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Hemolytic Uremic Syndrome News
FDA Medwatch Alert: Soliris (eculizumab) Concentrated Solution for IV Infusion by Alexion: Recall - Visible Particulates
Posted 3 Jun 2014 by Drugs.com
ISSUE: Alexion Pharmaceuticals, Inc. announced that it is initiating a voluntary recall of certain lots of Soliris (eculizumab) 300mg/30 mL concentrated solution for intravenous infusion. The administration of particulate, if present in a parenteral drug, poses a potential safety risk to patients in two general areas: immune reaction and blood clots. Particulates could cause blockage of flow of blood in vessels, which could be life-threatening. The single affected Soliris lot is #10007A. Although these lots currently remain in specification, Alexion is including the following remaining lots, which were produced with the same process component during vial filling, within the scope of the U.S. recall: 10002-1, 00006-1, 10003A, 10004A, 10005A, 10005AR, 10006A and 10008A. BACKGROUND: Soliris is approved as a treatment for patients with paroxysmal nocturnal hemoglobinuria (PNH) and atypical ... Read more
Soliris (eculizumab) Approved by FDA for All Patients with Atypical Hemolytic Uremic Syndrome (aHUS)
Posted 25 Sep 2011 by Drugs.com
CHESHIRE, Conn.--(BUSINESS WIRE)--Sep 23, 2011 - Alexion Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved Soliris® (eculizumab) for the treatment of all pediatric and adult patients with atypical hemolytic uremic syndrome (aHUS). aHUS is an ultra-rare, life-threatening, genetic disease that progressively damages vital organs, leading to stroke, heart attack, kidney failure and death.1 The morbidity and premature mortality in aHUS is caused by chronic uncontrolled activation of the complement system, resulting in the formation of blood clots in small blood vessels throughout the body, known as thrombotic microangiopathy or TMA.2,3 Despite current supportive care, more than half of all patients with aHUS die, require kidney dialysis or have permanent kidney damage within 1 year of diagnosis.4 Soliris, a first-in-class terminal complement ... Read more