Clarinex syrup approved for children

Journal of Drugs in Dermatology, Nov-Dec, 2004

The FDA has approved Clarinex syrup for the relief of seasonal outdoor allergy symptoms in children aged 2 and older as well as relief of indoor allergies and urticaria in infants aged six months and older. This is the only non-sedating prescription antihistamine syrup on the market for use in infants and young 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 the trials, there was no difference in adverse events seen in children taking Clarinex syrup when compared to children not taking the syrup. The most frequently seen side effects in children aged six months to five years 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.