FDA Approval Status of Bromfed (Brompheniramine) in Children Under 6 Years
Bromfed is NOT FDA approved for children under 6 months of age, and safety and effectiveness have not been established in this age group. 1
Age-Specific Approval and Safety Data
Children Under 6 Months
- The FDA drug label explicitly states: "Safety and effectiveness in pediatric patients below the age of 6 months have not been established." 1
- Bromfed is contraindicated in nursing mothers specifically because of the higher risk of intolerance of antihistamines in small infants generally, and in newborns and prematures in particular. 1
Children 6 Months to Under 6 Years
- While the FDA label does not explicitly state approval for children 6 months to under 6 years, it only excludes those under 6 months. 1
- However, FDA advisory committees recommended in 2007 that OTC cough and cold medications should not be used in children below 6 years of age due to lack of efficacy and safety concerns. 2
- Between 1969-2006, there were 69 fatalities associated with antihistamines (including brompheniramine) in children, with 41 deaths occurring in children under 2 years. 3
Critical Safety Considerations for Young Children
Specific Risks with Brompheniramine
- Brompheniramine is a first-generation antihistamine that was associated with significant pediatric fatalities historically. 2
- The FDA and American Academy of Pediatrics recommend against using first-generation antihistamines like brompheniramine in children under 6 years due to significant safety concerns, including risk of serious adverse events and fatalities. 3
Combination Product Concerns
- Bromfed contains both an antihistamine (brompheniramine) and a decongestant (pseudoephedrine), creating dual risks. 2
- These combination products have not been proven effective for cough and carry unnecessary risk in young children. 2
Practical Clinical Algorithm
For children under 6 months: Bromfed is not approved and should not be used. 1
For children 6 months to under 6 years: While technically not explicitly prohibited by the FDA label for those over 6 months, current FDA advisory recommendations strongly discourage use of OTC cough and cold medications (including antihistamine-decongestant combinations like Bromfed) in this entire age group. 2
Safer alternatives for this age group include:
- Second-generation antihistamines (cetirizine, loratadine) for children over 6 months, which have better safety profiles. 3
- Intranasal corticosteroids as first-line treatment for allergic symptoms. 3
- Saline irrigation as adjunctive non-pharmacologic therapy. 3
Common Pitfall to Avoid
Do not assume that because a medication has been used historically or is available OTC that it is safe or appropriate for young children—the lack of FDA approval under 6 months and the 2007 FDA advisory against use under 6 years reflect serious safety concerns that supersede historical practice patterns. 2, 1