Antihistamine Use in Children Under 2 Years Old
Antihistamines should generally be avoided in children under 2 years of age due to safety concerns, with no over-the-counter antihistamines recommended for this age group. 1, 2
Safety Concerns and Guidelines
- The FDA and pediatric advisory committees recommend against using OTC cough and cold medications (including antihistamines) in children under 6 years of age due to significant safety concerns 1
- FDA-approved labeling for diphenhydramine (a first-generation antihistamine) explicitly states "Do not use" for children under 6 years of age 2
- Between 1969 and 2006, there were 69 fatalities associated with antihistamines in children under 6 years, with 41 reported in children under 2 years 1
- Common causes of serious adverse events include:
- Drug overdose
- Medication errors
- Accidental exposures
- Use of multiple cold/cough products simultaneously 1
First vs. Second Generation Antihistamines
First-Generation Antihistamines
- Not recommended for children under 2 years due to:
Second-Generation Antihistamines
- Have better safety profiles than first-generation antihistamines 5, 3
- Some second-generation antihistamines (cetirizine, desloratadine, fexofenadine, levocetirizine, and loratadine) have been shown to be well-tolerated in young children 1
- However, most are not FDA-approved for children under 2 years 6
Specific Antihistamine Options
When antihistamines must be used in children under 2 years (in exceptional circumstances and under medical supervision):
- Cetirizine and loratadine are the only second-generation antihistamines approved for children under 5 years in some countries 7
- Dosing must be carefully adjusted based on:
- Age and weight
- Renal function (cetirizine dose should be halved in moderate renal impairment) 8
- Hepatic function
Common Pitfalls to Avoid
- Using OTC antihistamines without medical supervision in children under 2 years
- Administering adult doses to young children
- Combining multiple products containing antihistamines
- Using first-generation antihistamines when second-generation options are available
- Not recognizing signs of overdose including:
- Excessive sedation
- Paradoxical excitation
- Respiratory depression
- Cardiovascular effects
When Medical Consultation is Required
- Always consult a physician before administering any antihistamine to a child under 2 years 8
- Seek immediate medical attention for any adverse reactions
- Emergency care is needed for suspected overdose
In summary, antihistamines should generally be avoided in children under 2 years of age unless specifically prescribed by a physician, with second-generation antihistamines preferred when treatment is necessary due to their better safety profile.