Nationwide Recall of Omontys® Following Reports of Severe Allegic Reactions, Some Fatal

Omontys-recall-allergic-reactionAffymax, Inc. and Takeda Pharmaceutical Company Limited have announced a voluntary recall of Omontys® (peginesatide), a drug used to treat anemia in kidney dialysis patients, as a result of new reports of serious and sometimes fatal hypersensitivity reactions.

The companies have been working actively with the U.S. Food and Drug Administration (FDA) and the recall was announced through the FDA on February 23. The companies have sent a letter to health care professionals indicating that no new or existing patients should receive Omontys®.

Omontys® (peginesatide) Injection is used for the treatment of anemia due to chronic kidney disease (CKD) in adult patients on dialysis. To date, fatal reactions have been reported in approximately 0.02% of patients following the first intravenous dose. The reported serious hypersensitivity reactions have occurred within 30 minutes after the administration of Omontys®. There have been no reports of such reactions following subsequent doses, or in patients who have completed their dialysis session. Since the drug’s approval in March 2012, more than 25,000 patients have received Omontys® in the post-marketing setting. Approximately a third of the overall reactions reported have been serious in nature, including anaphylaxis, a severe allergic reaction requiring prompt medical intervention and in some cases hospitalization.

Adverse reactions or quality problems with Omontys® may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax. Information and forms are available at www.fda.gov/medwatch/report.htm.

Affymax and Takeda are actively investigating these cases. In the meantime, dialysis organizations are instructed to discontinue use. Customers will be provided instructions on how to return the product to the manufacturer for a refund. Customer information is available at 1.855.466.6689 from 9:00 a.m. to 5:00 p.m. Eastern Standard Time, Monday through Friday.

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