All lots of the new anemia drug peginesatide (Omontys, Takeda) have been recalled because of severe, sometimes fatal, hypersensitivity reactions.
More than 25,000 people have received the drug, an erythropoiesis-stimulating agent (ESA) that aids in the formation of red blood cells, since it was approved last March to treat adult patients on hemodialysis with anemia stemming from chronic kidney disease.
Since then drug-seller Affymax has notified the FDA of 19 reports of anaphylaxis from dialysis centers in the United States, three of which resulted in death. Other patients required prompt medical intervention and in some cases hospitalization, according to the agency.
“The rate of overall severe hypersensitivity reactions reported is approximately 0.2%, with approximately a third of these being serious in nature including anaphylaxis requiring prompt medical intervention and in some cases hospitalization,” Affymax and Takeda, said in a joint press release.
The drug is administered via injection and packaged in 10- and 20-mg multidose vials. All reported hypersensitive reactions have occurred after occurred within 30 minutes following administration of a patient’s first dose. There have been no reports of reactions following subsequent dosing, or in patients who have completed their dialysis session.
The FDA is advising all dialysis clinics stop using the product immediately and is urging healthcare provider to return the product to the manufacturer. Additional ESA products are available to treat anemia, including Procrit, Epogen and Aranesp.
Adverse reactions or quality problems experienced with the use of peginesatide should be reported online to the FDA’s MedWatch Adverse Event Reporting program, or can be downloaded here and faxed to 1-800-FDA-0178.