Case Evaluation

Promethazine HC1: Breathing Problems in Children Using Promethazine

April 25, 2006: FDA Alert - Breathing Problems in Children Using Promethazine

The FDA issued an alert notifying healthcare professionals and the public that promethazine HCl should not be given to children less than two years old, because of possible breathing problems. This warning pertains to promethazine in any form: syrups, suppositories, tablets, or injectables. The FDA has received reports of breathing problems (some fatal) when promethazine was administered to children less than two years old. Parents and caregivers should get a healthcare professional's advice about giving promethazine in any form to children age two and older. The labeling on all promethazine HCl products (both brand name and generic) has been changed to reflect these strengthened warnings.

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