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FDA OKs Clarinex Syrup for Young Children

Only Prescription Nondrowsy Antihistamine Syrup Approved for Infants, Toddlers

By Jeanie Lerche Davis
WebMD Health News

Sept. 3, 2004 -- The FDA has approved Clarinex syrup for the relief of allergy symptoms and itching due to hives in children as young as 6 months old. This is the only prescription nondrowsy antihistamine syrup on the market for very young children.

Specifically, Clarinex syrup has been approved for relief of symptoms associated with seasonal outdoor allergies in children aged 2 and older. Children 6 months and older can take Clarinex syrup for indoor allergies and to relieve itching due to hives.

Clarinex Syrup Approved for Children

The FDA based its approval on results from three studies involving 246 children between 6 months and 11 years of age. All had a history of indoor and outdoor allergies or hives of unknown cause.

In these trials, the adverse events were the same among children in the study taking Clarinex syrup as those children not taking the syrup. The most frequently seen side effects in children 6 months to 5 years old included: upper respiratory tract infection (sneezing, runny nose), diarrhea, fever, urinary tract infection, chicken pox, irritability, and coughing.

Clarinex syrup, which is manufactured by Schering-Plough Corporation, is expected to be available during the first half of 2005.

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