What is the safety and efficacy of dextromethorphan in pediatric (children) patients?

From the Guidelines

Dextromethorphan should not be used in children under 4 years of age due to the risk of adverse events, including reported death from toxicity, as stated in the 2020 Chest guideline and expert panel report 1. When considering the safety and efficacy of dextromethorphan in pediatric patients, it is crucial to weigh the potential benefits against the risks. The most recent and highest quality study, published in 2020 in the journal Chest, highlights the lack of efficacy and potential morbidity and mortality of over-the-counter (OTC) medications, including dextromethorphan, in young children 1.

Key Considerations

• The American Academy of Pediatrics has advised against the use of codeine and dextromethorphan for treating any type of cough, citing significant morbidity and mortality associated with their use 1.
• A systematic review concluded that OTC cough medications, including those containing dextromethorphan, have little to no benefit in the symptomatic control of acute cough in children and are associated with adverse events 1.
• Honey may offer more relief for cough symptoms than no treatment, diphenhydramine, or placebo, but it is not better than dextromethorphan, according to an ungraded consensus-based statement in the 2020 Chest guideline 1.

Recommendations

• For children 4 years of age and older, dextromethorphan may be considered for the treatment of acute cough, but with careful consideration of the potential risks and benefits.
• Parents should be advised to use measuring devices that come with the medication rather than household spoons for accurate dosing.
• Dextromethorphan should be avoided in children taking MAO inhibitors or SSRIs due to the risk of serotonin syndrome, and caution is needed in patients with asthma as cough suppression may worsen respiratory status.
• If cough persists beyond a week, worsens, or is accompanied by high fever, rash, or persistent headache, medical evaluation is necessary.

From the FDA Drug Label

Directions • shake bottle well before use • measure only with dosing cup provided • do not use dosing cup with other products • dose as follows or as directed by doctor adults and children 12 years of age and over 10 mL every 12 hours, not to exceed 20 mL in 24 hours children 6 to under 12 years of age 5 mL every 12 hours, not to exceed 10 mL in 24 hours children 4 to under 6 years of age 2.5 mL every 12 hours, not to exceed 5 mL in 24 hours children under 4 years of age do not use

The safety and efficacy of dextromethorphan in pediatric patients is established for children 4 years of age and older, with specific dosing instructions provided.

• For children 12 years of age and over, the dose is 10 mL every 12 hours, not to exceed 20 mL in 24 hours.
• For children 6 to under 12 years of age, the dose is 5 mL every 12 hours, not to exceed 10 mL in 24 hours.
• For children 4 to under 6 years of age, the dose is 2.5 mL every 12 hours, not to exceed 5 mL in 24 hours. However, for children under 4 years of age, the label states do not use, indicating no established safety and efficacy in this age group 2.

From the Research

Safety and Efficacy of Dextromethorphan in Pediatric Patients

• The safety and efficacy of dextromethorphan in pediatric patients have been evaluated in several studies 3, 4, 5, 6, 7.
• A study published in 2018 found that honey may have a similar effect as dextromethorphan in reducing cough frequency in children, with low-certainty evidence 3.
• Another study published in 2010 found that honey had a more alleviating effect on upper respiratory infections-induced cough compared to dextromethorphan and diphenhydramine in children aged 24-60 months 4.
• The American Academy of Pediatrics Committee on Drugs noted in 1997 that numerous prescription and nonprescription medications, including dextromethorphan, are available for suppression of cough in children, but education is needed about the lack of proven antitussive effects and potential risks of these products 5.
• A retrospective case series published in 2017 found that adverse events associated with dextromethorphan in children under 12 years old were predominantly associated with overdose, affecting the central nervous and autonomic systems 6.
• A Cochrane review published in 2014 found that honey may be better than 'no treatment' and placebo for symptomatic relief of cough in children, but it is not better than dextromethorphan, with moderate quality evidence 7.

Adverse Events

• Adverse events associated with dextromethorphan in pediatric patients include central nervous system symptoms such as ataxia, autonomic symptoms such as tachycardia, and gastrointestinal symptoms 3, 6, 7.
• A study published in 2018 found that adverse events including nervousness, insomnia, and hyperactivity were experienced by 9.3% of children in the honey group and 2.7% of children in the dextromethorphan group, with low-certainty evidence 3.
• Another study published in 2014 found that mild reactions such as nervousness, insomnia, and hyperactivity were experienced by 9.3% of children in the honey group and 2.7% of children in the dextromethorphan group, with no significant difference between the two groups 7.

Comparison with Other Treatments

• A study published in 2018 found that honey may be better than diphenhydramine in reducing cough frequency in children, with low-certainty evidence 3.
• Another study published in 2010 found that honey had a more alleviating effect on upper respiratory infections-induced cough compared to dextromethorphan and diphenhydramine in children aged 24-60 months 4.
• A Cochrane review published in 2014 found that honey may be better than 'no treatment' and placebo for symptomatic relief of cough in children, but it is not better than dextromethorphan, with moderate quality evidence 7.