities, lethargy, paralytic ileus, and fatalities with loperamide.
• Diphenoxylate and atropine/diphenoxylate showed significantly higher mortality rates compared to loperamide and bismuth subsalicylate (p=0.00001).

Conclusions:

• Significant risks are associated with OTC antidiarrheal use in the pediatric population.
• Healthcare providers and caregivers should exercise caution and recommend judicious use.
• Continued pharmacovigilance is crucial for ensuring the safety of pediatric patients using antidiarrheals.