Promethazine regulatory update

FDA said it will require manufacturers of promethazine to include a boxed warning about the risk of serious tissue injury when this drug is administered incorrectly. The label will state that promethazine should neither be administered into an artery nor under the skin because of the risk of severe tissue injury, including gangrene. Additionally, the label will warn of a risk that the drug can leach out from the vein during IV administration and cause serious damage to the surrounding tissue. FDA advises that the preferred route of administration is injection deep into the muscle. The existing label contains a similar warning that is not highlighted as a boxed warning. ...