Phenergan (promethazine) contraindicated
in children less than 2 years old 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