FDA Calls for Boxed Warning on Promethazine Hydrochloride Injection

Injectable promethazine hydrochloride (former brand name, Phenergan) should carry a boxed warning to emphasize the risk for severe tissue injury when the drug is given incorrectly, the FDA announced on Wednesday. (Promethazine is used as a sedative and to treat nausea and vomiting.)

The agency says intramuscular injection is preferable.

Intra-arterial or subcutaneous promethazine injection can result in gangrene and other serious tissue injury, while during intravenous administration, the drug can "leach out" from the vein and harm nearby tissue. Clinicians who choose intravenous delivery should limit the drug's concentration and the speed of administration, the FDA says.