Off-Label Use of Recombinant Factor VIIa High

No mortality reduction found for off-label indications; may raise thromboembolism risk

WEDNESDAY, April 20 (HealthDay News) -- Off-label use of recombinant factor VIIa (rFVIIa) in the hospital setting greatly exceeds use for approved indications; off-label use does not appear to reduce mortality and may increase the risk for thromboembolism, according to research published in the April 19 issue of the Annals of Internal Medicine.

In a retrospective database analysis, Aaron C. Logan, M.D., Ph.D., of the Stanford University School of Medicine in California, and colleagues evaluated 12,644 hospitalizations for patients who received rFVIIa during a hospital stay. The investigators found that off-label use of rFVIIa in the hospital setting substantially exceeded use for approved indications.

In a systematic review, Veronica Yank, M.D., of Stanford University in California, and colleagues evaluated the efficacy and safety of rFVIIa for five off-label, in-hospital indications: intracranial hemorrhage (ICH), cardiac surgery, trauma, liver transplantation, and prostatectomy. The investigators included 16 randomized controlled trials, 26 comparative observational studies, and 22 non-comparative observational studies. The data revealed no mortality reduction with off-label rFVIIa use for the five indications and showed an increase in thromboembolism for some indications.

"These studies provide rigorous, unbiased assessments of both utilization patterns and clinical evidence that can serve as a model for the many other issues of rational therapy decisions that physicians, patients, and policymakers face," write the authors of an accompanying editorial.

Two authors of the second study disclosed financial relationships with Sanofi-Aventis, Generation Health, and/or Mylan Pharmaceuticals.

Abstract - Logan
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Abstract - Yank
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