FDA Orders Black Box Warning for Phenergan

The FDA has just ordered that special warnings be added to the instructions for the use of the anti-nausea medication, Phenergan (promethazine). This so-called “Black Box” warning is the FDA’s strongest possible warning about the use of this drug via intravenous (IV) administration. Specifically, the new warning describes the potential serious complications of inadvertent intra-arterial injection, infiltration or extravasation of Phenergan. These complications can include severe tissue or nerve damage, gangrene and amputation. The new warnings also make clear that deep intramuscular injection is the preferred route of administration.

Our firm has handled many cases involving injury to patients from IV administration of Phenergan. Many of these patients went on to develop Reflex Sympathetic Dystrophy (RSD) or Chronic Regional Pain Syndrome (CRPS). If you believe you have been injured by intravenous injection of Phenergan and would like to speak with an attorney experienced in this area, we would be happy to discuss your potential case with you.

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