S G Baxter Healthcare Corporation and the American Red Cross have issued joint warnings of a possible link between intravenous immunoglobulin and serious thrombotic events that could lead to chest pain, congestive heart failure, and myocardial infarctions in certain patients.
The two organisations have posted their warning on the website of the US Food and Drug Administration (www.fda.gov/ medwatch/SAFETY/2002/ safety02.htm#igiv). Baxter has also sent a warning letter to physicians.
Intravenous immunoglobulin consists of antibodies derived from pooled human plasma, which are stabilised with sugars or proteins. The product helps to fight infection in those with weakened immune systems and is commonly used in patients with HIV, hepatitis C, a bone marrow transplant, certain leukaemias, and neurological diseases such as Guillain-Barré syndrome.
Although the exact cause of the clot related problems is unknown, rapid infusion of intravenous immunoglobulin is considered a “possible risk factor,” according to Baxter (which makes one product, Gammagard S/D) and the Red Cross (which distributes a second, Polygam S/D).