FDA issues recall for anemia drug Omontys
Omontys, manufactured by Affymax, Inc. and Takeda Pharmaceuticals, Ltd., is used to treat anemia in adult dialysis patients. The recall is due to reports of anaphylaxis, a serious and life-threatening allergic reaction.
Houston, TX March 7, 2013 – The U.S. Food and Drug Administration is alerting health care providers and patients of a voluntary recall of all lots of Omontys injection.
Omontys, manufactured by Affymax, Inc. and Takeda Pharmaceuticals, Ltd., is used to treat anemia in adult dialysis patients. It is a man-made protein that aids in the formation of red blood cells after kidney failure or medication has reduced red blood cell count.
The recall is due to reports of anaphylaxis, a serious and life-threatening allergic reaction. Since its launch in March 2012, about 25,000 patients have been treated with Omontys and about 50 of those patients have experienced hypersensitivity.
The FDA has received reports of 19 patients who experienced anaphylaxis from dialysis centers. These patients required immediate medical intervention and resuscitation. Despite resuscitation efforts, three of these reports resulted in death. These serious reactions occurred within 30 minutes of patients receiving their first dose of Omontys. No reports have been submitted of reactions occurring after subsequent dosing or after completion of their dialysis session.
The FDA, along with Affymax and Takeda, are now doing an investigation of this product and the adverse reactions. It is not clear if the recall will result in Omontys being taken off the market permanently; however, health care providers should stop using Omontys and return any unused product until the investigations are complete.
Any incidences of adverse reactions to Omontys should be reported immediately to the FDA.
D. Miller & Associates, PLLC is dedicated to helping those affected by Omontys. If you or someone you love has suffered an allergic reaction after taking Omontys, it is important to discuss your legal rights with an attorney.
You could receive compensation for medical expenses, lost income, pain and suffering and much more. You have a limited time to file an Omontys lawsuit so contact our lawyers immediately for your free case evaluation.
About D. Miller & Associates, PLLC:Founded in 2002 by attorney Darren Miller, D. Miller & Associates, PLLC is a premiere national law firm with practice areas in personal injury, asbestos and mesothelioma, defective drugs and devices, business and criminal law.
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