FDA Requires Boxed Warning For Promethazine Hydrochloride Injection

The US Food and Drug Administration (FDA) has asked the manufacturers of the drug promethazine to include a boxed warning regarding the injectable form of the drug. The warning, under FDA’s authority to require safety labeling changes, will highlight the risk of serious tissue injury when this drug is administered incorrectly.

The agency is also alerting health care professionals to the new boxed warning for this product, which is used as a sedative and to treat nausea and vomiting. The boxed warning says, Promethazine should neither be administered into an artery nor administered under the skin because of the risk of severe tissue injury, including gangrene, according to FDA.

A requested revision in the Dosage and Administration section of the label states that if health care professionals choose to administer promethazine intravenously, they should limit the drug’s concentration and rate of administration and ensure a properly functioning intravenous line.

The companies that make promethazine are required to submit the requested safety label changes to the FDA within 30 days or provide a reason why they do not believe such changes are necessary.

Promethazine was previously sold under the brand name Phenergan, but that formulation was discontinued by Wyeth Pharmaceuticals.