How can any clot-busting drug for cardiology be approved without data on post-surgical bleeding complications after defibrillator or pacemaker implantation?
Just asking.
(I wonder what the FDA's (absent) Safety and Risk Management committee might have said.)
-Wes
Reference: "Prasugrel versus Clopidogrel in Patients with Acute Coronary Syndromes," New Engl J Med, November 15, 2007, 357(20):2001-2015.
FYI, the Sanjay Kaul absence was first reported on a new blog, www.cardiobrief.org. You can also find there an interesting post concerning the FDA briefing document for prasugrel. Redacted information was able to be recovered from the PDF document originally posted on the FDA site.
ReplyDeleteAnony 10:34 -
ReplyDeleteThanks. Although the absence of Sanjay Kaul was notable, I look at this issue even more practically. We have seen the development and promotion of countless antithromotic and antiplatelet agents in our field (for good reason), but little data regarding long-term effects of these drugs to other specialties or subspecialties. One only has to look at enoxaparin (Lovenox) - a drug heavily promoted for DVT prophylaxis (what EMR doesn't remind us of the need for treatment of our patients for this these days?) and its effects on post operative bleeding to understand my concerns. Ask any electrophysiologist about Lovenox after a pacemaker, and you'll hear horror stories of hematomas, hemopericardium and the like. I've had to resort to an order on all my post-op orders, just to avoid the use of this drug. Worse - the drug has no rapidly-acting antidote to its effects (unlike protamine for heparin's effects).
Enter prasugrel. Now we get a new "super-antiplatelet agent" that, according to Eugene Braunwald, the "use of prasugrel would prevent 23 000 MIs and 4000 deaths annually at a cost of an additional 2300 major bleeding events." And that's just acutely. It doesn't include the later issues that might be seen after even minor procedures like lumbar punctures (yes, there are issues with this and the weaker clopidogrel) and things like pacemaker or defibrillator implant. Is there any guidance on how to manage this drug around periods of minor surgery? No.
Why this seems like such a moot point for an antiplatelet agent when we've seen the problems with rarer things like QTc prolongation in drugs (and now EVERY drug must be tested for this) is beyond me.
fyi:
ReplyDeletehttp://cardiobrief.org/2009/02/09/editorial-prasugrel-and-fda-incompetence/