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 < 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

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