Safety of Cough Patches in Young Children
Cough patches should NOT be used in a 1 year 7 months old girl, as over-the-counter cough and cold medications (including topical preparations) are not recommended for children under 2 years of age due to lack of proven efficacy and significant safety concerns, including reported deaths. 1, 2, 3
Why Cough Patches Are Not Safe for This Age Group
Regulatory Position and Safety Data
The FDA does not recommend the use of cough and cold products that contain antihistamines or decongestants in children younger than 2 years. 3
Between 1969-2006, there were 54 fatalities associated with decongestants in children under 6 years, with 43 deaths occurring in infants under 1 year. 2
During the same period, 69 fatalities were associated with antihistamines in children under 6 years, with 41 deaths reported in children under 2 years. 2
In 2007, major pharmaceutical companies voluntarily removed cough and cold medications for children under 2 years from the OTC market. 2
The FDA's advisory committees recommended against using OTC cough and cold medications in children under 6 years. 2
Lack of Efficacy
OTC cough and cold medications have not been established as effective for symptomatic treatment of upper respiratory tract infections in children younger than 6 years. 2
Data surrounding the safety and efficacy of cough and cold medications in patients younger than 6 years are lacking. 3
These medications have been shown to lack efficacy, delay more serious underlying diagnoses, and can cause complications and sometimes death. 4
What Should Be Done Instead
Appropriate Supportive Care
Provide information to families about managing fever, preventing dehydration, and identifying signs of deterioration. 2
Use antipyretics and analgesics to keep the child comfortable and help with coughing. 2
Ensure adequate hydration, which is crucial to help thin secretions. 2
Gentle suctioning of the nostrils may help improve breathing in children with nasal congestion. 2
When to Evaluate Further
If the cough persists beyond 3-4 weeks, this transitions from acute to "prolonged acute cough" and warrants further evaluation. 2
At 4 weeks duration, the cough becomes "chronic" and requires systematic evaluation using pediatric-specific algorithms. 1
Look for specific cough pointers that indicate serious underlying disease, such as coughing with feeding, digital clubbing, failure to thrive, or focal chest findings. 5
When to Seek Medical Attention Immediately
Parents should seek medical attention if the child exhibits respiratory rate >70 breaths/min. 2
Difficulty breathing, grunting, or cyanosis are signs that require immediate medical attention. 2
Oxygen saturation <92% (if measured) is a critical indicator for seeking medical help. 2
Not feeding well or signs of dehydration are warning signs that necessitate medical evaluation. 2
Common Pitfalls to Avoid
Never use topical decongestants in children under 1 year due to narrow margin between therapeutic and toxic doses, increasing risk for cardiovascular and CNS side effects. 2
Do not empirically treat for asthma, GERD, or upper airway cough syndrome without specific clinical features supporting these diagnoses. 5
The dosages at which cough and cold medications can cause illness or death in children aged <2 years are not known. 6
Clinicians should always ask caregivers about their use of over-the-counter combination medications to avoid overdose in children from multiple medications that contain the same ingredient. 6