Potentially Fatal Hemolysis Linked to IV Immune Globulin

FDA and manufacturer update label of intravenous human immune globulin WinRho SDF

MONDAY, Jan. 9 (HealthDay News) -- The U.S. Food and Drug Administration, Baxter Healthcare Corporation and Cangene Corporation have notified health professionals that there have been reports of rare but severe, and sometimes fatal, intravascular hemolysis in patients with immune thrombocytopenic purpura (ITP) treated with the intravenous human immune globulin product, WinRho SDF. In addition, the maltose in IVIG products, including the liquid formulation of WinRho SDF, produce falsely high blood glucose levels in some types of blood glucose testing systems.

The manufacturers' "Dear Healthcare Professional" letter recommends that patients be warned to immediately report any of the symptoms of intravascular hemolysis including back pain, shaking chills, fever, discolored urine, decreased urine output, sudden weight gain, fluid retention and/or shortness of breath.

"The impact of age, gender, pretreatment renal function, pretreatment hemoglobin, other concomitantly administered blood/blood products or significant co-morbid conditions may have had in the onset of DIC in any of these reports are not known. Analysis of these events indicates that the etiology is complex and the potential association with anti-D is not clearly understood," the letter states.

The letter also recommends that only glucose-specific testing systems be used with patients receiving WinRho SDF.

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