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Affymax, Takeda Recall Anemia Drug Following ‘Serious’ Reactions

Update Date: Feb 24, 2013 07:03 PM EST
Drug Recall
Affymax and Takeda Announce a Nationwide Voluntary Recall of All Lots of Omontys (Photo : REUTERS/Chaiwat Subprasom)

Japanese drug manufacturer Takeda Pharmaceutical Co. and U.S.-based Affymax Inc. issued a recall on Sunday of their anemia drug Omontys used for kidney dialysis patients following reports of serious hypersensitivity reactions among several users which even resulted in some deaths.

The U.S. Food and Drug Administration (FDA), which approved Omontys in March, agreed to the recall, the companies said in a joint statement.  The companies also issued a letter to health care professionals indicating that no new or existing patients should receive Omontys injection.

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Fatal reactions have occurred in approximately 0.02% of 25,000 patients and the reaction has occurred within 20 minutes of administration of the injection. More than 25,000 patients have received Omontys since its release.  The FDA said it had received 19 reports of anaphylaxis from dialysis centers in the United States.

The companies said that no such reactions have been reported subsequent times that the drug is administered to a patient.

"Our company is working with the FDA and Affymax and decided to voluntarily recall Omontys to put patients' safety first," said Kazumi Kobayashi, a spokesman for Osaka-based Takeda said, according to the Assocaited Press. "We will swiftly provide information to patients and health-care professionals."

Customers with questions can call 1-855-466-6689 from 9:00 a.m. to 5:00 p.m. EST Monday through Friday. The two companies said they were working with the U.S. Food and Drug Administration on the details of the recall.

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