Fexofenadine hydrochloride has a good safety profile in treating allergic rhinitis in children 6-24 months of age, researchers report in the December issue of the Annals of Allergy, Asthma, and Immunology.
“Allergic rhinitis (AR) is a common chronic condition and is estimated to affect up to 40% of children in some countries,” Dr. Frank C. Hampel, of Central Texas Health Research, New Braunfels, Texas, and colleagues write. “Antihistamines are an established first-line treatment for allergic rhinitis and are widely prescribed in infants for allergic symptoms.”
The researchers assessed the safety and tolerability of fexofenadine hydrochloride in children aged 6 months to 2 years in two studies, both multicenter, randomized, placebo-controlled, parallel-group trials. The mean duration of treatment was 8 days.
Altogether, 393 subjects were randomized to twice-daily fexofenadine hydrochloride, 15 or 30 mg, or placebo. All but one received treatment: fexofenadine 15 mg (n = 85); fexofenadine 30 mg (n = 108); and placebo (n = 199). Overall, 265 participants completed the study per protocol.
The incidence of treatment-emergent adverse events (TEAEs) was comparable between groups in the combined population — 48.2% in the placebo group, 40.0% in the fexofenadine 15 mg group, and 35.2% in the fexofenadine 30 mg group.
The most common TEAE was vomiting. Most TEAEs were unrelated to study medication. The TEAEs that were possibly related to study medication were mild to moderate in intensity.
“No clinical differences were observed between the fexofenadine treatment groups and placebo for any vital sign or any ECG variable,” Dr. Hampel and colleagues found. “No clinically meaningful differences were observed between the fexofenadine treatment groups and placebo for any of the physical examination results.”
They add: “To our knowledge, this is the first report to establish the safety and tolerability of fexofenadine at clinically relevant doses in children between 6 months and 2 years.”