Otilonium Bromide in Pediatric Patients
Otilonium bromide should not be used in pediatric patients with IBS or other gastrointestinal disorders, as there is no evidence supporting its safety or efficacy in children, and all available guidelines and studies focus exclusively on adult populations.
Evidence Base and Population Limitations
The available evidence for otilonium bromide is derived entirely from adult studies, with no pediatric data:
- Adult-only evidence: All clinical trials evaluating otilonium bromide enrolled adult patients (mean age 46 years in the largest trial), with no studies examining pediatric populations 1
- Guideline recommendations: The British Society of Gastroenterology recommends antispasmodics including otilonium bromide as first-line treatment for IBS, but this applies only to adult patients 2
- Mechanism of action: While otilonium bromide works through calcium channel blockade and muscarinic receptor antagonism in colonic smooth muscle, these mechanisms have only been studied in adult tissues 3, 4, 5
Why Pediatric Use Is Not Recommended
Lack of safety data in children represents a critical gap:
- No pharmacokinetic studies have evaluated how children absorb, distribute, or eliminate otilonium bromide
- No dosing guidelines exist for pediatric weight ranges or developmental stages
- Potential risks of anticholinergic effects (constipation, urinary retention, cognitive effects) have not been assessed in growing children 3
IBS diagnosis itself is problematic in pediatrics:
- The adult IBS criteria used in otilonium bromide trials may not apply to children with functional abdominal pain
- Pediatric functional gastrointestinal disorders require different diagnostic approaches than adult IBS
Alternative Approaches for Pediatric Gastrointestinal Symptoms
For pediatric patients with IBS-like symptoms, consider evidence-based alternatives:
- First-line options: Dietary modifications and soluble fiber (psyllium) have better-established safety profiles in children 6
- Antispasmodics with pediatric data: If antispasmodic therapy is needed, select agents with published pediatric safety data rather than otilonium bromide
- Neuromodulators: Tricyclic antidepressants may be considered in adolescents with refractory symptoms, though this requires careful risk-benefit assessment 7
Critical Caveat
Off-label use without evidence poses unacceptable risk: Using otilonium bromide in children would constitute off-label prescribing without any supporting data on appropriate dosing, safety, or efficacy. The 18% reduction in abdominal pain and 14% improvement in bloating seen in adults cannot be extrapolated to pediatric patients 2.