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FDA Recalls Affymax Omontys


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 (NASDAQ: AFFY) 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

See full press release

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