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Severe Allergic Reactions, Death, Prompt Anemia Drug Recall

Filed February 25th, 2013 admin

The U.S. Food and Drug Administration (FDA), along with Takeda Pharmaceutical and Affymax, announced the recall of the recently-approved anemia drug, Omontys (peginesatide), which is used in patients undergoing kidney dialysis.

The recall, which involves all lots of Omontys, was made after the FDA received nearly 20 reports of Omontys causing severe allergic reactions in patients, with several reactions leading to death. The FDA said that it received 19 reports of severe allergic reactions to the drug, including three deaths, The New York Times said. Omontys began gaining traction after being approved last March and was the first alternative to Amgen, which had complete control of the anemia-treating market in kidney dialysis centers since 1989, The Times said. Affymax and Takeda jointly market Omontys.

The drug suppliers said that hypersensitivity reactions have led to fatalities in 0.02 percent of the 25,000 patients treated with Omontys since its approval. That translates into a total of five deaths, which is two more than the FDA is reporting, The Times said.

The FDA said all of the allergic reactions reported took place within 30 minutes of patients receiving their first dose by intravenous administration, The Times said. Takeda and Affymax, along with the FDA, recommend that Omontys use be halted by all patients, including those who have not had any issues with the drug. Earlier this month, Fresenius Medical Care North America stopped a pilot program testing Omontys, because of the discovery of allergic reactions, The Times said.

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