This started as a comment in response to a post by WhiteCoat about the pending supreme court lawsuit of Wyeth v. Levine (although shouldn't it be Levine v. Wyeth?) but grew to the point where it asked to be it's own post. To understand what I am referring to, however, please go read WhiteCoat's original post.Back? Good. Here is my comment:
That is so ridiculously ridiculous of ridiculousity. First of all, and in the woman's defense, Phenergan already comes with strong warnings about using it IV, and the PA in this case (based on my totally incomplete knowledge of the facts) was in the wrong with how he administered the medication. I can't imagine giving the medication by an IV route that doesn't verify line patency or placement. In fact, in my ER, when we pull Phenergan out of the Pyxis, we have to sign that we will dilute it and give over at least two minutes (actually slower than manufacturer's warning). I don't have access to the manufacturer's label, but Gahart's IV Drug Manual (perhaps the Bible of IV medications) says:
A vesicant; determine absolute patency of vein; extravisation will cause necrosis... ISMP suggests administering through large bore veins but prefers use of a central venous catheter. Administration through hand or wrist veins is strongly discouraged.It further says:
The ISMP recommends administration of a single dose over 10 to 15 minutes administered at a port furthest from the patient's vein; observe continuously if given into a peripheral vein.And even further says:
The ISMP recommends 6.25 to 12.5 mg as a starting IV dose and suggests considering the use of alternate drugs.All of that said, Phenergan, when given properly via the IV route is a safe and effective drug - if somewhat more dangerous than others - and the idea of suing the drug manufacturer for ineffective labeling on this issue is moronic. I love Zofran and really could care less if Phenergan were taken off the IV list (except it is really nice when the Doc orders it with Dilaudid because they are syringe compatible, where Zofran is not). Despite this concern of convenience, I'm worried, because if this case succeeds in front of the Supreme Court, then there will be precedent for disallowing IV administration of so many other drugs that can cause arteriospasm, including such mainstays as IV Ativan.
Yes, you read that right. No more Ativan.
Now are you concerned? Me too.
Solution? Send all our crayzees over to the Supreme Court so that they know what they are facing. Tell them "sorry, we can't do anything because you took away our vitamin A."
That'll learn them.
4 comments:
So... what *is* your opinion on the issue at hand, which is preemption? It would seem that you side with Wyeth when you write things like: "First of all, and in the woman's defense, Phenergan already comes with strong warnings about using it IV..."
I don't have sufficient legal knowledge, not medical -- but I can usually tease out someone's stance. Not here, though!
I am no fan of preeminence, because there is a lot of aftermarket surveillance that happens after the FDA approves a drug (which basically only requires a few studies showing it doesn't have major side effects and a few RCT's showing it is more effective than placebo). To hold the FDA entirely liable for a drug's (or stent's) safety and hold the company blameless seems wrong to me.
On this case, though, it seems to be a poor test case for preeminence, as the warnings are stated explicitly and the whole reason this patient suffered a terrible consequence is because the PA effed up.
I'm not a lawyer, don't pretend to be one, but the idea of losing IV Ativan scares the dickens out of me. 'Nuff said.
Will be watching this closely though.
It's an appellate case, so the defendant ends up in the plaintiff position. It started off as Levine v. Wyeth and on appeal is Wyeth v. Levine.
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