[e-drug] FDA: promethazine and fatal respiratory depression

["E-Drug" <e-drug@healthnet.org>]

E-DRUG: FDA: promethazine and fatal respiratory depression
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[This popular but not so safe promethazine (Phenergan (R)) is being overused a lot in Africa. Here a new warning from the USA FDA, contraindicating tablets and suppositories of promethazine in children under 2 years.

Promethazine elixer is still in the WHO Formulary 2004, and, although it does not provide a dosage schedule for children under 2 years, it does not warn about the dangers in small children. Porphyria is the only contraindication.

Time to ban promathazine syrup and drops in the the world as these are specifically targeted for infants?

WB]

FDA MedWatch: Phenergan (promethazine) contraindicated in
children < 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

---

Wyeth letter:

Dear Health Care Professional:

We are writing to make you aware of the latest information on labeling changes to the CONTRAINDICATIONS, WARNINGS/Use in Pediatric Patients, and
DOSAGE AND ADMINISTRATION sections of the prescribing information
for Phenergan (promethazine hydrochloride) Tablets and Suppositories.

Based on a review of adverse events for Phenergan in pediatric patients, the Food and Drug Administration has requested that the following changes, shown here underlined, be made to the product prescribing information.

CONTRAINDICATIONS

Phenergan Tablets and Suppositories are contraindicated for use in
pediatric patients less than two years of age.

WARNINGS
PHENERGAN SHOULD NOT BE USED IN PEDIATRIC
PATIENTS LESS THAN 2 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 2
YEARS OF AGE. A WIDE RANGE OF WEIGHT-BASED DOSES
OF PHENERGAN HAVE RESULTED IN RESPIRATORY
DEPRESSION IN THESE PATIENTS.
CAUTION SHOULD BE EXERCISED WHEN ADMINISTERING
PHENERGAN TO PEDIATRIC PATIENTS 2 YEARS OF AGE
AND OLDER. IT IS RECOMMENDED THAT THE LOWEST
EFFECTIVE DOSE OF PHENERGAN BE USED IN PEDIATRIC
PATIENTS 2 YEARS OF AGE AND OLDER AND
CONCOMITANT ADMINISTRATION OF OTHER DRUGS WITH
RESPIRATORY DEPRESSANT EFFECTS BE AVOIDED.

Wyeth Pharmaceuticals
500 Arcola Rd
Collegeville, PA
(800) 934-5556
Labeling Changes: Phenergan Tablets and Suppositories
January 4, 2005

WARNINGS
Use in Pediatric Patients
PHENERGAN TABLETS AND SUPPOSITORIES ARE
CONTRAINDICATED FOR USE IN PEDIATRIC PATIENTS LESS
THAN TWO YEARS OF AGE.
CAUTION SHOULD BE EXERCISED WHEN ADMINISTERING
PHENERGAN TABLETS AND SUPPOSITORIES TO PEDIATRIC
PATIENTS 2 YEARS OF AGE AND OLDER BECAUSE OF THE
POTENTIAL FOR FATAL RESPIRATORY DEPRESSION.
RESPIRATORY DEPRESSION AND APNEA, SOMETIMES
ASSOCIATED WITH DEATH, ARE STRONGLY ASSOCIATED
WITH PROMETHAZINE PRODUCTS AND ARE NOT DIRECTLY
RELATED TO INDIVIDUALIZED WEIGHT-BASED DOSING,
WHICH MIGHT OTHERWISE PERMIT SAFE
ADMINISTRATION. CONCOMITANT ADMINISTRATION OF
PROMETHAZINE PRODUCTS WITH OTHER RESPIRATORY
DEPRESSANTS HAS AN ASSOCIATION WITH RESPIRATORY
DEPRESSION, AND SOMETIMES DEATH, IN PEDIATRIC
PATIENTS.
ANTIEMETICS ARE NOT RECOMMENDED FOR TREATMENT
OF UNCOMPLICATED VOMITING IN PEDIATRIC PATIENTS,
AND THEIR USE SHOULD BE LIMITED TO PROLONGED
VOMITING OF KNOWN ETIOLOGY. THE EXTRAPYRAMIDAL
SYMPTOMS WHICH CAN OCCUR SECONDARY TO
PHENERGAN TABLETS AND SUPPOSITORIES
ADMINISTRATION MAY BE CONFUSED WITH THE CNS
SIGNS OF UNDIAGNOSED PRIMARY DISEASE, e.g.,
ENCEPHALOPATHY OR REYE&#8217;S SYNDROME. THE USE OF
PHENERGAN TABLETS AND SUPPOSITORIES SHOULD BE
AVOIDED IN PEDIATRIC PATIENTS WHOSE SIGNS AND
SYMPTOMS MAY SUGGEST REYE&#8217;S SYNDROME OR OTHER
HEPATIC DISEASES.
Labeling Changes: Phenergan Tablets and Suppositories
January 4, 2005

DOSAGE AND ADMINISTRATION
Phenergan Tablets and Phenergan Rectal Suppositories are
contraindicated for children under 2 years of age (see WARNINGS&#8211;
Black Box Warning and Use in Pediatric Patients).
Please see enclosed Prescribing Information.

If you require further information, please contact Global Medical
Communications at 1-800-934-5556.

Regards,

Joseph Camardo, MD
Senior Vice President
Global Medical Affairs