U.S. Food and Drug Administration
FDA Requires Boxed Warning for Promethazine Hydrochloride Injection
Published in Health Business Week, October 2nd, 2009
The U.S. Food and Drug Administration is telling 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.
Promethazine should neither be administered into an artery nor administered under the skin because of the risk of severe tissue injury, including gangrene, the boxed warning says. There is also a...
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Source: Health Business Week (2009-10-02)
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