All lots of a new anemia drug used for patients undergoing kidney dialysis have been recalled over reports of severe, sometimes deadly, allergic reactions. Affymax and Takeda Pharmaceutical jointly market Omontys (peginesatide).
The drug suppliers’ announcement was also announced by the U.S. Food & Drug Administration, said The New York Times. The recall was announced Saturday and the agency issued a news release on Sunday, stating it received 19 anaphylaxis reports and that three patients died. Other patients needed immediate medical intervention or hospitalization. Physicians were able to resuscitate patients in some cases, said Bloomberg Businessweek.
“Serious and fatal” hypersensitivity reactions have been reported in some patients within 30 minutes of receiving their first dose of the drug by intravenous injection, the FDA said in the statement, wrote Bloomberg Businessweek. The agency said no reports of reactions have been received in subsequent doses or in patients who have concluded their dialysis session.
Omontys was approved March 2012 and was seen as competition to Amegen’s drug, Epogen, which had been the only anemia treatment used in dialysis clinics since 1989, said The Times. Bloomberg Businessweek noted that Omontys is sold in 10 and 20 milligram vials and is used to minimize anemia in kidney dialysis patients, who sometimes suffer from low red blood counts. Amgen’s Epogen is a synthetic form of the human protein erythropoietin, or EPO. EPO, explained The Times, and stimulates the body to produce red blood cells, which carry oxygen throughout the body. Although not an EPO, Omontys does bind to the same body’s receptor.
The Times pointed out that reports of severe allergic reactions have been mounting and both the Omontys and Epogen labels warn of these reactions.
Meanwhile, according to Affymax and Takeda, the serious hypersensitivity reactions caused death in 0.02 percent of some 25,000 patients treated with Omontys since the drug was approved. This means, said The Times, that there have been five, not three deaths; the discrepancy remains unexplained. According to the drug suppliers, about two in every 1,000 patients suffers a hypersensitivity reaction.
Affymax, Takeda, and the FDA said the reactions took place within 30 minutes of the initial intravenous dose and problems were not reported with follow-up doses, The Times wrote. The drug suppliers and agency said that Omontys be discontinued even in those patients treated with multiple doses. It has not yet been decided if Omontys will be withdrawn form the market and it is possible that physicians can take steps to avoid or minimize first-dose allergic reactions; it is not clear if the problems have been limited to specific dialysis centers, noted The Times.
An Affymax spokeswoman told The Times that executives would not be issuing any further comment pending a securities analyst conference call today. Kazumi Kobayashi, spokesman for Osaka-based Takeda, told Bloomberg Businessweek that, “Our company is working with the FDA and Affymax and decided to voluntarily recall Omontys to put patients’ safety first…. We will swiftly provide information to patients and health-care professionals.”