September 16, 2009

FDA requires promethazine warning

The U.S. Food and Drug Administration announced Wednesday it will require a boxed warning for the injectable form of the drug promethazine.

FDA officials said the warning will highlight the risk of serious tissue injury when the drug is administered incorrectly. Promethazine is used as a sedative and to treat nausea and vomiting.

Promethazine should neither be administered into an artery nor administered under the skin because of the risk of severe tissue injury, including gangrene, the FDA boxed warning says. The FDA said the preferred route of administration is injecting the drug deep into a muscle.

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 FDA said.

Companies that manufacture 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.

The FDA said promethazine was previously sold under the brand name Phenergan, but that formulation was discontinued by Wyeth Pharmaceuticals Inc. A number of companies currently market generic formulations of promethazine hydrochloride injection.