Evidence and desperation in off-label prescribing: recombinant factor VIIa.

Off label prescribing—that is, prescribing a medicine for an indication not listed in the product information, or for a patient outside the approved age range—is common, but controversial. On the one hand, it can promote clinical innovation and provide options for patients for whom no other alternatives are available. On the other hand, it can be harmful, because safety data are often lacking; it impedes the generation of good quality evidence, and it comes at a considerable cost to patients, governments, and other payers. 2 In this paper, we discuss the off-label use of recombinant factor VIIa (rFVIIa) for major haemorrhage, to provide insights into the forces driving off-label prescribing and to illustrate some of the inevitable limits to evidence based medicine. Clinical disagreement