Anti-Diarrheal Medications in Infants Can Cause Ileus
Anti-diarrheal medications, particularly loperamide, should never be given to children under 18 years of age with acute diarrhea due to documented risks of ileus, abdominal distension, lethargy, and death. 1
Evidence of Ileus Risk in Infants
The risk of ileus from anti-diarrheal agents in infants is well-established and severe:
Deaths have been reported in 0.54% of children given loperamide, with all deaths occurring in children under 3 years of age. 1
Adverse events including ileus, abdominal distension, and lethargy consistently occurred in pediatric patients receiving loperamide treatment. 1
A report from Pakistan documented 18 cases of severe abdominal distention associated with loperamide use, including at least 6 deaths. 1
In a controlled clinical study, 6 of 28 patients administered loperamide experienced side effects (ileus, drowsiness) requiring discontinuation of therapy. 1
The FDA drug label explicitly states that loperamide is contraindicated in pediatric patients less than 2 years of age due to risks of respiratory depression and serious cardiac adverse reactions, and notes rare reports of paralytic ileus associated with abdominal distention, most occurring in children under 2 years. 2
Mechanism of Harm
Loperamide is a locally acting opioid receptor agonist that decreases muscular tone and motility of the intestinal wall, which can lead to toxic ileus in young children. 1
Pediatric patients may be more sensitive to CNS effects including altered mental status, somnolence, and respiratory depression than adults. 2
Dehydration, particularly in children under 6 years of age, further increases the variability and risk of adverse responses to loperamide. 2
Clinical Evidence from Studies
A study of 30 infants receiving loperamide (0.8 mg/kg/day) found that 2 infants had to be withdrawn because ileus developed in one and persistent severe vomiting occurred in the other, with 4 additional infants developing drowsiness. 3
Despite theoretical benefits, available data do not demonstrate effectiveness of antimotility agents in reducing diarrhea volume or duration in children, while side effects are well-documented. 1
Guideline Recommendations
The Infectious Diseases Society of America provides a strong recommendation (moderate quality evidence) that antimotility drugs like loperamide should NOT be given to children under 18 years of age with acute diarrhea. 1, 4
The American Academy of Pediatrics reinforces this recommendation, emphasizing that antimotility agents should be avoided in all pediatric patients with acute diarrhea. 4, 5
Loperamide should be used with special caution in pediatric patients because of their greater variability of response, and the safety and effectiveness in pediatric patients with chronic diarrhea have not been established. 2
Appropriate Management Instead
Oral rehydration solution (ORS) is the first-line therapy for mild to moderate dehydration in infants and children. 1, 4
Intravenous fluids should be administered for severe dehydration, shock, altered mental status, failure of ORS therapy, or ileus. 1
Age-appropriate diet should be resumed during or immediately after rehydration is completed. 1, 4
Human milk feeding should be continued throughout the diarrheal episode. 1, 4
Critical Pitfall to Avoid
The most dangerous pitfall is administering any antimotility agent (loperamide, diphenoxylate, or other opioid-based drugs) to infants or children, as this shifts therapeutic focus away from appropriate fluid and electrolyte therapy, can interfere with oral rehydration, and carries documented mortality risk. 1, 4, 6