Pro/con debate: does recombinant factor VIIa have a role to play in the treatment of patients with acute nontraumatic hemorrhage?

Perhaps it is not surprising that in the critical care environment, where lives are frequently on the line, off-label use of certain drugs is relatively common. In general, there are two camps of opinion on this type of utilization. One camp would suggest that potentially life saving products cannot ethically be withheld from patients who may benefit. The other camp would counter that it is inappropriate to administer products if the risk/benefit ratio has not been clearly defined in clinical trials. Off-label use of factor VII is debated in this issue of Critical Care for a patient with uncontrolled nontraumatic hemorrhage. Perhaps this product promotes additional discussion given that its ability to control bleeding can be dramatic, yet its costs and potential for complications high.