The Food and Drug Administration said Tuesday makers of the antihistamine and anti-nausea drug promethazine have to warn consumers over the potential risk of tissue injuries including gangrene if the injectable drug is administered incorrectly.
The FDA is requiring companies to include a warning on the drug's label to state that it should not be administered into an artery or under the skin because of the risk. There is also a risk that the drug can leach out from the vein during intravenous administration and cause serious damage to the surrounding tissue, the agency said.
The drug should be injected deep into a muscle.
Also, a requested revision to the label proposes that if health care professionals choose to administer promethazine intravenously, they should limit the drug's concentration and rate of administration.
Companies making the drug are required to submit safety label changes to the FDA within 30 days or provide a reason why they feel changes are not necessary.
Promethazine was previously sold under the brand name Phenergan by Wyeth, but the company discontinued the formulation. Several generic drug developers now make formulations of the injectable drug. The drug first hit the market in 1956 and prior warnings over potential tissue injuries have been stated, but have not been required to be included in a box warning.