Severe Tissue Injury Prompts FDA Alert Regarding Promethazine HCl Injection

Concerns over the risk of severe chemical irritation and damage to tissues from the intravenous (IV) administration of promethazine hydrochloride injection has prompted labeling updates from the Food and Drug Administration (FDA). 

Promethazine hydrochloride injection is indicated to manage certain allergic reactions, motion sickness, post-operative nausea and vomiting, and as a sedative or adjunct to analgesics.

According to the FDA safety alert, health care professionals are recommended to administer promethazine hydrochloride injection via deep intramuscular (IM) administration to reduce the risk of severe tissue injury. If IM administration is not possible, promethazine hydrochloride injection:

• Can be administered intravenously only after dilution, as recommended, and infused through an IV catheter inserted in a large vein and preferably through a central venous catheter. Do not administer using IV catheters placed into veins in the hand or wrist.
• Should not be mixed with other drugs or diluted with solutions other than 0.9% sodium chloride injection.
• Is contraindicated for IV injection at concentrations greater than 1mg/mL.

The preparation and infusion instructions for IV administration of promethazine hydrochloride injection can be found here. Moreover, the FDA is requiring manufacturers to update their prescribing information for promethazine hydrochloride injection to include new safety information and update the carton labeling and container labels.

Adverse event reports related to the use of this product should be reported to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.