New Black Box Warning for Promethazine

The Food and Drug Administration has warned health care professionals that intravenous administration of promethazine can lead to serious tissue damage including gangrene that requires amputation.  Deep intramuscular injections are the preferred method of giving the drug, and injections just under the skin or injections into an artery are contraindicated.

The FDA is requiring that manufacturers of promethazine place a boxed warning on its label and revise the label content and organization to stress the importance of avoiding IV administration.  If IV administration is required, the drug should not exceed a maximum concentration or speed of IV drip.

Previously promethazine was marketed under the brand name Phenergan® but is now marketed as a generic by several companies. It is used to treat allergies, severe allergic reaction, and to manage nausea and vomiting after surgery.  It is also used as a sedative and to control post-surgical pain.

The FDA tells patients

  • Discuss any concerns you may have about the risks and benefits of promethazine with a health care professional.
  • Understand that side effects may occur immediately while receiving a promethazine injection or may develop hours to days after an injection.
  • Pay close attention for any signs or symptoms of adverse events including burning or pain at the injection site, redness, swelling, and blistering, and report these symptoms immediately.

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