Unregistered User If this is not your name, click here.
		Contact Us | Order Now | Journals | Bookstore | Register a colleague
	Select a ChannelAcneAIDS and HIVAllergy OtherAlzheimer'sAnaesthesiology OtherAngina Pectoris/MIAnxietyArthritis OtherAsthmaBack PainBacterial InfectionsBladder CancerBone Marrow TransplantationBreast CancerCardiology OtherCataractCell TransplantationCervical CancerCholesterol/Lipid disordersCirrhosisClinical PharmacologyColorectal CancerCongestive Heart FailureContact DermatitisContraceptionCOPDCystic FibrosisDental and Oral DisordersDepressionDermatology OtherDiabetesDialysisEating DisordersElbowEmergency MedicineEndocrinology OtherEpilepsyErectile DysfunctionFibromyalgiaGastro OtherGeneticsGenitourinary OtherGeriatricsGERD/GastritisGlaucomaH. Pylori/UlcerHaematology OtherHair LossHeadachesHepa/Biliary OtherHepatitisHipHRTHypertensionIBDImmunologyInfectious OtherInfertilityIntensive CareIrritable Bowel SyndromeKneeLeukemiasLiver CancerLung CancerLupusLymphomasMelanomaMenopauseMultiple Sclerosis Nephrology OtherNeurologic OtherNutritional / Metabolic OtherOb/Gyn OtherObesityOncology OtherOphth. OtherOphthalmic SurgeryOrgan TransplantationOrthopaedics OtherOsteoarthritisOsteoporosisOtitisOtorhino. OtherOvarian CancerPaediatricsPainPancreatic CancerParkinson'sPregnancyProstate CancerPsychiatry OtherPulmonary OtherRadiologyRenal CancerRenal FailureRespiratory InfectionsRheumatoid arthritisRheumatology OtherRhinitisSchizophreniaShoulderSleep ApnoeaSleep DisordersSpineStrokeSTDsSurgeryThyroid DisordersTransfusionTransplant Surgery OtherTraumaUrinary IncontinenceUrinary tract infectionsVaccinologyVascular DisordersViral Infections

SEARCH   News Bookstore Medline The Web Meetings & Congresses Complete Doctor's Guide    EXPLORE :    All News   All Webcasts   All Cases   All Meetings & Congresses   All Medical Resources New drugs / indications English Dictionary Medical Dictionary Thesaurus Warning | Privacy | Awards  Favourite Journals  Click here to choose your favourite journals  Favourite Sites  Click here to choose your favourite sites  Languages  Select languageEnglishFrançais

FDA Update on Intravascular Haemolysis Risk With Immune Globulin Intravenous (Human) ROCKVILLE, Md -- March 10, 2010 -- The US Food and Drug Administration (FDA), Baxter, and Cangene, are notifying healthcare professionals that cases of intravascular haemolysis (IVH) and its complications, including fatalities, have been reported in patients treated for immune thrombocytopenic purpura (ITP) with human intravenous immune globulin (WinRho SDF). Intravascular haemolysis can lead to clinically compromising anaemia and multi-system organ failure including acute respiratory distress syndrome. Serious complications including severe anaemia, acute renal insufficiency, renal failure, and disseminated intravascular coagulation have also been reported. Fatal outcomes associated with IVH and its complications have occurred most frequently in patients of advanced age (> 65 years) with co-morbid conditions. The Boxed Warning informs healthcare professionals that: · Patients should be closely monitored in a healthcare setting for at least 8 hours after administration · A dipstick urinalysis should be performed at baseline, 2 hours, 4 hours after administration, and prior to the end of the monitoring period/’ · Patients should be alerted to and monitored for signs and symptoms of IVH, including back pain, shaking chills, fever, and discoloured urine or haematuria. Absence of these signs and/or symptoms of IVH within 8 hours do not indicate IVH cannot occur subsequently. · If signs and/or symptoms of IVH are present or if IVH is suspected after administration, post-treatment laboratory tests should be performed including plasma haemoglobin, urinalysis, haptoglobin, LDH and plasma bilirubin (direct and indirect). More information can be found here: http://www.fda.gov/downloads/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/FractionatedPlasmaProducts/UCM198725.pdf http://www.fda.gov/downloads/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/FractionatedPlasmaProducts/UCM198717.pdf SOURCE: US Food and Drug Administration E-mail this page to a friend or colleague! To print, use this version