Self‑Controlled Assessment of Thromboembolic Event (TEE) Risk Following Intravenous Immune Globulin (IGIV) in the U.S. (2006–2012)

Since 2013, the U.S. Food and Drug administration (FDA) has required that intravenous immune globulin (IGIV) products carry a boxed warning concerning the risk of thromboembolic events (TEEs). Prior studies have varying estimates of the frequency of thromboembolic events (TEEs) in patients receiving intravenous immunoglobulin (IGIV).

We conducted a large population-based safety assessment of TEE incidence attributed to IGIV administration. 442 potential cases were identified from the Sentinel Distributed Database and confirmed through medical record review among 19,069 new IGIV users and 93,555 treatment episodes.