FDA Issues Warning about Promethazine Hydrochloride Injection

The FDA has issued a notification to healthcare professionals that a Boxed Warning is being added to the prescribing information for Promethazine Hydrochloride products, describing the risks of severe tissue injury, including gangrene, requiring amputation following intravenous administration of promethazine.

The Boxed Warning will remind practitioners that due to the risks of intravenous injection, the preferred route of administration is deep intramuscular injection and that subcutaneous injection is contraindicated.

This action is based on FDA's analysis of post-marketing reports of severe tissue injury, including gangrene, requiring amputation following intravenous administration of promethazine as well as FDA's review of the current prescribing information for these products. FDA has determined that the presentation, organization, and content of the prescribing information should be revised to more effectively communicate the risk of severe tissue injury following intravenous administration.

Promethazine hydrochloride injection, USP is approved for a variety of uses including allergic reactions, sedation, motion sickness, nausea, and vomiting associated with anesthesia and surgery, and as an adjunct to analgesics for control of postoperative pain.

SEPT-16-09: FDA issues warning about Promethazine Hydrochloride Injection [FDA: WARNING ISSUED ABOUT PROMETHAZINE HYDROCHLORIDE]

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Published on Sep-16-09