TOKYO/WASHINGTON U.S.-based Affymax Inc and Japan's Takeda Pharmaceutical Co said they are voluntarily recalling all lots of anemia treatment Omontys (peginesatide) in the United States due to reports of serious hypersensitivity reactions, including some deaths.
As of Sunday, fatal reactions to the injection have been reported in about 0.02 percent of 25,000 patients after receiving their initial injection of the treatment, Affymax said in a statement.
The drug is used to treat anemia in adult dialysis patients, and has resulted in reports of serious allergic reactions known as anaphylaxis in some recipients.
The U.S. Food and Drug Administration on Sunday alerted healthcare providers about the recall, and said it had received 19 reports of anaphylaxis from dialysis centers in the United States.
"Due to the severity of the public health risk, we want to be certain that healthcare providers stop using Omontys," said Howard Sklamberg, who heads the compliance office at the FDA's Center for Drug Evaluation and Research.
Sklamberg said the agency is investigating the products and facilities related to the recall and will provide updates once it receives more information.