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FDA: Providers should stop using Omontys Injection

Wednesday March 6, 2013
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The Food and Drug Administration has alerted healthcare providers and patients of a voluntary nationwide recall of all lots of Omontys Injection by Affymax, Inc., of Palo Alto, Calif., and Takeda Pharmaceuticals Company Limited, of Deerfield, Ill.

The recall is due to reports of anaphylaxis. Omontys is used to treat anemia in adult dialysis patients.

Until further notice, healthcare providers should stop using Omontys and return the product to Takeda Pharmaceuticals, according to the FDA.

The companies have stated that 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 anaphylaxis cases resulted in death. Other patients required prompt medical intervention and in some cases hospitalization. Some reports included patients who were able to be resuscitated by doctors. However, anaphylaxis is life-threatening, and resuscitation efforts are not always successful, the FDA noted.

"Due to the severity of the public health risk, we want to be certain that healthcare providers stop using Omontys," Howard Skalmberg, director of the Office of Compliance, in the FDAs Center for Drug Evaluation and Research, said in a news release. "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 and who are on dialysis. Omontys, approved by the FDA in March 2012, is an erythropoiesis-stimulating agent that aids in the formation of red blood cells. Additional ESA products are available to treat anemia, including Procrit, Epogen and Aranesp.

Affymax and Takeda are investigating these adverse reactions. Customers may call 855-466-6689 for additional information.

The FDA asks healthcare professionals and consumers to report any adverse reactions to the FDAs MedWatch program (www.fda.gov/Safety/MedWatch/HowToReport/default.htm).

More information is available in the manufacturers press release, posted on the FDAs website at www.fda.gov/Safety/Recalls/ucm340893.htm.


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