Alerts
Promethazine Hydrochloride Injection – Black Box Warning for Severe Tissue Injury
September 17, 2009
The FDA is requiring manufacturers of promethazine hydrochloride injection to add a black box warning to the labeling explaining the risks of severe tissue injuries associated with the intravenous administration of promethazine. Gangrene is among the types of tissue injury that have been reported after intravenous administration of promethazine; some cases have required amputation. The warning will re-emphasize that administering promethazine subcutaneously is contraindicated. Deep intramuscular injection is the preferred administration route.
Do not administer promethazine under the skin or into an artery. Extravasation, subcutaneous injection, intraneuronal or perineuronal infiltration, and inadvertent intra-arterial administration may cause severe tissue injury.
Promethazine was once sold under the brand name Phenergan but is now available as a generic. Healthcare providers need to monitor patients for phlebitis, blistering, swelling, and for burning or pain at the injection site.
Additional information is available at the following links:
- MedWatch Alert:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm182500.htm - FDA News Release:
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm182498.htm - FDA Information for Healthcare Professionals:
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ DrugSafetyInformationforHeathcareProfessionals/ucm182169.htm
Updated
September 17, 2009; University of Utah, Drug Information Service. Copyright 2009, Drug Information Service, University of Utah, Salt Lake City, UT.
