Can lansoprazole be given to an 11-month-old patient with Gastroesophageal Reflux Disease (GERD)?

Lansoprazole Use in an 11-Month-Old Infant with GERD

Lansoprazole should not be routinely given to an 11-month-old infant with GERD, as it has been shown to be no more effective than placebo for symptom relief in this age group while significantly increasing the risk of serious adverse events, particularly lower respiratory tract infections. 1

Evidence Against Routine Use in Infants Under 1 Year

• A multicenter, double-blind, randomized controlled trial involving 162 infants aged 1-12 months with GERD symptoms found no difference in efficacy between lansoprazole and placebo for symptom improvement. 1

• Serious adverse events, particularly lower respiratory tract infections, occurred significantly more frequently with lansoprazole than placebo (OR 6.56; 95% CI 1.18-26.25). 1

• The FDA label explicitly states that lansoprazole was not effective in pediatric patients with symptomatic GERD aged one month to less than one year in controlled studies, and therefore safety and effectiveness have not been established in patients less than one year of age. 2

FDA-Approved Age Indications

• Lansoprazole is FDA-approved for children 1 to 11 years of age for up to 12 weeks to treat symptomatic GERD and erosive esophagitis. 2

• The FDA label specifically warns that lansoprazole is not effective for treating symptoms of GERD in children less than 1 year of age and may harm them. 2

• For children 1-11 years, dosing is weight-based: 15 mg once daily for children ≤30 kg or 30 mg once daily for children >30 kg. 2

Recommended First-Line Management for Infants

Instead of pharmacologic therapy, guideline-recommended conservative management should be prioritized: 3

• Smaller, more frequent feedings to reduce gastric distension 3

• Thickening formula (if formula-fed), though caution is advised in preterm infants due to necrotizing enterocolitis risk 3

• Maternal elimination diet (exclude milk and egg for 2-4 weeks if breastfeeding) 3

• Trial of extensively hydrolyzed or amino acid-based formula if formula-fed 3

• Upright positioning when awake and supervised 3

When PPI Therapy Might Be Considered (Off-Label)

If severe, refractory GERD with clear gastrointestinal symptoms persists despite conservative measures, off-label PPI use may be considered only after careful risk-benefit discussion: 3

• The American Thoracic Society recommends that PPIs should NOT be used when there are no clinical features of GERD, such as recurrent regurgitation or dystonic neck posturing in infants. 3

• If deemed absolutely necessary for severe disease, starting dose would be 0.7 mg/kg/day divided into 2 doses, with potential escalation up to 1.4-2.8 mg/kg/day if inadequate response. 3

• Duration should be limited to 4-8 weeks maximum without further evaluation. 3

Age-Dependent Pharmacokinetic Considerations

• Infants ≤10 weeks of age have significantly different pharmacokinetics compared to older infants, with 2-5 times higher drug exposure and prolonged elimination half-lives (55-90 hours vs. 30 hours in adults). 4

• An 11-month-old infant falls into the >10 weeks age group, which has clearance values more similar to adults but still requires careful dosing. 4

• Pharmacokinetic studies showed that infants >10 weeks receiving 1 mg/kg/day had mean AUC values similar to adults receiving 30 mg doses. 2

Critical Safety Concerns in This Age Group

The risk-benefit ratio strongly favors avoiding PPI therapy in infants under 1 year: 1, 3

• Increased risk of lower respiratory tract infections (6.56-fold increased odds) 1

• Potential for community-acquired pneumonia, gastroenteritis, and candidemia 3

• Long-term use associated with enterochromaffin cell hyperplasia, vitamin B12 deficiency, and bone fractures (though less relevant for short-term infant use) 3, 2

• Risk of Clostridium difficile-associated diarrhea 2

Clinical Decision Algorithm

1. First-line (all infants with GERD symptoms): Implement conservative measures including feeding modifications, positioning, and dietary interventions for 2-4 weeks 3

2. If symptoms persist: Re-evaluate diagnosis and consider referral to pediatric gastroenterology before initiating pharmacologic therapy 3, 5

3. Only if severe, refractory disease with clear GI symptoms: Consider off-label PPI use with informed consent regarding lack of proven efficacy and increased infection risk 1, 3

4. If PPI initiated: Re-evaluate response after 4-8 weeks and discontinue if no clear benefit 3

Common Pitfalls to Avoid

• Do not prescribe PPIs for uncomplicated infant reflux or "fussiness" without clear GERD symptoms, as this represents overuse without proven benefit and exposes infants to unnecessary infection risk. 1

• Do not continue PPI therapy beyond 4-8 weeks without specialist consultation and re-evaluation of the diagnosis. 3

• Avoid assuming that adult or older pediatric dosing can be extrapolated to infants, as pharmacokinetics are markedly different in this age group. 4