Tuesday, September 22, 2009
Pharmalittle brings news of an interesting post-script to the Supreme Court's decision in Wyeth v. Levine (pdf) last March. In Wyeth, Diana Levine won a $7.4 million damages award against Wyeth after losing her arm to gangrene from an improper injection of the drug promethazine. Levine contended that Wyeth failed to adequately warn of the risks of using an IV-push method of administering the drug. The Supreme Court rejected Wyeth's implied preemption arguments and upheld the award.
Now, in a ruling issued last week, the FDA is requiring a "black box" warning that "due to the risks of intravenous injection, the preferred route of administration is deep muscular injection and that subcutaneious injection is contraindicated." The FDA news release explains:
Promethazine should neither be administered into an artery nor administered under the skin because of the risk of severe tissue injury, including gangrene, the boxed warning says. 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. As a result of these risks, the preferred route of administration is injecting the drug deep into the muscle.