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FDA Recalls Anemia Drug, Omontys (Peginesatide)

Recall due to anaphylaxis and some deaths (Feb. 24)

The FDA is alerting health care providers and patients of a voluntary nationwide recall of all lots of Omontys (peginesatide) injection by the drug’s manufacturers, Affymax, Inc. and Takeda Pharmaceuticals Company Limited. The recall is due to reports of anaphylaxis, a serious and life-threatening allergic reaction. Omontys is used to treat anemia in adult dialysis patients.

Until further notice, health care providers should stop using Omontys and return the product to Takeda Pharmaceuticals, the agency says.

Serious and fatal hypersensitivity reactions have been reported in some patients receiving their first dose of Omontys, given by intravenous injection. The reactions have occurred within 30 minutes after the dose. There have been no reports of reactions following subsequent dosing, or in patients who have completed their dialysis session.

The FDA has been notified by Affymax, Inc. of 19 reports of anaphylaxis from dialysis centers in the U.S. Three of the anaphylaxis cases resulted in death. Other patients required prompt medical intervention and, in some cases, hospitalization. Some of the reports included patients who were able to be resuscitated by physicians. However, anaphylaxis is life-threatening, and resuscitation efforts are not always successful, the FDA notes.

Anemia is common in adult patients with chronic kidney disease who are on dialysis. Omontys (peginesatide) — approved by the FDA in March 2012 — is an erythropoiesis-stimulating agent that aids in the formation of red blood cells.

Sources: FDA; February 24, 2013; and Affymax, Inc.; February 2013.

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