Is Bromfed DM (dextromethorphan and pseudoephedrine) suitable for children?

Bromfed DM Is Not Recommended for Children Under 6 Years of Age

Bromfed DM (containing dextromethorphan and pseudoephedrine) should not be used in children under 6 years of age due to safety concerns including potential serious adverse effects such as agitated psychosis, ataxia, hallucinations, and even death. 1, 2, 3

Safety Concerns with Bromfed DM Components

Pseudoephedrine (Decongestant)

• FDA labeling clearly states pseudoephedrine should not be used in children under 6 years 3
• The 2008 rhinitis practice parameter guidelines specifically warn that oral decongestants in infants and young children have been associated with:
  • Agitated psychosis
  • Ataxia
  • Hallucinations
  • Death
  • Tachyarrhythmias
  • Insomnia
  • Hyperactivity 1

Dextromethorphan (Cough Suppressant)

• FDA labeling prohibits use in children under 4 years 2
• Associated with adverse events in pediatric populations, particularly when overdosed:
  • Central nervous system effects (ataxia)
  • Autonomic symptoms (tachycardia)
  • Urticarial rash/flushing
  • Dystonia 4

Regulatory Actions and Guidelines

The CHEST guidelines (2020) highlight that:

• FDA has issued warnings against using OTC cough medications in young children
• Manufacturers voluntarily relabeled OTC products with "do not use in children under 4 years of age"
• In 2018, FDA restricted prescription opioid cough medicines to adults ≥18 years 1

Age-Specific Recommendations

For children 6 years and older:

• Pseudoephedrine may be used with caution in children 6-11 years (1 tablet every 4-6 hours, maximum 4 tablets in 24 hours) 3
• Dextromethorphan dosing for children 6-12 years: 5 mL every 12 hours, not exceeding 10 mL in 24 hours 2

For children under 6 years:

• Both components are contraindicated by FDA labeling and clinical guidelines 2, 3
• A case report documented serious adverse events (hyperirritability, psychosis, and ataxia) in a 2-year-old child who received a pseudoephedrine/dextromethorphan combination 5

Common Pitfalls in Pediatric OTC Medication Use

1. Dosing errors: Parents may incorrectly measure or administer doses, leading to toxicity
2. Multiple product use: Using multiple products containing similar ingredients can lead to overdose
3. Misperception of safety: Assuming OTC medications are always safe because they're available without prescription
4. Abuse potential: Dextromethorphan has abuse potential, especially among adolescents 6

Alternative Approaches for Symptom Management

For children with cough and cold symptoms:

• Honey may offer more relief for cough symptoms than diphenhydramine or placebo in children (though not for infants under 1 year due to botulism risk) 1
• Adequate hydration and humidification of air
• Saline nasal drops/spray for congestion

When evaluating a child with respiratory symptoms requiring treatment, the underlying cause should be identified and treated specifically rather than using symptomatic medications with potential risks.