Sunday, March 14, 2010

FDA : New Boxed Warning for WinRho SDF

Rho(D) immune globulin intravenous (WinRho SDF) get a black box warning about the risks of treating patients with immune thrombocytopenic purpura (ITP) after reports of some patients dying from intravascular hemolysis (IVH), per the FDA.

Some ITP patients treated with the immunoglobulin have developed IVH, which can lead to clinically compromising anemia and multisystem organ failure, including acute respiratory distress syndrome, according to an alert sent today by MedWatch, the FDA's safety information and adverse event reporting program.

Other serious complications reported after administration of WinRho SDF are severe anemia, acute renal insufficiency, renal failure, and disseminated intravascular coagulation, according to the FDA.