Why should infants not be given cough medicine or decongestant?

Why Infants Should Not Receive Cough Medicine or Decongestants

Infants and young children under 6 years of age should not be given over-the-counter cough medicines or decongestants because these medications have not been proven effective for symptom relief, and they carry significant risks of serious adverse events including death. 1, 2

Lack of Efficacy

• Controlled clinical trials have consistently demonstrated that antihistamine-decongestant combination products are not effective for treating symptoms of upper respiratory tract infections in young children. 1
• There is no evidence that OTC cough medications provide meaningful benefit in controlling acute cough in children. 2
• The therapeutic benefit that parents hope for simply does not exist in this age group, making any risk unacceptable. 1

Documented Mortality and Serious Adverse Events

The safety data are particularly alarming for the youngest children:

• Between 1969 and 2006, there were 54 deaths associated with decongestants in children under 6 years, with 43 of these deaths occurring in infants under 1 year of age. 1, 2, 3
• During the same period, 69 fatalities were associated with antihistamines in children under 6 years. 1, 2
• Three infants under 6 months died in 2005 alone, with cough and cold medications determined to be the underlying cause of death. 4
• An estimated 1,519 children under 2 years were treated in U.S. emergency departments during 2004-2005 for adverse events related to these medications. 4

Specific Toxicity Concerns

Decongestants

• Oral decongestants in infants and young children have been associated with agitated psychosis, ataxia, hallucinations, tachyarrhythmias, and death. 1
• Topical nasal decongestants have an extremely narrow margin between therapeutic and toxic doses in infants under 1 year, increasing risk for cardiovascular and central nervous system side effects. 3

Antihistamines and Cough Suppressants

• Preparations containing antihistamines and dextromethorphan have been associated with adverse events and reported deaths from toxicity. 1
• Codeine-containing medications should be avoided due to potential for serious side effects including respiratory distress. 1

Common Causes of Adverse Events

The documented deaths and serious events resulted from: 1, 4

• Use of multiple cold/cough products containing the same ingredients (leading to unintentional overdose)
• Medication dosing errors by caregivers
• Accidental exposures
• Intentional overdose

Regulatory Response

The severity of this issue prompted major regulatory action:

• In 2007, major manufacturers (Wyeth, Novartis, Prestige Brands, and Johnson & Johnson) voluntarily removed cough and cold medications for children under 2 years from the over-the-counter market. 1, 2
• The FDA's Nonprescription Drugs and Pediatric Advisory Committees recommended that OTC cough and cold medications no longer be used for children below 6 years of age. 1, 2
• The American Academy of Pediatrics and FDA recommend that children under 4 years should not use these medications due to potential toxicity and lack of proven efficacy. 2

Safe Alternatives for Symptom Management

Instead of medications, the following approaches are recommended:

• For children over 1 year with acute cough: Honey may offer more relief than no treatment, diphenhydramine, or placebo (honey should never be given to infants under 1 year due to botulism risk). 1, 2
• Conservative therapies: Nasal suctioning, humidification, and nasal saline are safe and should be recommended over cough/cold products. 5
• Parental education: Discussing environmental influences and addressing parental expectations and fears are valuable in managing cough in children. 1

Critical Pitfalls to Avoid

• Never assume that because a medication is available over-the-counter, it is safe for infants. 4, 6
• Always ask caregivers about use of over-the-counter combination medications to avoid overdose from multiple products containing the same ingredient. 4
• Do not prescribe these medications even at reduced doses—the dosages at which they can cause illness or death in children under 2 years are not known. 4
• Recognize that cough is often a protective mechanism, and suppressing it may not be beneficial even if it were safe. 7