Tuesday, July 12, 2011

Off-label use of recombinant factor VIIa---evidence based review of efficacy and safety

Despite the fact that recombinant factor VIIa is physiologically appealing for a variety of bleeding scenarios its approved indications are extremely limited. It is estimated that over 90% of its use is off -label. Here is a review of the evidence regarding VIIa for various off-label uses. The evidence of benefit in terms of hard clinical endpoints is scant, and in the off-label population the VTE risk is higher. Recommendations vary from guideline to guideline. The authors conclude:

In the absence of clearly supportive data, and with much data suggesting an increased risk of TAEs, we recommend that practicing hematologists exercise restraint in the use of rFVIIa in off-label settings. Until better quality and more statistically significant data regarding the use of rFVIIa in different off-label scenarios become available, we believe it is useful for professional organizations to develop conservative evidence-based guidelines for use of rFVIIa in off-label settings that should be updated frequently to reflect findings from new trials. We hope that patient safety will be appropriately guarded by this mechanism, while encouraging physicians to adapt their clinical practice to fresh evidence.

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