Is Polytussin (dextromethorphan) safe for patients under 6 years old?

Polytussin (Dextromethorphan) Safety in Children Under 6 Years

Polytussin and other over-the-counter cough and cold medications containing dextromethorphan should NOT be used in children under 6 years of age due to lack of proven efficacy and potential for serious adverse events including toxicity and death.

Regulatory Position and Safety Concerns

• The FDA does not recommend the use of cough and cold products containing antihistamines or decongestants in children younger than 2 years, and 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

• 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

• Between 1969 and 2006, there were multiple fatalities associated with decongestants and antihistamines in children under 6 years, with 43 of 54 decongestant-related deaths occurring in infants below age 1 year 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 Gap

• Data surrounding the safety and efficacy of cough and cold medications in patients younger than 6 years are lacking 2

• Controlled trials have shown that antihistamine-decongestant combination products are not effective for symptoms of upper respiratory tract infections in young children 1

• While dextromethorphan has been shown effective in children aged 6-11 years with objective reductions in cough frequency of 21-25% 3, no such evidence exists for younger children

Key Clinical Pitfalls to Avoid

• Do not recommend dextromethorphan-containing products for any child under 6 years of age, regardless of formulation or dose 1, 2

• Parents may inadvertently overdose children by using multiple cold/cough products simultaneously, each containing the same active ingredients 1

• Even if parents request these medications, explain that lack of proven benefit combined with documented risk of serious adverse events makes their use inappropriate 1

Alternative Management

• For children under 6 years with cough, focus on supportive care and non-pharmacologic interventions rather than OTC cough suppressants 2

• If cough is due to pertussis, appropriate antibiotic therapy (azithromycin for infants <6 months) is indicated rather than cough suppressants 4