No more promethazine in kids under two, warns FDA

May 1, 2006

An FDA alert has been issued to warn practitioners that allproducts containing promethazine HCl are now contraindicated inchildren younger than two years of age. The labeling change comesafter the agency received reports of respiratory depression anddeath following use of the drug by children in this age group.

An FDA alert has been issued to warn practitioners that all products containing promethazine HCl are now contraindicated in children younger than two years of age. The labeling change comes after the agency received reports of respiratory depression and death following use of the drug by children in this age group. In addition, the alert warns that caution should be used when administering promethazine HCl medications to pediatric patients two years of age and older. The warning was issued for all brands and formulations, including syrups, tablets, injectables, and suppositories.

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