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

BACKGROUND: Over-the-counter (OTC) antidiarrheal medications are commonly used despite potential risks for diarrheal management in children. We aimed to assess the reported suspected adverse events associated with OTC antidiarrheals from the FDA Adverse Event Reporting System (FAERS).

METHODS: We conducted a disproportionality analysis of suspected adverse event reports pertaining to commonly used antidiarrheals in the pediatric age group (aged < 16 years) as follows: bismuth subsalicylate, diphenoxylate, atropine/diphenoxylate, kaolin, pectin, and loperamide. Spontaneous reports from the FAERS database between March 2004 and June 2024 were obtained and analyzed using frequentist and Bayesian signal detection criteria to identify potential safety signals.

RESULTS AND DISCUSSION: Loperamide accounted for the highest number of reports (n=256) of the total 311. Cardiac conduction abnormalities, lethargy, paralytic ileus, and fatalities with loperamide, and central nervous system adverse events with diphenoxylate and atropine/diphenoxylate were the key safety signals identified. Significantly higher mortality rates were observed with diphenoxylate and atropine/diphenoxylate compared to loperamide and bismuth subsalicylate (p = 0.00001). These findings are broadly consistent with existing clinical and regulatory literature and support existing recommendations cautioning against the routine use of certain antidiarrheal agents in young children.

CONCLUSION: We identified significant risks associated with OTC antidiarrheal use in children. This emphasizes the need for caution among healthcare providers and caregivers. Judicious use is recommended in the pediatric age group, considering the potential severity of these adverse events. Continued pharmacovigilance is essential to ensure the safety of pediatric patients.