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Affymax and Takeda Announce Recall of OMONTYS Injection

En Español

Omontys recall, anemia drug recallOn February 24, 2013 Affymax, Inc., and Takeda Pharmaceutical Company Limited issued a voluntary recall of OMONTYS , also known as peginesatide, injection due to user reports of potentially fatal hypersensitivity reactions.

OMONTYS is an injection given by a doctor on a monthly basis to adult patients on dialysis in order to treat anemia related to chronic kidney disease. However, since the drug’s launch, approximately .2% of patients have reported hypersensitivity reactions with nearly one third of these being severe in nature leading to anaphylaxis and requiring immediate medical attention and even hospitalization . Of all patients, nearly .02% have suffered fatal reactions following the first administered dose. The companies, who have been fully backed by the U.S. Food and Drug Administration (FDA) in the decision to recall the drug, have issued a letter to health care professionals instructing them not to administer the injection to any patients.

Consumers who have been affected by the OMONTYS recall are advised to contact the manufacturer for refund information.

If you are a patient requiring legal assistance after suffering serious adverse side effects from OMONTYS, please use the form on the page to contact our expert attorneys.