TO THE EDITOR:
The editorial comment by Avorn and Kesselheim (1) on recent systematic reviews of off-label use of rFVIIa raises concern about the “rapidly increasing use of a treatment that does not benefit patients and increases the risk for dangerous thrombotic events”—and “costs $10 000 per dose.” This concern, however, fails to consider the clinical context in which clinicians choose to administer rFVIIa, which is during refractory blood loss.
When presented with a patient who continues to bleed despite administration of all available therapies, clinicians have 2 choices: Keep administering the standard interventions that have failed to work in that ...
References
- 1.
Avorn J ,Kesselheim A . A hemorrhage of off-label use [Editorial]. Ann Intern Med. 2011;154:566-7. [PMID:21502655 ] LinkGoogle Scholar - 2.
Logan AC ,Yank V ,Stafford RS . Off-label use of recombinant factor VIIa in U.S. hospitals: analysis of hospital records. Ann Intern Med. 2011;154:516-22. [PMID:21502649 ] LinkGoogle Scholar - 3.
Karkouti K ,Beattie WS ,Arellano R ,Aye T ,Bussieres JS ,Callum JL ,et al . Comprehensive Canadian review of the off-label use of recombinant activated factor VII in cardiac surgery. Circulation. 2008;118:331-8. [PMID:18606914 ] CrossrefMedlineGoogle Scholar - 4.
Gill R ,Herbertson M ,Vuylsteke A ,Olsen PS ,von Heymann C ,Mythen M ,et al . Safety and efficacy of recombinant activated factor VII: a randomized placebo-controlled trial in the setting of bleeding after cardiac surgery. Circulation. 2009;120:21-7. [PMID:19546387 ] CrossrefMedlineGoogle Scholar - 5.
Levi M ,Levy JH ,Andersen HF ,Truloff D . Safety of recombinant activated factor VII in randomized clinical trials. N Engl J Med. 2010;363:1791-800. [PMID:21047223 ] CrossrefMedlineGoogle Scholar
Author, Article and Disclosure Information
From Toronto General Hospital, University of Toronto, Toronto, Ontario M5G 2C4, Canada, and Emory University School of Medicine, Atlanta, GA 30322.
Disclosures: The authors have consulted for and have received research funding from Novo Nordisk.
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