Are antihistamines (antihistaminics) safe for use in children under 1 year?

Antihistamines Are Not Safe for Children Under 1 Year of Age

Antihistamines should not be used in children under 1 year of age due to significant safety concerns including reported fatalities and lack of established efficacy. 1, 2 First-generation antihistamines in particular pose serious risks to infants, with 41 reported fatalities in children under 2 years associated with diphenhydramine, brompheniramine, and chlorpheniramine between 1969 and 2006. 1

Safety Concerns with Antihistamines in Infants

First-Generation Antihistamines

• FDA-approved diphenhydramine labeling explicitly states "Do not use" for children under 6 years of age 2
• Significant mortality risk documented with first-generation antihistamines:
  • 69 fatalities reported in children under 6 years (41 under age 2) associated with diphenhydramine, brompheniramine, and chlorpheniramine 1
  • Common causes of adverse events include overdose, medication errors, and accidental exposures 1
• Side effects particularly concerning in infants:
  • CNS depression and sedation
  • Paradoxical excitation
  • Anticholinergic effects (urinary retention, mucosal dryness)
  • Cardiovascular effects

Second-Generation Antihistamines

• While second-generation antihistamines have better safety profiles than first-generation agents, most are not approved for children under 2 years 3, 4
• Limited safety data exists for infants under 1 year 3
• Even second-generation antihistamines can cause serious adverse reactions in children, including:
  • Seizures (levocetirizine) 5
  • Severe skin reactions 5

Regulatory and Expert Guidance

• In 2007, major pharmaceutical companies voluntarily removed cough and cold medications (including antihistamines) for children under 2 years from the OTC market 1
• FDA's Nonprescription Drugs and Pediatric Advisory Committees recommended against using OTC cough and cold medications in children under 6 years 1
• Many antihistamines are prescribed off-label in children under 2 years, where safety data is most lacking 3

Age-Specific Recommendations for Antihistamines

Under 1 year:

• Antihistamines should not be used 1, 2
• No antihistamines are FDA-approved for this age group
• High risk of adverse effects including potential fatality

Ages 1-2 years:

• Limited options with established safety data
• Some second-generation antihistamines (cetirizine, loratadine) may be used under medical supervision 6, 4
• First-generation antihistamines should be avoided

Ages 2-6 years:

• Second-generation antihistamines preferred when necessary 1, 7
• Cetirizine: 2.5 mg once or twice daily 1
• Loratadine: 5 mg daily 1

Alternative Approaches for Infants with Allergic Symptoms

For infants under 1 year with allergic symptoms:

• Identify and avoid triggers
• Saline nasal irrigation for nasal congestion
• Maintain adequate hydration
• Humidification of air
• Consult with pediatric allergist for severe cases

Key Pitfalls to Avoid

1. Do not use OTC antihistamine products in infants - these are explicitly contraindicated for children under 6 years 2
2. Do not assume second-generation antihistamines are completely safe - while they have better safety profiles, they still carry risks in very young children 5
3. Do not use antihistamines as sedatives for infants - this practice is dangerous and explicitly warned against 2
4. Do not combine multiple products containing antihistamines - this increases risk of overdose 1

In conclusion, the risks of using antihistamines in children under 1 year of age outweigh any potential benefits. The documented fatalities and serious adverse events, along with explicit FDA labeling against such use, strongly support avoiding these medications in infants.