Is it safe to give Bromfed DM (Brompheniramine and Dextromethorphan) to an 11-year-old child?

Bromfed DM Safety in 11-Year-Old Children

Bromfed DM is not recommended for children under 12 years of age due to safety concerns and lack of FDA approval for this age group. 1

Safety Concerns

• Bromfed DM contains brompheniramine (antihistamine), dextromethorphan (cough suppressant), and pseudoephedrine (decongestant), a combination that poses several safety concerns for children 1
• The FDA label specifically states that safety and effectiveness in pediatric patients below the age of 6 months have not been established, but does not provide explicit approval for use in children aged 6 months to 12 years 1
• Antihistamines like brompheniramine can cause significant central nervous system effects that vary from depression to stimulation, especially in children 1
• Some asthmatic children may experience adverse effects from brompheniramine, including decreased pulmonary function and worsening of asthma symptoms 2

Potential Adverse Effects

• Common adverse effects of Bromfed DM components in children include:
  • CNS effects: drowsiness, dizziness, excitation, hallucinations 1
  • Cardiovascular effects: tachycardia, hypertension, cardiac arrhythmias 1
  • Anticholinergic effects: dry mouth, urinary retention, blurred vision 1
• Overdose symptoms can be severe and include:
  • Seizures, which have been reported in children following ingestion of dextromethorphan 1
  • Ataxia, drowsiness, and fever 1
  • Potential for respiratory depression 1

Age-Appropriate Alternatives

• For children under 12 years of age, single-ingredient medications with established pediatric dosing are preferred over combination products like Bromfed DM 3
• When treating fever or pain in children, acetaminophen or ibuprofen are considered safe and effective options with established pediatric dosing 4
• For cough and cold symptoms in children, non-pharmacological approaches should be considered first, as many cough and cold medications have not been adequately studied in children 5

Important Considerations

• 50-90% of drugs used in children have never been adequately studied in pediatric populations, leading to concerns about safety and efficacy 3
• Off-label use of medications in children can lead to adverse events due to differences in pharmacokinetics and pharmacodynamics between children and adults 3
• Diphenhydramine (another antihistamine similar to brompheniramine) exposures in children have resulted in significant adverse events, with the majority occurring in children 2 to 4 years of age 5

Conclusion

Given the lack of FDA approval for use in children under 12 years, the potential for significant adverse effects, and the availability of safer alternatives, Bromfed DM should not be given to an 11-year-old child. Parents should consult with a healthcare provider for age-appropriate alternatives to manage specific symptoms.