FDA announces new box labeling requirements for promethazine hydrocloride due to serious risks associated with the injection of the drug

There is a risk of serious tissue injury and damage anytime the injection of prommethazine hydrochoride (also known under the brand name of Phenergan by Wyeth Pharmaceuticals, Inc.)is incorrectly administered. The drug, a sedative, is used primarily for treating vomiting and nausea. The drug should never be administered into an artery nor administered or injected under the skin since there is a risk of severe tissue damage including gangrene. Wyeth discontinued the manufacture of Phenergen but there are a number of manufacturers who continue to market and distribute a generic form of the drug.

The U.S. Food and Drug Administration is now instructing manufacturers of the drug promethazine to include a boxed warning regarding the injectable form of the drug. The warning, under FDA’s authority, requires safety labeling changes that 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. There is also a risk that the drug could leach from a vein during intravenous administration that could cause serious damage to the adjacent or surrounding tissues; hence, if the drug is administered intravenously, the concentration and rate of administration should be limited to ensure a properly functioning intravenous line.

Due to the aforementioned risks, the FDA has announced that manufacturers are required to submit proposed safety label warnings to accompany the sale of each drug within 30 days or show cause as to why the changes should not be made.

The FDA previously informed consumers and health care professionals about the risks of incorrect administration of promethazine in the December 2006 and February 2008 editions of FDA Patient Safety News. Current prescribing information for the drug contains information about the risk of tissue injury, possibly including gangrene, if the drug is inadvertently administered in the artery, but that information was not highlighted in a boxed warning.

Promethazine first went on the market in 1956. FDA has reviewed the published literature and post-marketing adverse event reports submitted to the agency’s Adverse Event Reporting System from 1969 to 2009 and identified cases of gangrene requiring amputation associated with administration of the drug.
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