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Correspondence
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Volume 352:2653 June 23, 2005 Number 25
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Boxed Warning Added to Promethazine Labeling for Pediatric Use

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To the Editor: In late 2004, a "boxed warning" was added to the labeling for promethazine hydrochloride (Phenergan), including a contraindication for use in children less than two years of age and a strengthened warning with regard to use in children two 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, serious and often life-threatening adverse events, including respiratory depression, oversedation, agitation, hallucinations, seizures, and dystonic reactions, have been reported with promethazine use in children.1,2 The occurrence of these adverse . . . [Full Text of this Article]


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