Caution With the Use of Recombinant Activated Factor VII in Treating Postoperative Hemorrhage in Cardiac Surgery

Ethics & Evidence in Medical Debates: The Case of Recombinant Activated Factor VII

“…Some stakeholders emphasized their personal experiences with rFVIIa and the number of positive case reports published . Others emphasized the physiological rationale for using rFVIIa to treat bleeding in any context, while others were skeptical of the validity of clinical anecdotes, case reports, and mechanistic accounts and emphasized the necessity for practice to be based upon high‐level analyses, particularly randomized controlled trials . For instance, Veronica Yank and Randall S. Stafford stated that there was no convincing epidemiological evidence of rFVIIa's efficacy, leading them to “strongly caution against such wide adoption of off‐label therapeutics without convincing evidence of efficacy and adequate studies of harm.”…”