Peginesatide Recalled Due to Fatal Anaphylaxis

The anemia drug peginesatide (Omontys, Affymax and Takeda Pharmaceuticals) has been voluntarily recalled by the manufacturers, after reports of anaphylaxis leading to 3 deaths, the US Food and Drug Administration (FDA) announced today.
 
The FDA approved peginesatide in March 2012 for treating anemia, caused by chronic kidney disease, in adult patients receiving dialysis. The injectable drug is packaged in 10-mg and 20-mg multidose vials.

According to postmarketing reports from the manufacturers, roughly 0.2% of the 25,000 patients receiving the drug since its approval have experienced hypersensitivity reactions. One third of these cases have involved 19 cases of anaphylaxis and other serious adverse events that required prompt medical intervention and sometimes hospitalization. The 3 fatal reactions represent 0.02% of patients receiving peginesatide.
 
The serious hypersensitivity reactions reported to the FDA have occurred within 30 minutes of the first dose of intravenous administration, but not after any subsequent doses or after the completion of a dialysis session.
 
Clinicians and dialysis centers should immediately discontinue administering peginesatide and return the product to Takeda Pharmaceuticals, the FDA said.

More information about the recall is available on the FDA website.

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