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Peginesatide Recalled Because of Fatal Reactions

June 9, 2014

Peginesatide Recalled Because of Fatal Reactions

  1. David Green, MD, PhD

The anemia drug for adults on dialysis was associated with severe anaphylaxis and hypotension.

  1. David Green, MD, PhD

Peginesatide was approved for the treatment of anemia in patients with renal disease in 2012. Studies demonstrated that the agent was as effective as erythropoietin, but cardiovascular adverse events were more common (NEJM JW Oncol Hematol Jan 23 2013).

Between July 2012 and February 2013, 61,482 doses of peginesatide were given to 19,540 patients. Eleven patients experienced severe anaphylaxis and hypotension, 5 of whom died; an additional 17 patients had milder anaphylaxis and hypotension. The drug has been recalled by the manufacturer.

Comment

Peginesatide had the advantage of once-monthly administration, but the unpredictable nature and the severity of its adverse effects led to its withdrawal. Erythropoietin and darbepoietin remain the standard of care for the anemia of chronic kidney disease.

  • Disclosures for David Green, MD, PhD at time of publication Consultant / Advisory board Altor Bioscience Grant / Research support NIH

Citation(s):

Reader Comments (1)

Muhammad Khalid Idreed Physician, Nephrology, SIUT Karachi Pakistan

Peginesatide could be an ideal drug for patients in our country where drug supply and storage is problematic. It was however too costly. Atleast CERA e.g. Micera should be easily and economically available for our ESRD patients on dialysis.

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