Why is cough syrup not advisable in children?

Why Cough Syrup Is Not Advisable in Children

Cough syrups should not be used in children under 4 years of age because they lack proven efficacy, carry significant risk of toxicity including death, and offer no benefit over supportive care or honey (for children over 1 year). 1

Age-Based Contraindications

Children Under 4 Years

• The American Academy of Pediatrics and FDA explicitly recommend against using over-the-counter cough and cold medications in children under 4 years due to potential toxicity and lack of proven efficacy. 1
• Between 1969 and 2006, there were 54 deaths associated with decongestants and 69 deaths associated with antihistamines in children under 6 years, with 43 decongestant deaths occurring in infants under 1 year. 1
• Major manufacturers voluntarily removed cough and cold medications for children under 2 years from the OTC market in 2007 due to safety concerns. 1

Children 4-6 Years

• OTC cold medications should generally be avoided in this age group, as the FDA's advisory committees recommended against their use in children under 6 years. 1

Children 6 Years and Older

• May use OTC cold medications according to package directions, though benefits remain limited. 1
• FDA labeling for dextromethorphan specifically states "do not use" for children under 4 years. 2

Why These Medications Don't Work

Lack of Efficacy

• Controlled trials demonstrate that antihistamine-decongestant combination products are not effective for symptoms of upper respiratory tract infections in young children. 1
• OTC cough medications have little, if any, benefit in the symptomatic control of acute cough in children. 1
• Over-the-counter cough and cold medicines have not been shown to make cough less severe or resolve sooner. 3

Specific Medication Concerns

• Codeine-containing medications must be avoided in children due to potential serious side effects including respiratory distress. 3
• In 2018, the FDA altered labeling for prescription opioid cough medicines to limit their use to adults ≥18 years due to safety concerns. 1
• Beta-2 agonists (like salbutamol) have no evidence supporting their use in children with acute cough and no evidence of airflow obstruction. 1

Serious Safety Risks

Common Causes of Adverse Events

• Use of multiple cold/cough products containing the same ingredients leads to unintentional overdose. 1
• Medication errors from incorrect dosing are common, particularly in young children. 1
• A study found that 76% of mothers administered cough syrup at double the recommended dose to children under 2 years. 4

Specific Toxicity Concerns

• Decongestants have a narrow therapeutic window and risk of cardiovascular and CNS side effects, especially below age 1 year. 1
• Codeine carries risks of respiratory drive suppression, anaesthetic-induced anaphylaxis, and addiction, with metabolic response variability placing children at increased risk. 5
• Antihistamines are associated with adverse events when combined with other OTC ingredients and have minimal to no efficacy for cough relief. 3

What to Use Instead

First-Line Treatment

• The American Academy of Pediatrics recommends honey as the first-line treatment for cough in children over 1 year old, as it provides more relief for cough symptoms than no treatment, diphenhydramine, or placebo. 6, 3
• Honey is safer than codeine-containing medications and more effective than antihistamines. 6

Critical Safety Warning

• Never give honey to infants under 12 months of age due to risk of infant botulism. 6, 3

Supportive Care

• Most acute coughs are self-limiting viral infections requiring only supportive care. 3
• Environmental modifications include evaluating and addressing tobacco smoke exposure and other environmental pollutants. 3

Common Pitfalls to Avoid

• Do not prescribe OTC medications due to parental pressure despite lack of efficacy. 3
• Avoid assuming that cough always represents asthma and treating with bronchodilators without evidence of airflow obstruction. 1
• Do not use adult cough management approaches in pediatric patients. 3
• Always ask caregivers about use of over-the-counter combination medications to avoid overdose from multiple medications containing the same ingredient. 7

When to Re-Evaluate

• If cough persists beyond 2-4 weeks, the child should be re-evaluated for emergence of specific etiological pointers. 6, 3
• Consider medical evaluation if cough is accompanied by difficulty breathing, persistent fever, changes in mental status, or refusal to eat/drink. 6
• All children with chronic cough require thorough clinical review using pediatric-specific cough management protocols. 3