To the Editor: In late 2004, a "boxed warning" was added tothe labeling for promethazine hydrochloride (Phenergan), includinga contraindication for use in children less than two years ofage and a strengthened warning with regard to use in childrentwo years of age or older. We describe the basis for this action.
Promethazine is widely used in children as an antihistamine,antiemetic, and sedative. Since its approval in 1951, seriousand often life-threatening adverse events, including respiratorydepression, oversedation, agitation, hallucinations, seizures,and dystonic reactions, have been reported with promethazineuse in children.1,2 The occurrence of these adverse . . . [Full Text of this Article]
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