Recombinant Factor VIIa for Bleeding?

Recombinant Factor VIIa (rFVIIa) is a potent blood coagulating agent that is officially approved for use only in hemophiliacs. However, a recent study of over twelve thousand patients who received rFVIIa in U.S. hospitals revealed that by 2008, 97% of the in-hospital use of rFVIIa was “off-label” (meaning for uses other than in hemophiliacs.) The most common uses were to reduce bleeding in patients with severe trauma or intracranial hemorrhage, or during cardiac surgery, liver transplantation, or prostatectomy.

U.S. law allows physicians to use drugs for off-label purposes because of a deeply-held belief that only the physician and the patient can determine what is best for each patient. This would make perfect sense if the drug really worked for these off-label purposes. But a review of the available literature (by some of the same authors) reveals that rFVIIa does not reduce mortality when used for any of five off-label uses described above.

Physicians who used rFVIIa off-label in the past were not necessarily wrong to use the drug, of course, because up until now they didn’t have the full information. But now that they do know (or at least should), one would hope that they would examine the need for rFVIIa more closely, especially since the drug costs about $10,000 per dose.