Sodium Chloride Spray is the Only Safe Option for Infants Under 6 Months
Antihistamines are contraindicated in infants under 6 months due to documented fatalities and serious adverse events, making sodium chloride (saline) nasal drops or irrigation the recommended first-line treatment for nasal congestion in this age group. 1
Why Antihistamines Must Be Avoided
The FDA and American Academy of Pediatrics explicitly recommend against using antihistamines in children under 6 years, with particular concern for infants under 2 years. 2, 1
Between 1969-2006, there were 69 fatalities associated with antihistamines in children, with 41 deaths occurring specifically in children under 2 years of age. 2
Antihistamines in infants have been associated with agitated psychosis, ataxia, hallucinations, and death even at recommended doses. 1
Most second-generation antihistamines (cetirizine, loratadine) only have approval starting at age 6 months to 2 years in controlled studies, with no safety data for infants under 6 months. 2
Saline Nasal Irrigation: The Safe and Effective Alternative
Isotonic and hypertonic saline solutions provide modest benefit for reducing nasal congestion symptoms with minimal side effects, low cost, and generally good patient acceptance. 2, 1
Saline nasal lavage is recommended as adjunct therapy for nasal congestion in newborns and infants, and is deemed safe and effective for treatment of nasal congestion in babies with viral infections. 3
The American Academy of Otolaryngology recommends saline irrigation as first-line treatment for symptomatic relief of nasal congestion in infants under 6 months. 1
Nasal irrigation with physiological saline solution, followed by gentle aspiration, represents an effective method for prevention and control of nasal congestion in term or preterm neonates. 3
Clinical Rationale for This Age Group
Neonates are obligate nasal breathers until at least 2 months old, making nasal obstruction particularly problematic and potentially causing respiratory distress, altered sleep cycles, increased risk of obstructive apnea, and feeding difficulties. 3
Due to the lack of alternative safe medications in children younger than 12 years of age, and the complete absence of safety data for antihistamines in infants under 6 months, saline irrigation is the only evidence-based option. 3
Important Safety Caveat
- While some studies have examined xylometazoline (a decongestant) in hospitalized infants and found it relatively safe, this should not be extrapolated to routine outpatient use in infants under 6 months without close medical supervision. 4