On Patient Safety: Concerns About Topical Tranexamic Acid in Spine Surgery

Abstract

The goal of "On Patient Safety" column is to highlight key safety messages about clinically relevant topics. In this month's guest column, Dr. Tian-qing Li and colleagues discuss the safety issues related to the off-label use of topical tranexamic acid (TXA) in spine surgery. TXA is an antifibrinolytic agent that is widely used around the world to reduce blood loss in joint replacement; its use has recently increased in spine surgery for the same indication. Their column highlights the safety concerns associated with the off-label use of any potent therapeutic agent; however, these concerns are heightened in this case by the serious risk of inadvertent intrathecal administration of TXA resulting from an intraoperative dural tear or other complication, which can lead to a truly catastrophic result.Their essay spotlights several components needed for the safe use of offlabel drugs and medical devices. The authors discuss the increased need for appropriate informed consent for our patients whenever we use TXA off-label, and they also note serious knowledge gaps among surgeons who routinely use this product off-label. Additionally, the authors highlight the need for appropriate studies to confirm the safety profile of off-label uses of TXA.Many surgeons use drugs and devices off-label in ways that are safe. Addressing the concerns pointed out by Dr. Li and colleagues in off-label usage of TXA will increase patient safety for this drug, and doing so points the way for safer administration of other off-label therapeutics.