A drug that's been in use for more than half a century will now have a black box warning.
Injectable promethazine--a prescription generic used as a sedative and to treat nausea and vomiting--will now come with information declaring risk of serious tissue injury when administered improperly, according to the FDA. The drug received market approval as Phenergan by Wyeth in 1956, when Dwight Eisenhower was President and IBM invested the hard disk drive.
The regulator's actions follow a Supreme Court decision yesterday in which a Vermont musician, Diana Levine, sued Wyeth after her experience with the medication. Levine had received the drug by intravenous push in 2000. Complications led eventually to the amputation of her lower right arm.
In addition to the $6.7-million jury award, the ruling is also significant for what it may signal to drug makers concerning FDA approval as a defense against individuals who attempt to sue.
- here's the FDA notice
- read this article