Is Bromfed (brompheniramine and pseudoephedrine) safe for children?

Bromfed (Brompheniramine and Pseudoephedrine) Safety in Children

Bromfed is not recommended for children under 6 years of age due to safety concerns including potential serious adverse effects and even death. 1, 2

Safety Concerns for Children

Age Restrictions

• The FDA label for Bromfed specifically states that safety and effectiveness have not been established in pediatric patients below 6 months of age 2
• The American Academy of Allergy, Asthma and Immunology recommends against using oral decongestants in children under 6 years due to safety concerns 1

Documented Risks

• Use of brompheniramine and pseudoephedrine in infants and young children has been associated with:
  • Agitated psychosis
  • Ataxia
  • Hallucinations
  • Death 1
• A case report documented a fatal cold medication intoxication in an infant involving brompheniramine, pseudoephedrine, and dextromethorphan 3

Pharmacology and Concerns

Brompheniramine (Antihistamine Component)

• First-generation antihistamine with significant anticholinergic effects
• Has a long half-life in children (12.4 hours) with peak concentrations occurring at 3.2 hours 4
• Can cause significant sedation and central nervous system effects

Pseudoephedrine (Decongestant Component)

• Alpha-adrenergic agent that acts as a vasoconstrictor
• Can cause elevated blood pressure, palpitations, loss of appetite, irritability, tremor, and sleep disturbance 1
• May have more pronounced cardiovascular effects in children due to their smaller body size

Age-Specific Recommendations

Children Under 6 Years

• Avoid Bromfed completely - OTC cough and cold medications containing decongestants and antihistamines are not recommended for children under 6 years 1
• FDA advisory committees have recommended against using these medications in young children due to reported fatalities and serious adverse events 1

Children 6 Years and Older

• May be used with caution in appropriate doses under medical supervision
• Should be monitored for side effects including:
  • Drowsiness
  • Excitability
  • Cardiovascular effects
  • Sleep disturbances

Alternatives for Young Children

For children under 6 years with nasal congestion or allergic symptoms:

• Nasal saline irrigation has possible benefits for relieving symptoms of acute upper respiratory tract infections 1
• Intranasal corticosteroids may be more appropriate for allergic rhinitis in children 1
• Non-pharmacological approaches such as adequate hydration and humidification

Important Precautions

• Bromfed should be used with caution in patients with:

  • History of bronchial asthma
  • Narrow angle glaucoma
  • Gastrointestinal obstruction
  • Urinary bladder neck obstruction
  • Diabetes
  • Hypertension
  • Heart disease
  • Thyroid disease 2

• Drug interactions: Avoid concomitant use with MAO inhibitors and use caution with other CNS depressants 2

Conclusion

When considering treatment for nasal congestion or allergic symptoms in children, the risks of Bromfed (brompheniramine and pseudoephedrine) outweigh the benefits for children under 6 years of age. For older children, safer alternatives should be considered first, and if Bromfed is used, it should be with appropriate medical supervision and dosing.