Is chlorphenamine (antihistamine) recommended for use in infants 15 months old?

Chlorphenamine Use in 15-Month-Old Infants

Chlorphenamine is not recommended for use in infants aged 15 months due to safety concerns and FDA labeling that specifically contraindicates its use in children under 6 years of age. 1

Safety Concerns in Young Children

The FDA drug label for chlorphenamine clearly states that it should not be used in children under 6 years of age 1. This restriction is based on significant safety concerns:

• First-generation antihistamines like chlorphenamine have a higher risk of adverse effects in young children due to their non-selective action on both peripheral and central H1 receptors 2
• Serious adverse events have been reported with chlorphenamine use in young children, including:
  • Convulsions and coma 3
  • Toxic epidermal necrolysis (significant association with a reporting odds ratio of 7.29) 4
  • Sedation, which appears more prevalent in the 2-5 year age group 5

Regulatory Guidance and Expert Recommendations

The British Journal of Dermatology guidelines specifically address antihistamine use in children and note that dosing and age restrictions vary for younger children, recommending that relevant data sheets be consulted before prescribing 6. The FDA labeling provides clear guidance against using chlorphenamine in children under 6 years 1.

Additionally, a comprehensive review of cough and cold medications containing antihistamines found:

• The FDA's Nonprescription Drugs and Pediatric Advisory Committees recommended that OTC medications used to treat cough and cold should not be used for children below 6 years of age 6
• Concerns about potential toxicity of these medications led to voluntary removal of cough and cold medications for children under age 2 years from the OTC market 6

Alternative Options

For infants requiring antihistamine therapy, second-generation antihistamines have been shown to be safer alternatives:

• Second-generation antihistamines such as cetirizine, desloratadine, fexofenadine, levocetirizine, and loratadine have been shown to be well tolerated and have a very good safety profile in young children 6
• These medications are more selective for peripheral H1 receptors, resulting in fewer adverse effects 2

Common Pitfalls to Avoid

1. Using adult medications in children without proper guidance: Many antihistamines are prescribed off-label in children younger than 2 years, where safety data is most lacking 2

2. Ignoring FDA warnings: The FDA has specifically warned against using chlorphenamine in children under 6 years 1

3. Overlooking sedation risk: First-generation antihistamines like chlorphenamine have significant sedative effects that can be more pronounced in young children 5

4. Failing to consider alternatives: Second-generation antihistamines have better safety profiles in young children and should be considered when antihistamine therapy is necessary 6

In conclusion, based on current FDA labeling and safety evidence, chlorphenamine should not be used in 15-month-old infants. If antihistamine therapy is required, consultation with a pediatrician about age-appropriate second-generation antihistamines would be more appropriate.