Use of Phenylpropanolamine and Brompheniramine in a One-Month-Old Infant
Do not use phenylpropanolamine and brompheniramine in a one-month-old infant. These medications should be avoided in all children below 6 years of age due to lack of established efficacy and significant safety concerns, including documented fatalities in infants.
Evidence-Based Contraindication
FDA and Professional Society Recommendations
The FDA's Nonprescription Drugs and Pediatric Advisory Committees recommended in 2007 that OTC cough and cold medications no longer be used for children below 6 years of age 1
Multiple 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
Controlled trials have demonstrated that antihistamine-decongestant combination products are not effective for symptoms of upper respiratory tract infections in young children 1
Documented Safety Concerns
The safety profile for these medications in infants is particularly alarming:
Between 1969 and September 2006, there were 54 fatalities associated with decongestants (including phenylpropanolamine) in children age 6 years or younger, with 43 deaths occurring in infants below age 1 year 1
During the same period, there were 69 fatalities associated with antihistamines (including brompheniramine) in the same age group, with 41 deaths reported below age 2 years 1
Drug overdose and toxicity were common events, resulting from use of multiple cold/cough products, medication errors, accidental exposures, and intentional overdose 1
Clinical Evidence in Young Children
One study specifically evaluated the addition of nasal oxymetazolone and oral syrup containing brompheniramine and phenylpropanolamine versus placebo in children with acute maxillary sinusitis, finding similar responses between groups and concluding that decongestant-antihistamine need not be given 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
Common Pitfalls to Avoid
Do not assume that lower doses make these medications safe in infants - the lack of efficacy combined with documented fatalities makes any use inappropriate 1
Do not use these medications even for conditions where they might seem logical (allergic rhinitis, upper respiratory infections) - the evidence shows no benefit and significant harm 1
Be aware that a subset of asthmatic children may experience decreased pulmonary function with brompheniramine, making it particularly dangerous in infants with any respiratory compromise 2
Safer Alternatives
While 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, at one month of age, consultation with a pediatrician is essential before using any medication for respiratory symptoms.