Phenergan (also known as promethazine), a drug intended for use as an intravenous anti-nausea drug has been required to have a strict safety warning placed on its label by Food and Drug Administration. What’s caused the FDA to act so strongly? Apparently Phenergan when injected by accident into an artery can cause serious tissue damage and even gangrene, issues that could become serious enough to require amputation.
The decision to demand a warning comes after a Supreme Court case was made forcing Wyeth, the drug’s maker to pay 6.8 million to a Vermont musician who lost her arm and hand to the drug after it was accidently injected into an artery in 2000. In an appeal Wyeth pled that the FDA had labeled a less strict warning adequate enough for the drug. At the time drug companies were hoping that cases like this one would kill lawsuits made by people who felt that drug warnings weren’t clear enough about the potentially harmful and debilitating effects of certain drugs and therefore caused their injuries. Was drug maker Wyeth or the FDA more responsible for any harmful side effects that occurred due to the less than clear warning placed on the drug?
It seems clear based on this change in the warning that the FDA is starting to be more concerned with protecting patients and upholding safety than they once appeared to be.