February 25, 2013
Anemia Drug Omontys Recalled By Affymax And Takeda After Anaphylaxis Reports
redOrbit Staff & Wire Reports - Your Universe Online
Two pharmaceutical companies have issued a recall of their anemia drug Omontys after receiving reports that some kidney dialysis patients had suffered severe allergic reactions after taking the medication.
According to the Associated Press (AP), California-based Affymax Inc. and Illinois-based Takeda Pharmaceutical Co. said some of the more than 25,000 patients who had received the drug had experienced adverse effects afterwards, and a few of those individuals had died as a result of those allergic reactions.
An estimated 0.02-percent of those patients had fatal reactions following their initial Omontys injection, Reuters reported on Sunday. The US Food and Drug Administration (FDA) alerted healthcare providers about the recall over the weekend, noting they had received “19 reports of anaphylaxis from dialysis centers” nationwide, they added.
“Due to the severity of the public health risk, we want to be certain that health care providers stop using Omontys,” Howard Sklamberg, Director of the Office of Compliance at the FDA´s Center for Drug Evaluation and Research, said in a statement. “Americans deserve medications that are safe, effective, and of the highest quality. We are investigating the products and facilities associated with this recall and will provide updates as we learn more.”
“The companies said that 0.2 percent of the patients who have received the drug, or about 50, have reported severe allergic reactions,” the AP added. “The serious hypersensitivity reactions occur within 30 minutes of the drug being administered for the first time. The companies said that no such reactions have been reported subsequent times that the drug is administered to a patient.”
Affymax and Takeda are advising dialysis centers to immediately cease use of the anemia drug, and Omontys users will be provided with instructions on how to return the unused portion of their medication to the manufacturers for a refund, the wire service said. Anyone with questions pertaining to the recall should call 1-855-466-6689 from 9:00am to 5:00pm Eastern, Monday through Friday.
“Anemia is common in adult patients who have chronic kidney disease (CKD) and who are on dialysis,” the FDA said Sunday in a recall notice. “Omontys, approved by the FDA in March 2012, is an erythropoiesis-stimulating agent (ESA) that aids in the formation of red blood cells. Additional ESA products are available to treat anemia, including Procrit, Epogen, and Aranesp.”