Can Bromfed (brompheniramine and pseudoephedrine) be prescribed to a four-year-old with an upper respiratory infection?

Bromfed Should NOT Be Prescribed to a Four-Year-Old with an Upper Respiratory Infection

Bromfed (brompheniramine and pseudoephedrine) should be avoided in a four-year-old child with an upper respiratory infection due to lack of proven efficacy, significant safety concerns including reported fatalities, and explicit guideline recommendations against use in children under 6 years of age. 1

Evidence Against Use in Young Children

Safety Concerns and Mortality Data

The Journal of Allergy and Clinical Immunology guidelines document serious safety issues with these medications in young children:

• Between 1969 and 2006, there were 54 fatalities associated with decongestants (including 46 from pseudoephedrine) in children ≤6 years, with 43 deaths occurring in children under 1 year of age 1
• During the same period, 69 fatalities were associated with antihistamines (including 9 from brompheniramine specifically) in the same age group, with 41 deaths in children under 2 years 1
• Drug overdose and toxicity were common, resulting from use of multiple products, medication errors, accidental exposures, and intentional overdose 1

Lack of Efficacy

• Controlled trials have demonstrated that antihistamine-decongestant combination products are NOT effective for symptoms of upper respiratory tract infections in young children 1
• The efficacy of cold and cough medications for symptomatic treatment of upper respiratory tract infections has not been established for children younger than 6 years 1

FDA Label Restrictions

The FDA-approved drug label for Bromfed explicitly states:

• "Safety and effectiveness in pediatric patients below the age of 6 months have not been established" 2
• The product is contraindicated in nursing mothers due to "higher risk of intolerance of antihistamines in small infants generally, and in newborns and prematures in particular" 2

Guideline Recommendations

Clear Age-Based Restrictions

• The FDA's Nonprescription Drugs and Pediatric Advisory Committees recommended in October 2007 that OTC medications used to treat cough and cold no longer be used for children below 6 years of age 1
• Because of the potential toxicity of these medications, the use of these OTC drugs generally should be avoided in all children below 6 years of age 1, 3
• Major pharmaceutical companies (Wyeth, Novartis, Prestige Brands, and Johnson & Johnson) voluntarily removed their cough and cold medications for children under age 2 years from the OTC market in October 2007 1

Recommended Management Instead

Supportive Care Approach

For a four-year-old with an upper respiratory infection, the American Academy of Pediatrics recommends:

• Ensure adequate hydration to help thin secretions 3
• Use antipyretics such as acetaminophen or ibuprofen to manage fever and keep the child comfortable 3
• Gentle nasal suctioning may help improve breathing if nasal congestion is present 3

When to Consider Antibiotics

• Antibiotics should NOT be prescribed for typical viral URI symptoms without evidence of bacterial infection 1, 3
• Consider antibiotics only if specific bacterial infections are diagnosed (acute otitis media, acute bacterial sinusitis, or streptococcal pharyngitis) with appropriate diagnostic criteria 1

Safer Alternatives for Allergic Symptoms

If allergic rhinitis is contributing to symptoms (not typical viral URI):

• Second-generation antihistamines such as cetirizine, desloratadine, fexofenadine, levocetirizine, and loratadine have been shown to be well tolerated with a very good safety profile in young children 1
• These are preferred over first-generation antihistamines like brompheniramine for any indication in this age group 1

Critical Pitfalls to Avoid

• Never prescribe combination antihistamine-decongestant products to children under 6 years for URI symptoms 1, 3
• Avoid topical decongestants in young children due to narrow therapeutic margin and risk of cardiovascular/CNS side effects 1, 3
• Do not use multiple cough/cold products simultaneously, as this increases overdose risk 1
• Recognize that most URIs in children are viral and self-limited, requiring only supportive care 1, 3

Reassessment Criteria

• Review the child within 48 hours if symptoms are deteriorating or not improving 3
• If cough persists beyond 4 weeks, systematic evaluation using pediatric-specific algorithms is required 1, 3
• Red flags requiring immediate evaluation include respiratory rate >50 breaths/min, difficulty breathing, grunting, cyanosis, poor feeding, or signs of dehydration 3