Cetirizine for Rhinorrhea and Cough in Children Under 2 Years
Cetirizine should not be used for treating rhinorrhea and cough in children under 2 years of age due to lack of established efficacy for these symptoms and potential safety concerns.
Safety Considerations
- The FDA labeling for cetirizine indicates it is approved for children 6 years and older, not for children under 2 years 1
- While second-generation antihistamines like cetirizine have been shown to have a better safety profile than first-generation antihistamines in young children, they are still not recommended for treating symptoms of upper respiratory tract infections in children under 2 years 2
- The FDA's Nonprescription Drugs and Pediatric Advisory Committees recommended that OTC medications used to treat cough and cold no longer be used for children below 6 years of age 2
- Adverse events have been reported with antihistamine use in young children, including insomnia in a 23-month-old child taking cetirizine 3
Efficacy Considerations
- Controlled trials have shown that antihistamine products are not effective for symptoms of upper respiratory tract infections in young children 2
- The Cochrane review on anti-histamines for prolonged non-specific cough in children found uncertain efficacy, similar to findings for acute cough 4
- While cetirizine is licensed in Europe for children older than 2 years and in the USA for children older than 6 months for allergic rhinitis and chronic urticaria, this does not extend to treating rhinorrhea and cough due to upper respiratory infections 5
Alternative Approaches
- Intranasal corticosteroids are the most effective medication class for controlling symptoms of allergic rhinitis, but their use in children under 2 years should be carefully considered 2
- For rhinorrhea and cough due to upper respiratory infections in children under 2 years, supportive care measures are preferred over medication 2
- If allergic rhinitis is suspected as the underlying cause of symptoms in children approaching 2 years of age, consultation with a pediatric allergist may be warranted before considering any medication 6
Clinical Decision Making
- Distinguish between infectious and allergic causes of rhinorrhea, as treatment approaches differ 2
- For infectious causes in children under 2 years, focus on supportive care rather than medications 2
- For allergic causes in children approaching 2 years, cetirizine might be considered only after careful evaluation by a specialist, weighing potential benefits against risks 5
- Monitor closely for adverse effects if any medication is used in this age group 6, 3
Key Warnings
- Between 1969 and 2006, there were 69 fatalities associated with antihistamines contained in OTC and prescription agents for children under 6 years, with 41 reported in children under 2 years 2
- Drug overdose and toxicity were common events reported in these cases, often resulting from medication errors, accidental exposures, or use of multiple products 2
- The risk-benefit ratio does not favor using cetirizine for rhinorrhea and cough in children under 2 years when the cause is a respiratory infection 2, 4