Are proton pump inhibitors (PPIs) contraindicated in pediatric patients?

Proton Pump Inhibitors in Pediatric Patients: Indications and Contraindications

Proton pump inhibitors (PPIs) are not contraindicated in pediatric patients but should be used only for specific indications of gastroesophageal reflux disease (GERD) rather than physiologic gastroesophageal reflux (GER). 1

Appropriate Use of PPIs in Pediatric Patients

• PPIs are explicitly indicated only for patients with diagnosed GERD, not for uncomplicated physiologic reflux (GER) 1
• PPIs are approved for children older than 1 year for short-term treatment of symptomatic GERD, healing of erosive esophagitis, treatment of peptic ulcer disease, and eradication of Helicobacter pylori 2
• Esomeprazole has recently been approved for treatment of erosive esophagitis in infants 3
• Lifestyle changes should be emphasized as first-line therapy for both GER and GERD before considering medication 1

Concerns and Risks with PPI Use in Children

• There is significant concern about the overprescription of acid suppressants, especially PPIs, in the pediatric population 1
• Adverse effects occur in approximately 6.98% of pediatric patients taking PPIs 4
• The most common adverse effects include:
  • Respiratory tract complications
  • Gastrointestinal complications
  • Urinary tract infections
  • Asthma
  • ENT infections 4
• Evidence suggests that acid suppression with PPIs may be a risk factor for:
  • Community-acquired pneumonia
  • Gastroenteritis
  • Candidemia
  • Necrotizing enterocolitis in preterm infants 1

Dosing and Administration Guidelines

• For children 1-11 years with GERD:
  • ≤30 kg: 15 mg once daily for up to 12 weeks

  • 30 kg: 30 mg once daily for up to 12 weeks 5

• For adolescents 12-17 years:
  • Non-erosive GERD: 15 mg once daily for up to 8 weeks
  • Erosive esophagitis: 30 mg once daily for up to 8 weeks 5
• PPIs should be taken before meals 5

Clinical Decision Algorithm for PPI Use in Children

1. Determine if the child has GER or GERD:

   • GER: Physiologic reflux without troublesome symptoms or complications 1
   • GERD: Reflux with troublesome symptoms (feeding refusal, recurrent vomiting, poor weight gain, irritability, sleep disturbance) or complications 1

2. For children with GER only:

   • Implement conservative measures only (no medications) 1
   • Provide parental reassurance and education 1
   • Consider lifestyle modifications appropriate for age 1

3. For children with confirmed GERD:

   • Start with lifestyle modifications 1
   • If symptoms persist, consider PPI therapy for 4-8 weeks 1
   • Reevaluate response after treatment period 1
   • Discontinue if no improvement or symptoms resolve 1

Important Caveats and Pitfalls

• PPIs should not be used when there are no clinical features of GERD 1
• PPIs should not be used for longer than 4-8 weeks without further evaluation 1
• Long-term PPI use should be limited to children with underlying GERD-predisposing disorders (neuromotor disorders, esophageal atresia) 6
• PPIs are contraindicated in patients with known hypersensitivity to any component of the formulation 5
• The metabolism of PPIs differs in children compared with adults, with CYP2C19 and CYP3A4 enzymes reaching adult levels at 5-6 months after birth 3

Safety of Long-term Use

• Preliminary data suggest that PPIs may be efficacious and safe for continuous use for up to 11 years in children with GERD-predisposing disorders 6
• Few severe adverse events have been reported with long-term use of omeprazole or lansoprazole in pediatric patients 7, 6
• However, long-term gastric acid suppression in children has been linked to increased risks of infections, bone fractures, and allergy 2

Remember that distinguishing between GER and GERD is crucial to avoid unnecessary PPI prescriptions in children with uncomplicated physiologic reflux, for whom conservative measures are the only indicated therapy 1.