Is cetirizine (antihistamine) safe for infants under 12 months of age?

From the Guidelines

Cetirizine is not recommended for infants under 12 months of age due to the potential risk of side effects and the lack of conclusive evidence supporting its safety and efficacy in this age group. The FDA has approved cetirizine for children 6 months and older, but many pediatricians and medication guidelines advise against its use in infants under 12 months unless specifically prescribed by a doctor 1. This caution is due to the immature metabolic systems of babies, which can process medications differently than older children, potentially increasing the risk of side effects. Additionally, determining the cause of symptoms in infants can be challenging, and using antihistamines might mask important symptoms.

Some studies have examined the use of cetirizine in older infants, such as the Early Treatment of the Atopic Child (ETAC) trial, which found that cetirizine-treated patients had less urticaria, but no statistically significant improvement in overall AD control 1. However, these studies do not provide conclusive evidence to support the use of cetirizine in infants under 12 months. Other studies have reported sedative properties associated with cetirizine, particularly at higher doses 1.

Given the potential risks and lack of conclusive evidence, it is recommended that parents consult with a pediatrician first if their baby is experiencing allergy-like symptoms. The pediatrician can properly diagnose the condition and recommend appropriate treatment, which might include non-medication approaches or, if necessary, a carefully monitored prescription of cetirizine with specific dosing instructions for the baby's particular situation. Key considerations include:

• The baby's age and weight
• The severity of symptoms
• The potential risks and benefits of treatment
• Alternative treatment options, such as non-medication approaches or other medications.

From the Research

Safety of Cetirizine in Infants Under 12 Months

• The safety of cetirizine in infants under 12 months of age has been evaluated in several studies 2, 3, 4.
• A study published in 2003 found that cetirizine was safe and well-tolerated in infants aged 6-11 months, with no differences in adverse events or sleep-related disturbances compared to placebo 3.
• Another study published in 1999 found that cetirizine was safe for long-term use in children with atopic dermatitis, with no clinically relevant differences in safety outcomes compared to placebo 4.
• The study published in 2004 found that cetirizine was effective and well-tolerated in pediatric patients, including those under 12 months of age, with a favorable efficacy and tolerability profile 2.

Efficacy of Cetirizine in Infants Under 12 Months

• While there is limited data on the efficacy of cetirizine in infants under 12 months of age, studies suggest that it may be effective in reducing symptoms of allergic disorders in this age group 2, 3.
• A study published in 2003 found that cetirizine was effective in reducing symptoms of allergic disorders in infants aged 6-11 months, although the study was primarily designed to evaluate safety 3.

Comparison to Other Antihistamines

• Cetirizine has been compared to other antihistamines, including levocetirizine, in terms of safety and efficacy in children 5.
• Levocetirizine has been shown to be safe and effective in children aged 6 months to 12 years, although cetirizine has a more established safety profile in infants under 12 months of age 5.