Sedation Drug Gets Black Box Amputation Warning

Promethazine, a sedative used to treat such conditions as nausea and vomiting, has received a black box warning (the strongest available) from the FDA. The warning comes after the sedation drug has been linked to a higher risk of amputation. The drug’s brand name Phenergan was involved in a highly publicized Supreme Court case earlier this year. Wyeth Pharmaceuticals, the maker of promethazine, will have one month to created the wording for the black box warning.
According to an Associated Press report, “The FDA said Wednesday that makers of generic promethazine will have to put a “black box” warning at the top of the detailed package insert explaining that when the drug is administered incorrectly, it can damage skin severely, including causing gangrene.
The FDA said promethazine should be injected deep into muscle, never into an artery or under the skin and, when given intravenously, it should be done slowly and at a low concentration. That’s because the drug can leach out of a vein and seriously damage surrounding tissue.”