Can cough medicines be given to neonates?

Cough Medicines in Neonates

Over-the-counter cough and cold medications should NOT be given to neonates (infants <1 month) or any child under 2 years of age due to lack of proven efficacy, absence of FDA-approved dosing for this age group, and documented risk of serious adverse events including death. 1

Evidence Against Use

Safety Concerns

• Three infant deaths (all <6 months) were directly attributed to cough and cold medications in 2005, with medical examiners determining these medications as the underlying cause of death 1
• An estimated 1,519 children aged <2 years were treated in U.S. emergency departments during 2004-2005 for adverse events (including overdoses) associated with cough and cold medications 1
• The dosages at which these medications can cause illness or death in children <2 years are unknown 1

Lack of Efficacy

• Systematic reviews found little to no support for the effectiveness of cough and cold medicines for acute cough or common cold in children 2
• These medications lack proven efficacy, can delay diagnosis of serious underlying conditions, and have caused complications and deaths 3

Regulatory Position

• No FDA-approved dosing recommendations exist for cough and cold medications in children <2 years 1
• International regulatory authorities have advised against use or are considering restrictions on these products in young children 2

Clinical Approach to Neonatal Cough

When Antibiotics ARE Indicated

If the neonate has pertussis (whooping cough):

• Azithromycin is the first-line agent: 10 mg/kg per day for 5 days 4, 5
• Azithromycin is preferred over erythromycin due to significantly lower risk of infantile hypertrophic pyloric stenosis (IHPS) 4
• Erythromycin should be avoided in neonates if possible due to association with IHPS 6, 4
• Clarithromycin is not recommended in infants <1 month due to unknown risk of IHPS 6

Supportive Care Only

For non-pertussis cough in neonates:

• Do NOT use cough suppressants (dextromethorphan, codeine) - no proven benefit and potentially harmful 5
• Do NOT use antihistamines, corticosteroids, or β-agonists - no demonstrated benefit in controlling cough 4, 5
• Position infant upright or semi-upright during coughing episodes 5
• Use cool-mist humidifier to keep airways moist (though evidence is limited) 5
• Minimize environmental irritants (smoke, strong odors) 5

Critical Red Flags Requiring Immediate Evaluation

• Apneic episodes (breathing pauses >10-15 seconds) 5
• Respiratory distress (grunting, nasal flaring, retractions) 5
• Oxygen desaturation below 90-92% 5
• Inability to feed or signs of dehydration 5
• Any change in mental status or lethargy 5

Key Pitfalls to Avoid

• Never recommend over-the-counter cough medicines to parents of neonates or infants <2 years - this is contraindicated 1
• Many cases of toxicity result from therapeutic error (well-meaning parents giving inappropriate doses) 2
• Diphenhydramine and codeine are particularly associated with severe adverse effects 2
• Parents may inadvertently overdose by giving multiple products containing the same active ingredient 1