Brompheniramine Should Not Be Used in a 3-Year-Old Child
OTC cough and cold medications containing brompheniramine should be avoided in all children below 6 years of age due to lack of established efficacy and significant safety concerns, including 9 reported pediatric fatalities associated with brompheniramine. 1, 2
Critical Safety Evidence
The FDA's Nonprescription Drugs and Pediatric Advisory Committees reviewed adverse event data showing that between 1969 and September 2006, there were 69 fatalities associated with antihistamines in children aged ≤6 years, with 9 deaths specifically linked to brompheniramine. 1 The majority of these deaths (41 of 69) occurred in children below age 2 years, with drug overdose and medication errors being common contributing factors. 1
The FDA advisory committees recommended in October 2007 that OTC cough and cold medications should no longer be used for children below 6 years of age. 1 This recommendation was based on:
- Lack of established efficacy for symptomatic treatment of upper respiratory tract infections in children younger than 6 years 1
- Potential toxicity from these medications 1
- High risk of dosing errors, including use of multiple products simultaneously, accidental exposures, and intentional overdose 1
Why This Differs from Older Dosing Information
While older pharmacokinetic studies demonstrated that brompheniramine 4 mg produces measurable drug levels and H1-blockade in children (mean age 9.5 years), 3 and weight-based dosing nomograms have been studied in children aged 2-17 years, 4 these studies do not address the fundamental safety concerns that led to the FDA advisory committee recommendations against use in children under 6 years. 1
The guideline evidence clearly prioritizes safety over pharmacokinetic data, particularly given that controlled trials have shown antihistamine-decongestant combinations are not effective for upper respiratory tract infection symptoms in young children. 1
Appropriate Alternatives for This Age Group
Second-generation antihistamines (cetirizine, desloratadine, fexofenadine, levocetirizine, loratadine) have been shown to be well tolerated with a very good safety profile when used in young children for appropriate allergic indications. 1 These should be considered instead if antihistamine therapy is truly indicated for a diagnosed allergic condition (not common cold symptoms).
Clinical Context
Brompheniramine should only be considered for clear allergic indications such as allergic rhinitis or urticaria as diagnosed by a healthcare professional, not for common cold symptoms. 2 Even for allergic conditions in this age group, second-generation antihistamines are preferred due to their superior safety profile. 1
A subset of asthmatic children may experience bronchospasm and decreased pulmonary function after brompheniramine administration, which can be prevented with theophylline premedication but represents an additional safety concern. 5