FDA MedWatch: Phenergan (promethazine) contraindicated in childre n < 2 y.o due to fatal respiratory depression
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