Bromfed (Brompheniramine and Pseudoephedrine) is NOT Suitable for a 3-Year-Old Child
Bromfed (brompheniramine and pseudoephedrine) should not be used in children under 6 years of age due to safety concerns and lack of established efficacy. 1, 2
Safety Concerns with Bromfed Components in Young Children
Brompheniramine (Antihistamine)
- The American Academy of Allergy, Asthma, and Immunology specifically identifies brompheniramine as one of the antihistamines associated with fatalities in young children 1, 2
- Between 1969-2006, there were 69 fatalities associated with first-generation antihistamines in children, with 9 specifically linked to brompheniramine 1
- 41 of these deaths occurred in children under 2 years of age 1
Pseudoephedrine (Decongestant)
- FDA data shows 46 fatalities associated with pseudoephedrine in children, with 43 occurring in children under 1 year of age 1
- Pseudoephedrine can cause significant adverse effects including:
- Elevated blood pressure
- Palpitations
- Irritability
- Tremor
- Sleep disturbances 1
Regulatory Guidance and Expert Recommendations
- In 2007, the FDA's Nonprescription Drugs and Pediatric Advisory Committees recommended that OTC cough and cold medications (including antihistamine-decongestant combinations) not be used for children under 6 years of age 1, 2
- Major pharmaceutical companies voluntarily removed cough and cold medications for children under 2 years from the OTC market 1
- Controlled trials have shown that antihistamine-decongestant combination products are not effective for symptoms of upper respiratory tract infections in young children 1
Overdose Risk Factors
The risk of overdose is particularly concerning with these medications in young children due to:
- Use of multiple cold/cough products simultaneously
- Medication dosing errors
- Accidental exposures
- The challenging dosage ratio in combination products 3, 4
Safer Alternatives for Young Children
If treatment for allergic symptoms is necessary in a 3-year-old:
- Second-generation antihistamines (cetirizine, desloratadine, fexofenadine, levocetirizine, and loratadine) have demonstrated better safety profiles in young children 1, 2
- For nasal symptoms, intranasal corticosteroids are the most effective medication class for controlling symptoms of allergic rhinitis 1
Special Considerations
- A subset of asthmatic children may experience worsening of pulmonary function with brompheniramine 5
- The long half-life of brompheniramine (12.4 hours in children) increases risk of accumulation and toxicity with repeated dosing 6
- A documented case report describes a fatal intoxication in an infant involving brompheniramine and pseudoephedrine 4
In conclusion, the risks of using Bromfed in a 3-year-old child significantly outweigh any potential benefits. Current guidelines and safety data strongly recommend against using this combination in children under 6 years of age.