Takeda Pharmaceutical Co. and Affymax Inc. have voluntarily announced an anemia drug recall for the Omontys (peginesatide) injection, a drug used for anemia treatment in kidney dialysis patients, because of “serious, life threatening or fatal hypersencitivity reactions,” including anaphylaxis.
The companies recalled all Omontys lots, both sold in 20 mg and 10 mg vials. Doctors have been told not to administer the medication to patients due to the anemia drug recall. The FDA agrees with the voluntary anemia drug recall taken by the two companies. The Omontys (peginesatide), an erythropoietic agent, a functional analog of erythropoietin, was approved by the FDA (Food and Drug Administration) for anemia associated with chronic kidney disease in adult patients on dialysis.
Out of approximately 25,000 patients taking Omontys, 0.02 have had fatal reactions after being administered their first dose., said a Takeda spokesman. In about 1 in every 500 cases, hypersensitivity reactions (anaphylaxis) have been serious enough to require the attention of a doctor – some of the patients had to be admitted to hospital. The company emphasized that there have been no reports of such reactions after subsequent administrations of drug. In other words, the reactions of concern only occur after the first application of the drug, not second, third, etc.
“Our company is working with the FDA and Affymax and decided to voluntarily recall Omontys to put patients’ safety first. We will swiftly provide information to patients and health care professionals.” said Takeda spokesman, Kazumi Kobayashi.
Takeda says that customers will receive instruction on how to return the medication to the manufacturer for a full refund due to the anemia drug recall. If you are a customer and have any questions, you are invited to telephone 1-855-466-6689. The helpdesk is staffed from 9am to 5pm Monday to Friday, Eastern Standard Time.
The FDA invites patients and healthcare professionals to report reactions or quality problems related to Omontys usage to the Agency’s MedWatch Adverse Event Reporting program either:
- By fax – 1-800-FDA-0178
- Online at www.fda.gov/medwatch/report.htm
- Regular mail. Use a postage-paid, pre-addressed Form FDA 3500. Mail to the pre-addressed details on the form. The form is available atwww.fda.gov/MedWatch/getforms.htm