The U.S. Food and Drug Administration (FDA) on Feb. 24 issued an alert to healthcare providers and patients regarding 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 FDA said the recall is due to reports of anaphylaxis after injection of the drug. 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," the alert stated.
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 alert said.
The FDA said it 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, the alert emphasized.
“Due to the severity of the public health risk, we want to be certain that healthcare providers stop using Omontys,” said Howard Sklamberg, director, Office of Compliance, FDA’s Center for Drug Evaluation and Research, in a prepared statement. “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.”
The FDA said Affymax and Takeda are investigating these adverse reactions.
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.
The FDA asks healthcare professionals and consumers to report any adverse reactions to Omontys to the FDA’s MedWatch program. There are two ways to submit a report:
- Complete and submit the report online.
- Download and complete the form, then submit it via fax at 1-800-FDA-0178.
Consumers may call 1-855-466-6689 for additional information.