Promethazine FDA Boxed Warning

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Intravenous news: FDA is requiring a Boxed Warning for promethazine hydrochloride injection, USP products to better communicate the risks of severe tissue injury associated with administration of this drug. Perivascular extravasation, unintentional intra-arterial injection and intraneuronal or perineuronal infiltration of the drug may result in irritation and tissue damage, including gangrene. 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 analysis of post-marketing reports of severe tissue injury, including gangrene, requiring amputation following intravenous administration of promethazine as well as FDA 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.

In addition to the Boxed Warning, FDA is requiring a revision to the Dosage and Administration section to increase the visibility and accessibility of specific recommendations for the maximum concentration (25 mg per mL) and rate of administration (25 mg per minute) when intravenous administration of promethazine is required.

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