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Adverse Events Associated with Over-the-counter Antidiarrheals in Children: An Observational Real-world FAERS-based
Kannan Sridharan1, Gowri Sivaramakrishnan2
1Department of Pharmacology & Therapeutics, College of Medicine & Health Sciences, Arabian Gulf University, Manama, Kingdom of Bahrain.
Insights
Over-the-counter antidiarrheals pose risks for children. Loperamide, diphenoxylate, and atropine/diphenoxylate showed significant safety signals, including cardiac events and fatalities, necessitating cautious pediatric use.
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.
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.
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