Warning on Using Phenergan in Children Under Two
FDA Patient Safety News: Show #39, May 2005

The FDA and Wyeth have notified health care professionals that Phenergan tablets and suppositories are contraindicated in children under the age of two because the drug could cause fatal respiratory depression.

The labeling also warns practitioners to be cautious when using Phenergan in older children. It notes that respiratory depression can also occur in this age group, even when the dose has been calculated according to the child's weight. The risk is increased when Phenergan is used concomitantly with other drugs that may cause respiratory depression.

The labeling goes on to remind practitioners that antiemetics such as Phenergan are not recommended for treating uncomplicated vomiting in children. Another reason to avoid using Phenergan in children is that it can cause extrapyramidal symptoms that can be mistaken for the CNS signs of diseases such as encephalopathy or Reye's Syndrome.

Additional Information:

FDA MedWatch Safety Alert 2005 - Phenergan (promethazine hydrochloride).
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm152554.htm


FDA Patient Safety News is available at www.fda.gov/psn