Off-Label Use of Recombinant Factor VIIa
Authors: Anne Phillips
Journal: Annals of Internal Medicine (2011)

Letters6 September 2011Off-Label Use of Recombinant Factor VIIaAnne Phillips, MD, Vice President, Clinical, Medical and Regulatory AffairsAnne Phillips, MD, Vice President, Clinical, Medical and Regulatory AffairsFrom Novo Nordisk, Princeton, NJ 08540.Search for more papers by this authorAuthor, Article, and Disclosure Informationhttps://doi.org/10.7326/0003-4819-155-5-201109060-00020 SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail TO THE EDITOR:In the 19 April 2011 issue, Logan and colleagues (1) and Yank and colleagues (2) presented summaries of their assessment of use of recombinant factor VIIa (rFVIIa), sponsored by the Agency for Healthcare Research and Quality (AHRQ) (3). Novo Nordisk is concerned that these articles do not put rFVIIa use into proper context. Most rFVIIa is used in patients with hemophilia with inhibitors in the outpatient setting.In 1972, Ulla Hedner discovered that coagulation factor VII was able to bypass factor VIII/IX–mediated clotting in patients with hemophilia complicated by alloantibodies. Because of the limited availability of plasma ...References1. 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 Scholar2. Yank V, Tuohy CV, Logan AC, Bravata DM, Staudenmayer K, Eisenhut R, et al. Systematic review: benefits and harms of in-hospital use of recombinant factor VIIa for off-label indications. Ann Intern Med. 2011;154:529-40. [PMID: 21502651] LinkGoogle Scholar3. Yank V, Tuohy CV, Logan AC, Bravata DM, Staudenmayer K, Eisenhut R, et al. Comparative Effectiveness of Recombinant Factor VIIa for Off-Label Indications vs. Usual Care. Rockville, MD: Agency for Healthcare Research and Quality; 2010. Accessed at www.effectivehealthcare.ahrq.gov/reports/final.cfm on 18 April 2011. Google Scholar4. Kenet G, Walden R, Eldad A, Martinowitz U. Treatment of traumatic bleeding with recombinant factor VIIa [Letter]. Lancet. 1999;354:1879. [PMID: 10584732] CrossrefMedlineGoogle Scholar5. Lin Y, Stanworth S, Birchall J, Doree C, Hyde C. Recombinant factor VIIa for the prevention and treatment of bleeding in patients without haemophilia. Cochrane Database Syst Rev. 2011;:CD005011. [PMID: 21328270] MedlineGoogle Scholar6. Hsia CC, Chin-Yee IH, McAlister VC. Use of recombinant activated factor VII in patients without hemophilia: a meta-analysis of randomized control trials. Ann Surg. 2008;248:61-8. [PMID: 18580208] CrossrefMedlineGoogle Scholar7. 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 InformationAffiliations: From Novo Nordisk, Princeton, NJ 08540.Disclosures: Dr. Phillips is an employee of Novo Nordisk. PreviousarticleNextarticle Advertisement FiguresReferencesRelatedDetailsSee AlsoOff-Label Use of Recombinant Factor VIIa in U.S. Hospitals: Analysis of Hospital Records Aaron C. Logan , Veronica Yank , and Randall S. Stafford Systematic Review: Benefits and Harms of In-Hospital Use of Recombinant Factor VIIa for Off-Label Indications Veronica Yank , C. Vaughan Tuohy , Aaron C. Logan , Dena M. Bravata , Kristan Staudenmayer , Robin Eisenhut , Vandana Sundaram , Donal McMahon , Ingram Olkin , Kathryn M. McDonald , Douglas K. Owens , and Randall S. Stafford Off-Label Use of Recombinant Factor VIIa Awori J. Hayanga Off-Label Use of Recombinant Factor VIIa Veronica Yank , Aaron C. Logan , and Randall S. Stafford Metrics 6 September 2011Volume 155, Issue 5Page: 337KeywordsCoagulopathyDatabasesHemophiliaHemorrhageOutpatient clinicsResearch quality assessmentRisk managementSafetySurgerySurgical repair ePublished: 6 September 2011 Issue Published: 6 September 2011 CopyrightCopyright © 2011 by American College of Physicians. All Rights Reserved.PDF DownloadLoading ...