Do Not Give Nasatapp to Children Under 6 Years with Colds
Nasatapp (containing phenylpropanolamine and brompheniramine) should NOT be given to children under 6 years of age with colds due to lack of efficacy and significant safety concerns, including reported fatalities. Cetirizine, however, can be safely used in young children and has a well-established safety profile 1.
Age-Based Recommendations
Children Under 6 Years
- Avoid Nasatapp completely - The combination of decongestant (phenylpropanolamine) and first-generation antihistamine (brompheniramine) is not recommended 1
- Cetirizine is safe to use - Second-generation antihistamines like cetirizine have been shown to be well-tolerated with an excellent safety profile in young children 1
Children 6 Years and Older
- Nasatapp may be considered with caution, though evidence for effectiveness in treating common cold symptoms remains limited
- Cetirizine remains the safer option with better documented safety
Critical Safety Concerns with Nasatapp Components
The evidence reveals serious mortality and morbidity risks:
Decongestant (Phenylpropanolamine) Risks:
- Between 1969-2006, there were 54 fatalities in children ≤6 years associated with decongestants in OTC preparations 1
- 43 of these deaths occurred in children under 1 year of age 1
- Common causes: drug overdose, medication errors, use of multiple cold products, accidental exposures 1
First-Generation Antihistamine (Brompheniramine) Risks:
- 9 fatalities specifically linked to brompheniramine in the same reporting period 1
- Total of 69 deaths associated with antihistamines in this age group, with 41 occurring in children under 2 years 1
Why These Medications Don't Work for Colds
Lack of Efficacy:
- Controlled trials consistently show antihistamine-decongestant combinations are not effective for upper respiratory infection symptoms in young children 1
- The common cold is a viral illness where these medications provide no proven benefit 2
- Multiple studies demonstrate no improvement in runny nose, nasal congestion, or cough compared to placebo 3, 4, 5
Regulatory Actions and Recommendations
In October 2007, the FDA's Nonprescription Drugs and Pediatric Advisory Committees recommended that OTC cough and cold medications no longer be used in children below 6 years of age 1. Major manufacturers (Wyeth, Novartis, Prestige Brands, Johnson & Johnson) voluntarily removed these products for children under 2 years from the market 1.
Why Cetirizine is the Better Choice
If antihistamine treatment is desired:
- Cetirizine has demonstrated safety in young children across multiple studies 1
- Well-tolerated with a very good safety profile 1
- Part of the second-generation antihistamine class (along with desloratadine, fexofenadine, levocetirizine, loratadine) that lacks the serious adverse effects of first-generation agents 1
Common Pitfalls to Avoid
- Combining multiple cold medications - This significantly increases overdose risk and was a common factor in reported fatalities 1
- Assuming "over-the-counter" means "safe for children" - Age restrictions exist for critical safety reasons
- Using adult formulations or dosing - Never appropriate for young children
- Treating viral colds with unnecessary medications - Most cold symptoms resolve without pharmacologic intervention 2
What Actually Works for Pediatric Colds
Based on the evidence 2:
- Nasal saline irrigation - Has benefits for symptom relief, especially in children
- Honey (for children >1 year) - May offer relief for cough symptoms
- Supportive care - Adequate hydration, rest
- Acetaminophen or ibuprofen - For fever or discomfort (not for cough/congestion)
The bottom line: Skip the Nasatapp entirely in children under 6 years. If you want to use an antihistamine, cetirizine is the evidence-based, safe choice.