Saline Nasal Irrigation for Infants Under 6 Months
For nasal congestion in infants under 6 months, use sodium chloride (saline) nasal drops or irrigation, as antihistamines are contraindicated in this age group due to serious safety concerns including fatalities. 1, 2
Why Antihistamines Are Contraindicated
OTC cough and cold medications, including antihistamines, should not be used in children below 6 years of age according to FDA advisory committee recommendations, with particular concern for infants under 2 years 1
Between 1969-2006, there were 69 fatalities associated with antihistamines in children, with 41 deaths occurring in children under 2 years of age 3
Antihistamines in infants and young children have been associated with agitated psychosis, ataxia, hallucinations, and even death, even at recommended doses 1
Most second-generation antihistamines have FDA approval only starting at age 2 years, with cetirizine and loratadine being the only exceptions that extend down to 6 months in controlled studies, but this is still above your patient's age threshold 3
The dosages at which cough and cold medications can cause illness or death in children under 2 years are not known, making their use particularly dangerous 2
Recommended Treatment: Saline Irrigation
Isotonic and hypertonic saline solutions provide modest benefit for reducing nasal congestion symptoms with minimal side effects, low cost, and generally good patient acceptance 3
Saline irrigation is recommended by the American Academy of Otolaryngology as adjunctive therapy for nasal symptoms and is safe for use in infants 3
This approach has no risk of systemic toxicity or adverse events that plague antihistamine use in this vulnerable age group 3
Clinical Algorithm for Infants Under 6 Months
First-line: Saline nasal drops or irrigation for symptomatic relief of nasal congestion 3
Avoid all antihistamines and decongestants due to lack of safety data and documented fatalities in this age group 1, 2
If symptoms persist or worsen, refer to pediatric allergist or otolaryngologist for evaluation of underlying causes rather than escalating pharmacotherapy 3
Critical Safety Pitfall
Never prescribe antihistamines off-label for infants under 6 months, even if parents request them or report use in older siblings—the risk-benefit ratio is unacceptable given documented fatalities and lack of efficacy data 1, 2
Caregivers should be explicitly counseled not to administer any OTC cough and cold medications without consulting a healthcare provider, as combination products may contain multiple dangerous ingredients 2