The FDA has notified health care professionals and patients that serious and sometimes fatal breathing problems have occurred in children younger than two years of age who were given the anti-histamine agent promethazine HCl (e.g., Phenergan medication, Wyeth). Parents and care-givers should obtain a doctor’s advice about giving promethazine in any form to children age two and older.

The labeling on all canadian promethazine brand-name and generic products has been changed to reflect these strengthened warnings.

A black-box warning is now required for the injectable form of promethazine drug , a sedative and an antinausea/antiemetic agent. The warning highlights the risk of serious tissue injury when the drug is administered incorrectly.

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