FDA MedWatch: Phenergan (promethazine) contraindicated in children < 2 y.o due to fa

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FDA MedWatch: Phenergan (promethazine) contraindicated in childre n

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

FDA and Wyeth notified healthcare professionals of revisions to the

CONTRAINDICATIONS, WARNINGS/Use in Pediatric Patients, and DOSAGE AND

ADMINISTRATION sections of the prescribing information for Phenergan.

Phenergan is contraindicated for use in pediatric patients less than two

years of age because of the potential for fatal respiratory depression.

Postmarketing cases of respiratory depression including fatalities, have

been reported with use of Phenergan in pediatric patients less than two

years of age. Caution should also be exercised when administering Phenergan

to pediatric patients two years of age and older.

Read the complete MedWatch 2005 Safety Summary, with links to the Dear

Healthcare Professional letter and revised label, at:

www.fda.gov/medwatch/SAFETY/2005/safety05.htm#phenergan

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