FDAnews Drug Daily Bulletin

FDA ISSUES WARNING ABOUT USE OF PROMETHAZINE HCI IN YOUNG CHILDREN

May 5, 2006
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The FDA has announced that medications containing promethazine hydrochloride (HCI) should not be given to children under the age of 2 due to reported fatalities association with the drug.

The FDA's warning states that "cases of respiratory depression including fatalities" have been reported in children less than 2 who have been given any product containing promethazine HCI. In addition, the FDA warns that caution should be used when giving those drugs to children over the age of two.

The warning covers all forms of medications containing promethazine HCI, including syrups, suppositories, injectables and tablets. Labels on brand and generic drugs have been changed to reflect this information, the FDA said. Wyeth Pharmaceuticals, which markets tablets and suppositories containing promethazine HCI under the name Promethazine also sent a letter to healthcare professions to alert them to the labeling change.

The FDA has received reports of 29 cases of respiratory depression, including seven deaths, associated with these drugs.