In US, Omontys Injection is recalled due to reports of anaphylaxis, a serious and life-threatening allergic reaction. Omontys is used to treat anemia in adult dialysis patients. Until further notice, health care providers should stop using Omontys.
According to the companies, serious and fatal hypersensitivity reactions have been reported in some patients receiving their first dose of Omontys, given by intravenous injection. The reactions have occurred within 30 minutes following the dose.
There have been no reports of reactions following subsequent dosing, or in patients who have completed their dialysis session.
The FDA has been notified by Affymax of 19 reports of anaphylaxis from dialysis centers in the United States. Three of the anaphylaxis cases resulted in death. Other patients required prompt medical intervention and in some cases hospitalization. Some of the reports included patients who were able to be resuscitated by doctors. However, anaphylaxis is life-threatening and resuscitation efforts are not always successful.
?Due to the severity of the public health risk, we want to be certain that health care providers stop using Omontys,? said Howard Sklamberg, director, Office of Compliance, FDA?s Center for Drug Evaluation and Research. ?Americans deserve medications that are safe, effective, and of the highest quality. We are investigating the products and facilities associated with this recall and will provide updates as we learn more.?
Anemia is common in adult patients who have chronic kidney disease (CKD) and who are on dialysis. Omontys, approved by the FDA in March 2012, is an erythropoiesis-stimulating agent (ESA) that aids in the formation of red blood cells. Additional ESA products are available to treat anemia, including Procrit, Epogen, and Aranesp.
Source: U.S. Food and Drug Administration, USA