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U.S. Department of Health and Human Services

Safety

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Immune Globulin Intravenous (Human) [IGIV]

Audience: Healthcare professionals

(UPDATE Posted August 27, 2002): Certain information in the previously posted American Red Cross and Baxter letters (dated March 26, 2002 and posted April 22, 2002) may suggest that these products are more safe than another product on the market. At this time, there is no conclusive evidence to support this suggestion. Please refer to updated information below that is provided by the FDA as of August 27, 2002.
 

(Posted April 22, 2002) There have been post marketing reports describing serious thrombotic events (vascular occlusion) possibly associated with the administration of Immune Globulin Intravenous (Human) (IGIV). Precautionary statements, advising physicians to exercise caution in administering IGIV to patients with cardiovascular disease or previous thrombotic events, have been added to the labeling of both Baxter's Gammagard S/D and American Red Cross' Polygam S/D. The letters remind healthcare professionals of measures that may be important in reducing the risk of a thrombotic event.

[August 27, 2002 - UPDATE - FDA]
[March 26, 2002 - Letter - Baxter]
[March 26, 2002 - Letter - American Red Cross]