Manufacturers Voluntarily Recall Peginesatide.

Affymax and Takeda are voluntarily recalling all lots of OMONTYS® (peginesatide) Injection, an anemia drug for dialysis patients, due to new postmarketing reports of serious hypersensitivity reactions, including anaphylaxis, which can be life-threatening or fatal. The FDA agrees with this decision. The companies have also issued a letter to health care professionals stating that no new or existing patients should receive the drug. Fatal reactions have been reported in about 0.02% of more than 25,000 patients who received first-dose injections. Overall hypersensitivity reactions have been reported in approximately 0.2% of patients, with a third of these being serious.

The AP (2/25) reports Affymax Inc. and Takeda Pharmaceutical Co. issued a joint statement Friday, announcing they are voluntarily recalling "their anemia drug Omontys [peginesatide] after reports of severe allergic reactions in some kidney dialysis patients, including some deaths."

        The Wall Street Journal (2/25, Walker, Subscription Publication, 2.29M) adds that the companies said more than 25,000 patients with chronic kidney disease have been treated with Omontys, which the Journal notes has been marketed as a cheaper alternative to Amgen's Epogen (epoetin alfa). According to the National Institutes of Health, some of the patients who were administered Omontys, developed anaphylaxis.

        The New York Times (2/25, B3, Pollack, Subscription Publication, 1.68M) reports that the Food and Drug Administration followed the companies' statement with a notice on Sunday, saying, it "had received 19 reports of anaphylaxis" related to use of Omontys and "that three of the patients had died, while others required prompt medical intervention or hospitalization." Over all, the companies "said, about 2 of every 1,000 patients had a hypersensitivity reaction"; and the drug makers as well as the FDA "said the reactions occurred within 30 minutes of patients receiving their first dose by intravenous administration."

        Reuters (2/25, Topham, Viswanatha) quotes Howard Sklamberg, the director of the Compliance Office at the agency's Center for Drug Evaluation and Research, as saying, "Due to the severity of the public health risk, we want to be certain that healthcare providers stop using Omontys." Sklamberg added that the FDA is conducting an investigation at the facilities where the products under recall were produced, and he said the agency is planning to release an update once the audit has been completed.

        According to Bloomberg News (2/25, Ishikawa), Osaka, Japan-based Takeda and Palo Alto, California-based Affymax said all "lots of Omontys, sold in 10 milligram and 20 milligram vials, have been recalled and health-care professionals have been told patients shouldn't receive the drug." Bloomberg News points out that as of January, sales of Omontys, which was approved by the FDA last March, "tripled to $19 million," according to data from Symphony Health.

        MedPage Today (2/25, Gever) also reports the Omontys recall.