Anemia Drug Recalled Due to Reactions Among Dialysis Patients

February 24, 2013 | By More

A voluntary recall has been issued by the makers of the anemia drug Omontys because of reports that the treatment can cause serious, and sometimes fatal, hypersensitivity reactions in some kidney dialysis patients.

Takeda Pharmaceuticals Co., of Osaka, Japan, and Palo Alto, Calif.-based Affymax Inc. said in a joint statement on their websites Sunday that all lots of the drug have been recalled and doctors should stop prescribing Omontys (peginesatide). The medication is used to treat anemia in people with chronic kidney disease.

Among the first 25,000 patients who received a first injection of Omontys, .02 percent suffered fatal hypersensitivity reactions that included anaphylaxis shock, the companies said in their statement. The reaction typically occurred within 30 minutes of the first injection of Omontys.

Overall, about .2 percent of dialysis patients suffered some level of hypersensitivity reaction, and a third of those were serious enough to require medical intervention and sometimes hospitalization, the companies said in their joint statement.

“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 Takeda, Bloomberg News reported.

The U.S. Food and Drug Administration approved the treatment last March and has agreed to the recall, according to Bloomberg.

Category: Health and Fitness

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