What FDA‑approved therapies are available for treating allergic rhinitis and cough in infants and young children?

FDA-Approved Treatment for Rhinitis and Cough in Infants and Young Children

OTC cough and cold medications should be avoided in all children below 6 years of age due to lack of efficacy and potential for serious toxicity including death. 1

Critical Safety Warning

Between 1969 and 2006, there were 54 fatalities associated with decongestants and 69 fatalities with antihistamines in children ≤6 years, with 43 decongestant deaths occurring in infants under 1 year. 1 The FDA's Nonprescription Drugs and Pediatric Advisory Committees recommended in 2007 that OTC cough and cold medications no longer be used for children below 6 years of age. 1

For Allergic Rhinitis in Young Children

First-Line Treatment: Intranasal Corticosteroids

Intranasal corticosteroids are the most effective medication class for controlling allergic rhinitis symptoms and should be the primary treatment. 1 They effectively control all four major symptoms: sneezing, itching, rhinorrhea, and nasal congestion.

• Safety profile: When used at recommended doses, intranasal corticosteroids show no clinically significant systemic effects on growth, HPA axis, bone density, or ocular pressure in children 1
• Onset of action: 3-12 hours 1
• All available intranasal corticosteroids show similar clinical efficacy regardless of differences in potency or formulation 1

Second-Line Treatment: Second-Generation Oral Antihistamines

Second-generation antihistamines (cetirizine, desloratadine, fexofenadine, levocetirizine, loratadine) are well-tolerated with excellent safety profiles in young children and represent the only safe oral option. 1

These agents contrast sharply with first-generation antihistamines found in OTC products, which have been associated with multiple fatalities in young children.

For Cough in Young Children

No FDA-Approved Medications

There are no FDA-approved medications for treating cough in children under 6 years. 2 The 2018 FDA ruling limited prescription opioid cough medications to adults ≥18 years only.

Evidence-Based Approach:

1. Honey (for children ≥1 year): May offer more relief than no treatment, diphenhydramine, or placebo for acute cough 2

2. Avoid codeine-containing medications due to potential for serious side effects including respiratory distress 2

3. Avoid OTC cough medications: No evidence of efficacy and associated with adverse events including death from toxicity 2

4. Treat underlying etiology: If cough is due to allergic rhinitis, treat with intranasal corticosteroids as above

Critical Pitfalls to Avoid

• Never use topical decongestants below age 1 year - narrow margin between therapeutic and toxic dose increases cardiovascular and CNS side effect risk 1

• Antihistamine-decongestant combinations are ineffective for upper respiratory infections in young children 1

• Multiple medication errors occur from using multiple cold/cough products simultaneously, leading to unintentional overdose 1

Algorithm for Treatment Selection

For allergic rhinitis in children <6 years:

1. Start with intranasal corticosteroid (any formulation)
2. If inadequate response or non-compliance, add second-generation oral antihistamine
3. Never add OTC cough/cold medications

For cough in children <6 years:

1. Identify and treat underlying cause (if allergic rhinitis → intranasal corticosteroid)
2. For symptomatic relief in children ≥1 year: honey only
3. Avoid all OTC cough medications and codeine products

This evidence-based approach prioritizes mortality prevention while providing the only treatments with demonstrated safety and efficacy in this vulnerable population.