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Black box warning for anti-nausea drug; risk of gangrene
September 18th, 2009 by Jennifer Walker-Journey
An injectable form of a popular anti-nausea medication has received a black box warning by the Food and Drug Administration (FDA) because of a risk of severe tissue injury, including gangrene, requiring amputation. The drug, Promethazine Hydrochloride Injection, formerly known by the brand name Phenergan, is available by pill, suppository and injection. The recall covers only the injectable form.
Promethazine was previously sold under the brand name Phenergan, but that formulation was discontinued by Wyeth Pharmaceuticals Inc. A number of companies currently market generic formulations of promethazine hydrochloride injection.
Promethazine hydrochloride as an injectable is indicated for various conditions including for sedation and relief of apprehension and to produce light sleep from which the patient can easily be aroused; active treatment of motion sickness; prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery; and preoperative, postoperative and obstetric (during labor) sedation. The medication has a previous black box warning against using the injectable in pediatric patients less than two years of age because of the risk of fatal respiratory depression.
The new 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. 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 of the signs and symptoms of potential tissue injury including burning or pain at the site of injection, phlebitis, swelling and blistering.
