The FDA has notified 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. 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. 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.
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 (25mg/mL) and rate of administration (25mg/min) when intravenous administration of promethazine is required.
Promethazine hydrochloride injection 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.
For more information visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm182500.htm.