Promethazine Hydrochloride Injection - On 16-Sep-2009, US FDA notified healthcare professionals that a Boxed Warning is being added for Promethazine HCl products alerting the risks of severe tissue injury, including gangrene, requiring amputation following IV administration of promethazine.

The Boxed Warning will remind practitioners that due to the risks of IV injection, the preferred route of administration is deep IM injection and that SC injection is contraindicated. Perivascular extravasation, unintentional intra-arterial injection and intraneuronal or perineuronal infiltration of the drug may result in irritation and tissue damage. Healthcare professionals should be alert for signs and symptoms of potential tissue injury including burning or pain at the site of injection, phlebitis, swelling, and blistering.
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