A black-box warning is now required for the injectable form of promethazine drug , a sedative and an antinausea/antiemetic agent. The warning highlights the risk of serious tissue injury when the drug is administered incorrectly.
The prescribing information will warn that cheap promethazine should not be injected into an artery or under the skin because of the risk of severe tissue injury, including gangrene. There is also a risk that the drug might leach out from the vein during IV administration and can cause serious damage to the surrounding tissue. The preferred route is deep into the muscle.
A requested revision in the Dosage and Administration section of the label states that if health care professionals use the IV route, they should limit the drug’s concentration and rate of administration and should ensure a properly functioning IV line.
Generic Promethazine first went on the market in 1956 and had been sold as generic Phenergan, but Wyeth discontinued that formulation. Several companies currently market generic formulations. The FDA previously issued alerts about the risks of incorrect administration in 2006 and 2008.
Source: FDA, September 16, 2009