FDA Interim Statement Regarding Immune Globulin Intravenous (IGIV)
August 22, 2002
Several manufacturers of Intravenous Immune Globulin (Human) (IGIV) have sent letters to healthcare providers reporting the occurrence of thrombotic events following IGIV infusion. We are currently investigating these reports. It has not been established whether or not these thrombotic events were caused by IGIV administration. Additionally, we do not have sufficient evidence to implicate a specific characteristic of IGIV products, such as excipients, concentration, or trace procoagulant activity to account for an increased thrombotic tendency in recipients.
Because the information contained in the letters is inconclusive and may suggest that the products are safer than another product on the market, we are issuing this statement to supercede the information presented in the letters sent by manufacturers. We will provide additional information when our review and analysis are complete.
In the interim, prescribers and other healthcare professionals should be aware that rapid infusion rates and high doses of IGIV might be potential risk factors for this complication in patients who are already at risk for thrombotic events.
For questions regarding this information call CBER, Office of Communication, Training and Manufacturers Assistance at 800-835-4709.