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Pharmas Recall Anemia Drug for Dialysis Patients

Blood bag (NIH)

(National Institutes of Health)

Affymax Inc. in Palo Alto, California and Takeda Pharmaceuticals Company in Osaka, Japan are recalling its drug Omontys in the U.S. after reported cases of anaphylaxis, a serious and life-threatening allergic reaction. The recall is being coordinated with the U.S. Food and Drug Administration.

Omontys, the branded form of the drug peginesatide, is a synthetic peptide prescribed to treat anemia in adult dialysis patients. The drug is given once a month as an intravenous (IV) injection. FDA approved Omontys in March 2012 following two phase 3 clinical trials of the drug’s safety and efficacy.

The companies say more than 25,000 patients received Omontys. Some 0.2 percent exhibited reported hypersensitivity reactions, about one-third of which requiring hospitalization. The companies indicate fatal reactions have been reported in some 0.02 percent of patients following the first IV dose, within 30 minutes after the drug’s administration. There have been no reports of reactions following subsequent dosing, or in patients who have completed their dialysis session.

Anaphylaxis is a severe, whole-body allergic reaction to a chemical that often happens quickly. FDA says it received via Affymax 19 reports of anaphylaxis from dialysis centers in the United States, of which three cases resulted in death. Other patients required prompt medical attention and in some cases hospitalization. While some of the reports included patients who were able to be resuscitated by doctors, says FDA, resuscitation efforts are not always successful.

The companies and FDA are advising dialysis providers to stop using Omontys and return their stocks to the manufacturer. The recall order also includes Omontys given to patients for home use.

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Hat tip: FirstWord Pharma

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