Tag Archives: promethazine

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.