March 10, 2010
FDA warns of intravascular hemolysis risk with WinRho SDFThe FDA, Cangene, and Baxter have notified healthcare professionals that cases of intravascular hemolysis (IVH) and its complications have been reported in patients treated for immune thrombocytopenic purpura (ITP) with WinRho SDF [Rho(D) immune globulin IV (human)]. Some of these cases of IVH and its complications have been fatal. A Boxed Warning has been added to the WinRho SDF labeling which strengthens the warnings related to the risk of developing IVH in patients being treated for ITP.
WinRho SDF is indicated for the treatment of non-splenectomized, Rho(D) positive children with acute immune thrombocytopenic purpura (ITP); adults and children with chronic ITP and ITP secondary to HIV infection; and in clinical situations requiring an increase in platelet count to prevent excessive hemorrhage. WinRho SDF is also indicated for the suppression of Rh isoimmunization in nonsensitized Rho(D) negative women in appropriate obstetrical conditions, unless the fetus or father is known to be Rho(D) negative; as well as suppression of Rh isoimmunization in Rho(D) negative females after accidental transfusion of Rho(D) positive blood products.
For more information visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm203739.htm.