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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 ...
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, ...