Safety of antihistamines in children: need for approval of new second-generation antihistamines for young children in Japan

Abstract

In Japan, loratadine, fexofenadine, cetirizine and epinastine are currently approved for paediatric use. However, none of these drugs is officially approved for use in children aged under 2 years, and therefore older second-generation antihistamines such as ketotifen and oxatomide are sometimes prescribed for these patients. Because ketotifen and oxatomide have relatively strong sedative effects, one should be cautious when using these antihistamines in young children. In fact, there are reports describing the development of West syndrome, an intractable epilepsy, in 4-month-old infants taking these drugs. Recent clinical trials in Japanese children with allergic rhinitis have shown no serious adverse effects associated with several new second-generation antihistamines, supporting previous overseas reports. New second-generation antihistamines should be approved in the near future for young children in Japan.