June 24, 2010
FDA Video: Hemolysis Risk with WinRho SDF
Baxter Healthcare and Cangene Corporation are notifying healthcare professionals that intravascular hemolysis (IVH), which can be fatal, has occurred in patients with immune thrombocytopenic purpura treated with WinRho SDF, an intravenous immune globulin product. Intravascular hemolysis can lead to severe anemia, renal failure, acute respiratory distress syndrome, disseminated intravascular coagulation, and multi-system organ failure.
Elderly patients with co-morbid conditions appear to be at higher risk for developing acute hemolytic reactions.
Here are the recommendations that now appear in the boxed warning for this product:
- Closely monitor patients in a healthcare setting for at least eight hours after administering WinRho SDF. But be aware that IVH can occur even after that time.
- Perform a baseline dipstick urinalysis. Repeat this at two and four hours after administration, and at the end of the monitoring period.
- Instruct patients to watch for symptoms of IVH, including back pain, shaking chills, fever, discolored urine and hematuria.
- If you suspect IVH, confirm this with laboratory tests, including plasma hemoglobin, haptoglobin, LDH, direct and indirect plasma bilirubin, and dipstick urinalysis.