Are nasal drops contraindicated in children and infants?

Nasal Drops in Children and Infants: Safety Considerations

Topical decongestant nasal drops should be used with extreme caution in children under 1 year of age and are generally not recommended for children under 6 years due to significant safety risks including cardiovascular and central nervous system side effects. 1

Safety Concerns and Contraindications

• Topical vasoconstrictors (nasal drops containing imidazoline derivatives like oxymetazoline, xylometazoline, and naphazoline) should be used with care in children below 1 year of age due to the narrow margin between therapeutic and toxic doses, increasing the risk for cardiovascular and CNS side effects 1

• Significant safety concerns exist for children under 6 years, with documented cases of fatalities associated with decongestants in OTC preparations, particularly in children under 1 year 1

• Imidazoline derivative nasal drops can cause severe central nervous system depression including:

  • Disturbances of consciousness progressing to coma
  • Hypothermia
  • Bradycardia
  • Sweating
  • These effects are particularly pronounced in children 2, 3

• Anglo-Saxon pharmacotherapy excludes the application of naphazoline nasal drops in children younger than six years due to these safety concerns 2

Evidence of Harm

• Between 1969 and 2006, there were 54 documented fatalities associated with decongestants (pseudoephedrine, phenylephrine, and ephedrine) in children under 6 years, with 43 of these deaths occurring in infants under 1 year 1

• Overdose can occur easily due to:

  • Containers inadequate for proper dosage
  • Difficulty in administering drops to young children
  • Bottle position during administration (inverted position can deliver up to 75 times the intended dose) 4

• Clinical manifestations of toxicity include somnolence, skin pallor, bradycardia, bradypnea, and hypothermia 2

Regulatory Guidance

• In 2007, the FDA's Nonprescription Drugs and Pediatric Advisory Committees recommended that OTC medications used to treat cough and cold (including nasal decongestants) no longer be used for children below 6 years of age 1

• Major pharmaceutical companies voluntarily removed their cough and cold medications for children under 2 years from the OTC market 1

Safer Alternatives

• Saline nasal lavage is recommended as a safe and effective alternative therapy for nasal congestion in neonates, infants, and children 5

• For allergic rhinitis in children under 6 years, second-generation antihistamines like cetirizine and loratadine have been shown to be well tolerated with good safety profiles 1, 6

• For children with more persistent symptoms requiring intranasal corticosteroids, mometasone furoate is approved for children aged 3 years and older, and fluticasone propionate for children aged 4 years and older 6

Administration Recommendations (if absolutely necessary)

• If nasal drops must be used in older children (>6 years), proper administration technique is crucial:
  • For optimal delivery, the Mygind position (lying with head tilted back and over the side of the bed) or Ragan position (lying on the side in a head-down position) is recommended 1
  • Short-term use only (no more than 3 days) to avoid rhinitis medicamentosa (rebound congestion) 1

Conclusion

Given the significant risks and documented fatalities, nasal decongestant drops containing vasoconstrictors should be avoided in children under 6 years of age, with particular caution in infants under 1 year. Safer alternatives like saline nasal lavage should be used instead for nasal congestion in these age groups.