What are the approved decongestants for a 1-year-old child?

Approved Decongestants for 1-Year-Olds

There are no approved decongestant medications recommended for routine use in 1-year-old children due to safety concerns and lack of proven efficacy. 1

Safety Concerns with Decongestants in Young Children

• Topical decongestants (such as oxymetazoline and xylometazoline) should be used with extreme caution in children below age 1 year due to the narrow margin between therapeutic and toxic doses, which increases the risk for cardiovascular and central nervous system side effects 1
• Between 1969 and 2006, there were 54 fatalities associated with decongestants (pseudoephedrine, phenylephrine, and ephedrine) in children under 6 years, with 43 of these deaths occurring in children below the age of 1 year 1
• Oral decongestants in infants and young children have been associated with serious adverse events including agitated psychosis, ataxia, hallucinations, and death 1
• In 2007, the FDA's Nonprescription Drugs and Pediatric Advisory Committees recommended that OTC cough and cold medications (including decongestants) should not be used for children below 6 years of age 1
• Major pharmaceutical companies voluntarily removed cough and cold medications for children under age 2 years from the OTC market in 2007 1

Alternative Approaches for Nasal Congestion in 1-Year-Olds

• Saline nasal irrigation or lavage can be used to remove debris from the nasal cavity and temporarily reduce tissue edema 1
• One study in children showed greater improvement in nasal airflow and quality of life with saline irrigation compared to placebo 1
• For severe nasal congestion that significantly impacts breathing or feeding, consultation with a healthcare provider is essential before considering any medication 2

Important Considerations for Providers

• The efficacy of cold and cough medications for symptomatic treatment of upper respiratory tract infections has not been established for children younger than 6 years 1
• Controlled trials have shown that antihistamine-decongestant combination products are not effective for symptoms of upper respiratory tract infections in young children 1
• If a healthcare provider determines that a topical decongestant is absolutely necessary in a 1-year-old (which should be extremely rare):
  • Use should be limited to the shortest possible duration (less than 3 days) 1
  • Careful monitoring for adverse effects is essential 1
  • Parents should be educated about proper dosing to avoid overdose 1

Pitfalls to Avoid

• Never substitute adult formulations or attempt to modify adult doses for use in infants 1
• Avoid using multiple products containing decongestants, as this increases the risk of overdose 1
• Do not use oral decongestants (pseudoephedrine, phenylephrine) in 1-year-olds due to safety concerns and lack of proven efficacy 1
• Be aware that some parents may purchase nasal sprays with unknown ingredients online or in pharmacies, which poses additional risks 3