What are the recommendations for using decongestants in children?

Decongestant Use in Children

Decongestants should not be used in children under 6 years of age due to potential toxicity and lack of established efficacy. 1, 2

Age-Based Recommendations

• Children under 6 years: Decongestants (both oral and topical) should be avoided completely due to safety concerns and lack of proven efficacy 1
• Children 6-12 years: Oral decongestants may be used at appropriate doses with caution and monitoring for side effects 1, 3
• Children over 12 years: Can use adult dosing as directed on product labeling 3

Safety Concerns

Serious Risks in Young Children

• Between 1969 and 2006, there were 54 fatalities associated with decongestants (pseudoephedrine, phenylephrine, and ephedrine) in children, with 43 deaths occurring in children under 1 year 1, 2
• Serious adverse effects reported in young children include:
  • Agitated psychosis
  • Ataxia
  • Hallucinations
  • Death in rare cases 1, 2
• Even at recommended doses, these medications can cause:
  • Tachyarrhythmias
  • Insomnia
  • Hyperactivity 1, 2

Specific Decongestant Types

Oral Decongestants

• Pseudoephedrine is more effective than phenylephrine due to better oral bioavailability 4
• FDA-approved labeling for pseudoephedrine states "do not use this product in children under 6 years of age" 3
• Controlled trials have shown that antihistamine-decongestant combination products are not effective for symptoms of upper respiratory tract infections in young children 1, 2

Topical Decongestants

• Topical decongestants (e.g., oxymetazoline, xylometazoline) should be used with particular care in children under 1 year due to the narrow margin between therapeutic and toxic doses 1, 5
• Risk of cardiovascular and CNS side effects is higher in young children 1, 5
• FDA approval for oxymetazoline is for patients ≥6 years of age 5
• Short-term use only (≤3 days) is recommended to avoid rhinitis medicamentosa (rebound congestion) 1

Alternative Options for Children

• Second-generation antihistamines: Cetirizine, desloratadine, fexofenadine, levocetirizine, and loratadine have been shown to be well-tolerated with good safety profiles in young children 2
• Intranasal corticosteroids: Most effective medication class for controlling symptoms of allergic rhinitis 2
• Saline nasal irrigation: Provides modest benefit with minimal side effects 2

Common Pitfalls to Avoid

• Medication errors: Overdose errors often result from use of multiple cold/cough products containing the same active ingredients 1
• Extended use of topical decongestants: Rhinitis medicamentosa can develop as early as the third day of treatment 1
• Combining with stimulant medications: Increased risk of adverse events when decongestants are used concomitantly with ADHD medications 1, 2
• Ignoring FDA recommendations: Despite FDA advisory committee recommendations against use in children under 6, some caregivers continue to administer these medications for comfort 6

Monitoring Recommendations

• For children 6-12 years using appropriate doses of oral decongestants:
  • Monitor for changes in blood pressure 1, 4
  • Watch for signs of stimulant effects (insomnia, hyperactivity) 1, 2
  • Avoid use in children with certain conditions such as cardiovascular disease, hyperthyroidism, and closed-angle glaucoma 1, 4

The evidence clearly shows that the risks of decongestant use in children under 6 years outweigh any potential benefits, with multiple studies showing lack of efficacy and concerning safety profiles 1, 2.