First plasma-free thrombin product approved by FDA

Abstract

FDA and ZymoGenetics Inc. on January 17 announced the agency’s approval of Recothrom, the first recombinant, plasma-free thrombin product for use in helping stop bleeding from capillaries and small veins after surgery. The product’s official labeling describes one randomized, double-blind study that was conducted at multiple facilities. When applied with an absorbable gelatin sponge to a site with mild to moderate bleeding, the topical thrombin solution controlled the bleeding within 10 minutes in 95% of the surgical patients assigned to that treatment group. Incision-site complications were the most common adverse events reported during the clinical studies, FDA said. Nausea and surgery-related pain were also reported. The product’s labeling states that no one has established a causal relationship between the topical thrombin solution and specific adverse events. The labeling also states that the solution must not be injected directly into the bloodstream or used to treat massive or brisk arterial bleeding.