Wyeth has added a black box warning regarding the use of promethazine (Phenergan®) tablets and suppositories in pediatric patients less than two years of age. The reason give is the potential for fatal respiratory depression. The use of promethazine in children less than two is also listed in the Contraindications section of the package insert. According to the company, there was not a recent increase in the number of cases of fatal respiratory depression that prompted this warning. A representative of Wyeth said that the warning resulted from a review of the post-marketing adverse event reports. The company will not give out more specific information about the case reports such as the ages of the patients, the dose of the medication given, or other medications the patient might have been receiving. Company representatives direct more specific questions to the FDA. The warning from Wyeth is only for tablets and suppositories because these are the only two dosage forms of promethazine manufactured by Wyeth Pharmaceuticals. The IV form is manufactured by Baxter. At this time, Baxter has a black box warning regarding the use of promethazine injection in pediatric patients less than two years of age. However, it is not currently listed in the Contraindications section of the package insert.
The literature reveals cases of severe respiratory depression associated with promethazine use in children. However the available information is in abstract form and specific patient ages are not given. In the abstracts, promethazine was given in combination with other medications known to cause respiratory depression. For example, the majority of cases were with the combination of meperidine (Demerol®), promethazine, and chlorpromazine (Thorazine®). Reported doses were appropriate for each of the medications on a milligram per kilogram basis and were given via the parenteral route. The majority of the reports were with Emergency Department and inpatient use of the drug.
This issue was discussed at the recent Vanderbilt Children’s Hospital (VCH) Pharmacy and Therapeutics committee meeting, and the policy discussed still requires final approval from the Vanderbilt University Hospital P&T committee. The policy is as follows: if a physician writes for promethazine in a pediatric patient less than two years of age, a warning pops up stating that the medication is contraindicated in this patient population. The physician then must call the VCH pharmacy and speak with a pharmacist. If the physician still requests the medication after discussion with a pharmacist, the physician must contact the Head of the P&T committee.
For more information and specifics on individual cases, go to the FDA website at www.fda.gov and go through the following steps:
- On right side under FDA Activities, click link Freedom of Information
- On right side under More Information, click link Handbook for requesting information and records
- Half way down the page, follow steps under How to make a FOIA request.
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Thanks to Gina Ellis, Pharm D. for Question of the Week.
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